Intramedullary Nailing Versus External Fixation in the Treatment of Open Tibia Fractures in Tanzania - Results of a Randomized Controlled Trial
Phase: NA
Conditions: Tibial Fractures, Open Fracture of Tibia, Trauma
Sponsor: University of California, San Francisco

 
1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The MOI Open Tibia Study 
 
Intramedullary Nailing versus External Fixation for OTA42 Open Tibia Fractures: a Randomized 
Control Trial in Dar es Salaam - Tanzania 
 
 
 
 
 
 
Standard Operating Procedures 
 
 
Last Updated: April 22, 2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
2 
 
 
 
 
Table of Contents 
 
Key Study Contacts ...................................................................................................................................... 3 
1. Summary of Changes to Standard Operating Procedure ..................................................................... 4 
2. Background & Significance ..................................................................................................................... 6 
2.1 Significance: Extremity Trauma as Global Epidemic ...................................................................... 6 
2.2 Innovation:  Advancing Evidence Based Fixation of Severe Open Tibia Fractures ....................... 6 
2.3 Preliminary Data ................................................................................................................................ 8 
3. Specific Aims............................................................................................................................................ 8 
4. Methods ................................................................................................................................................... 9 
4.1 Outcomes ......................................................................................................................................... 10 
4.2 Sample Size ..................................................................................................................................... 11 
4.3 Timeline ........................................................................................................................................... 11 
5. Study Procedures .................................................................................................................................. 12 
5.1 Screening ......................................................................................................................................... 12 
5.2 Radiographs .................................................................................................................................... 14 
5.3 Quality Control ................................................................................................................................. 15 
5.4 Wound Measurement and Classification ...................................................................................... 15 
5.5 Damage Control .............................................................................................................................. 16 
5.6 Randomization ................................................................................................................................ 16 
5.7 Definitive Treatment ....................................................................................................................... 16 
5.8 Follow-up Schedule ......................................................................................................................... 17 
5. 9 Study Financial Coverage .............................................................................................................. 18 
5.10 Adjudication Review...................................................................................................................... 19 
6. REDCAP Procedures .............................................................................................................................. 21 
6.1 Enrollment form – Screening and Consent ................................................................................... 21 
6.2 Intra-operative/Discharge Form ..................................................................................................... 33 
6. 3 Baseline Image Upload .................................................................................................................. 36 
6.4 Post-Op Discharge ........................................................................................................................... 39 
6.5 Follow-up Evaluation Form ............................................................................................................. 43 
6.6 Complications and Review Form .................................................................................................... 51 
6.7 Follow-up Image Upload/Eval Form ............................................................................................... 56 
6.8 Follow-up Scheduling ...................................................................................................................... 59 
6.9 Uploading Images............................................................................................................................ 65 
References ................................................................................................................................................. 67 
Appendix and Supporting Documents .................................................................................................. 68 
Appendix II: Informed Consent Form - Swahili version ............................................................................ 77 
 
 

 
3 
 
 
 
 
Key Study Contacts 
 
Muhimbili 
 
Edmund Eliezer 
Mobile: +255 (0)753 100 500 
Email: ndalama@yahoo.com 
Skype Address: edmund.eliezer 
 
Billy Haonga 
Mobile: +255 (0)754 563 761 
Email: bilhaonga@hotmail.com 
 
Joshua Ngahyoma 
Mobile: +255 (0)754 093 998 
Email: skandoj@yahoo.co.uk 
Skype Address: joshua.ngahyoma77 
 
Justin Kessy 
Mobile: +255 (0)718 038 645 
Email: kessygasto53@yahoo.com 
Skype Address: justin.kessy1 
 
Ibrahim Sasillo 
TZ Mobile 1: +255 (0)713 480 302 
TZ Mobile 2: +255 (0762 572 848 
Email: namensa@yahoo.com 
 
Stanford University School of Medicine 
 
Max Liu 
291 Campus Drive 
Stanford, CA 94305  
US Mobile: +1-510-691-8034 
TZ Mobile: +255-688-633947 
Email: maxliu@stanford.edu 
Skype address: max.b.liu 
 
Amy Ladd 
450 Broadway Street 
Stanford, CA 94305 
Email: alad@stanford.edu  
US Mobile: +1-650-498-7555 
 
UCSF 
 
David Shearer 
University of California, San Francisco 
500 Parnassus Ave, MU320W 
San Francisco, CA 94143 
Mobile: +1-206-708-5845 
Email: shearerd@orthosurg.ucsf.edu 
Skype Address: daveshearermd 
 
Saam Morshed 
University of California, San Francisco 
2550 23rd Street 
Building 9, 2nd Floor 
San Francisco, CA 94110 
Mobile: +1-415-206-8812 
Email: MorshedS@orthosurg.ucsf.edu 
Skype Address: saam_morshed 
 
Kurt Yusi 
University of California, San Francisco 
500 Parnassus Ave, MU320W 
San Francisco, CA 94143 
US Mobile: +1-415-806-4091 
Email: kurt.yusi@ucsf.edu  
 
 
 
 
 
 
 
 

 
4 
 
 
 
 
1. Summary of Changes to Standard Operating Procedure 
 
February 3, 2016 (Max Liu) 
Various items that required clarification arose after the first few weeks of the study. The 
following clarifications were agreed upon: 
 
• Damage Control: Allowed (definitive treatment done within 2 weeks after first 
operation) 
• Exfix Pin-Care: 2 weeks with dressing and BID pin wash with alcohol. Check at 2 week 
follow up. If dry, remove dressing. If discharge present, continue with dressing and 
additional evaluations before 6 weeks 
• Exfix Treatment: 3 months then the following at surgeons discretion to be 
documented in eval form (1) removal, (2) removal with cast, (3) delayed exfix 
removal, or (4) other. Delayed exfix removal or other will be submitted for 
adjudication review 
• Antibiotics: 3 options at surgeons discretion with (1) CTX, (2) CTX + gentamycin, (3) 
CTX + gentamycin + metronidazole  
• Weight Bearing Protocol (all patients): 6 weeks toe touch then at surgeon's discretion 
• Nurses: 2 per week (number of patients will increase next Saturday) 
• # IM Nail Interlocks: 4 total on all nailed patients (2 prox, 2 distal) 
• Continue with study without interruption: Yes 
• Cohort Study: Will now include non-primarily closeable patients (we will attempt to 
contact the patients who came in since the start of the study) 
 
There was also a patient "borderline" fracture who will be included and followed-up. We have 
made a note and can exclude during data analysis if necessary.  
 
February 13, 2016 (Max Liu) 
Following the presentation of an open tibia patient approximately 3 days after their injury, a 
discussion occurred regarding whether or not an upper limit would be set for patients in the cohort 
study who present >24 hours post-injury. 
➔ It was decided that there would be no upper limit. 
April 6, 2016 (Max Liu) 
➔ It was decided that exfix patients who receive a cast will have the cast paid for by the study 
since it is a complication of their randomization (and not part of their typical treatment plan) 
➔ Max will send out a revised budget 
April 10, 206 (Max Liu) 
Kurt noticed during his site visit to MOI that there was underreporting of pin tract infections in the 
external fixation group. Previously, the question, “are the schanz pin tracts infected?” would only 

 
5 
 
 
 
 
appear if a surgical site infection was identified and reported under the question, “does the patient 
have any wound problems?” The underreporting may have been due to ambiguity in this question 
and the responses that were available.  
In the scheme of things, this does not have too bad of an effect on the data because it was only for 
the first 40 patients. Some of these had wound infections so they saw the question and others might 
not have had pin tract infection. Thus we only missed those who did not have a wound infection but 
did have a pin tract infection in exfix group in first 3 months of the study. 
➔ It was decided that the question “are the schanz pin tracts infected?” would appear for all 
external fixation patients regardless of the response to the question “does the patient have 
any wound problems?” Due to the difficulty of tracking at what time point patients get their 
external fixators removed, this question will appear at all follow-up visits even after the 
external fixator may have been removed. An option “N/A – the external fixator has already 
been removed” is provided in this situation. 
April 13, 2016 
➔ Amber stated that study related travel for Max (beyond his allotted Doris Duke funding) and 
others would be compensated under the study budget. Max will revise the budget 
accordingly.  
April 22, 2016 
In order to streamline where complications are recorded, the following recommendations were made 
by Saam and Dave: 
➔ Infections and wound complications will be moved to the “Complications and Review Form” 
➔ If a complication was previously recorded for a patient, a prompt will appear on subsequent 
follow-up forms asking the team to review the complications form and make any necessary 
updates 
 
 
 
 
 
 
 
 
 

 
6 
 
 
 
 
2. Background & Significance  
 
2.1 Significance: Extremity Trauma as Global Epidemic 
 
More than 75% of the global population lives in low and middle-income countries (LMICs) 
where rates of extremity injury average 2-5 times higher than high-income countries (HICs).1  Higher 
mortality rates in LMICs have been directly linked to the expanding use of motorized transport within 
the context of underdeveloped trauma care systems.2  As evidence of this growing epidemic, road 
traffic crashes are predicted to become the eighth leading cause of death and the fourth leading 
cause of disability worldwide by 2030.3   
The World Health Organization (WHO) projects Africa’s road trauma burden, currently the 
highest in the world (19.1-28.3/100,000), to increase by 80% between 2000 and 2020.4  On this 
continent better known for its battle with HIV, tuberculosis, and malaria, injuries account for more 
deaths among children ages 5-14 than all three infectious diseases combined.5   
To shape the focus of our proposed study, we focused our efforts where the clinical need is 
greatest.  Epidemiologic data indicate that open tibia and fibula fractures constitute the most 
common open long bone fracture encountered in orthopedic practice, and most often result from 
road traffic accidents.6  This data is consistent with the MOI experience, where 96.2% of patients 
enrolled in our pilot study suffered open tibia fractures resulting from motorcycle or motor vehicle 
accidents.  
Tibia fractures constitute severe, potentially limb-threatening injuries.  Sixteen percent of 
patients in our preliminary study sustained associated injuries (18.5% musculoskeletal, 9.3% 
Traumatic Brain Injury). This is consistent with prior research documenting the prevalence of multiple 
open fractures at 6.4%, an average injury severity score of 14 (Range 1-75), and more severe 
fractures associated with motorcycle accidents.7  Authors of the landmark Lower Extremity 
Assessment Project (LEAP) study which prospectively followed outcomes of patients with severe 
open diaphyseal tibia fractures found that nearly 33% of patients with Gustilo and Anderson Type 3 
injuries available at 2 year follow-up underwent early amputation due to initial injury severity.8  
Patients with open tibia fractures also suffer from high complication rates, as the bone’s 
precarious blood supply and relative lack of soft-tissue coverage compromise the healing process. 
The LEAP authors reported high rates of infection (11% to 38%), nonunion (7% to 60%), and 
secondary operative procedures.8  In their seminal 1984 paper, Gustilo and Anderson demonstrated 
the correlation of infection rates with increasing severity of injury by roughly an order of magnitude, 
as measured by their eponymous classification.9  This finding was confirmed by Papakostidis et. al., 
in a systematic review of 30,260 open tibial shaft fractures published in 2011.10  Tibia fracture 
complications lead to high rates of functional disability due to the importance of the tibia to lower 
extremity alignment, stability, and strength. 
Adding demographic insult to injury, road traffic accidents resulting in severe open tibia 
fractures predominantly impact young men. Patients in our preliminary study were largely male 
(77.8%) and averaged 34 years of age. Thus, these injuries disable the most economically productive 
demographic in developing economies.  Lost income over the average 6-8 month time required for 
return to work has a devastating impact on home finances.  The economic implications of these 
injuries cascade through communities generating cycles of debt, poverty, and family hardship.  
Additionally, these high acuity patients require vast curative resources, overburdening an already 
under-resourced health system.  
 
2.2 Innovation:  Advancing Evidence Based Fixation of Severe Open Tibia Fractures 
 

 
7 
 
 
 
 
The optimal method of surgical fixation for severe tibial shaft fractures continues to be a 
popular topic in the orthopaedic literature.  Despite thirty years of global research comparing 
external fixation to intramedullary nailing, controversy on the subject persists.  Of the more than ten 
comparative studies published in the literature, most utilized retrospective, non-randomized 
research designs.  Authors of previous meta-analyses note widespread bias toward external fixation 
with increased fracture severity, despite good evidence supporting both fixation methods for Gustilo 
3A (and even 3B) fractures. This bias further highlights the need for prospective, randomized 
treatment group allocation.  Additionally, authors of the most comprehensive systematic reviews 
note that high rates of allocation group heterogeneity confound comparison of results across 
studies.  To date, there has been no randomized, prospective, adequately powered trial evaluating 
external fixation versus undreamed intramedullary nailing and no comparative trial of external 
fixation with reamed nailing technique.11, 12   
Proponents of external fixators argue that these devices can be applied rapidly with relative 
ease without radiographic guidance, and entail limited insult to already traumatized soft tissues.  A 
major additional advantage in Sub-Saharan Africa is their relative low cost, particularly considering 
bars and clamps are often cleaned and re-used.  While union rates in large series were reported at 
94%, difficulty of closed reduction raises potential for higher rates of malunion, reported at 20% and 
33% in meta-analyses by Bhandari and Giannoudis, respectively.11, 13 
Intramedullary nails offer a similar union rate of 95% with the advantages of controlling 
segmental fractures (thus limiting malunion rates to approximately 10%), preserving joint motion, 
and permitting early weight bearing in polytrauma patients.  Relative disadvantages include longer 
operative time, higher implant costs, higher rates of implant failure (12.4% vs 2.4% for external 
fixation), and prevalence of post-operative anterior knee pain.  Rates of delayed union are somewhat 
equivocal between techniques, reported at 24% for external fixation and 22% for intramedullary 
nailing.  Deep infection rates for both techniques are highly variable, with reported rates for external 
fixation ranging from 5.7 to 16.2% while rates for intramedullary nailing range from 2.4% to 7%.10, 11 
When treating severe open tibial shaft fractures, most surgeons in HICs now employ a 
“damage control” approach which draws from the relative merits of both methodologies. This 
strategy involves the application of an external fixator to the traumatized limb during the initial phase 
of care, followed by planned conversion to intramedullary nailing after the patient has been fully 
resuscitated and the wound thoroughly debrided.   
Orthopaedic surgeons at MOI, and across Sub-Saharan Africa, are generally familiar with 
using both external fixation and intramedullary nailing techniques. However, there is little, if any, 
empiric evidence to guide the choice of treatment.  Often, the operative plan hinges not on the 
surgeon’s experience or clinical judgment, but on the cost and availability of surgical implants.  
Economic scarcity necessitates careful resource allocation.  Surgeons must often utilize external 
fixation for definitive care, rather than converting all patients initially managed with external fixators 
to intramedullary nails. The impact of other clinical factors, such as patient comorbidities, operative 
timing, availability of antibiotics, and surgeon competence remain unknown.  
Despite the high prevalence of injury and disability throughout Sub-Saharan Africa, Africans 
rarely benefit from peer-reviewed research.  In a recent review of articles published in four leading 
orthopaedic journals over three years, publications from Sub-Saharan Africa accounted for only 0.4% 
of the 3964 articles reviewed and 5.6% of the 265 articles with developing world authorship.14  
OREF has already begun the work of reversing this trend. This study proposal aims to build on the 
success of a collaborative research partnership made possible by previous OREF funding which 
examined plating versus intramedullary nailing of femoral shaft fractures.   
We propose to undertake a randomized, prospective trial which will generate Level 1 evidence 
concerning optimal fixation methods for the treatment of severe tibia fractures in Dar es Salaam, 
Tanzania.  Clinical and functional outcomes data obtained from our study will inform practice 
patterns of surgeons throughout Africa, helping to reduce patient morbidity, limiting the economic 
impact of injury, and minimizing health system expenditures by preventing complications which 

 
8 
 
 
 
 
would necessitate reoperation. Results would prove useful to orthopaedic surgeons worldwide, who 
would have the highest caliber scientific evidence with which to advocate for funding needed from 
policy-makers and charitable donors to address the growing epidemic of global extremity trauma.  
Perhaps more importantly, we hope to break the widely held perception that austere environments 
present unsurmountable challenges to meaningful clinical inquiry. 
 
2.3 Preliminary Data 
 
Our Tanzanian colleagues conducted a preliminary study with similar research design over 
12 months from March 2013 to February 2014.  Fifty-four patients with Gustilo and Anderson Type 
3A tibial shaft fractures were enrolled and randomly allocated to two treatment groups.  Twenty six 
were treated with definitive external fixation, and 28 were managed with intramedullary nailing.  Two 
patients were lost to follow-up from each group, leaving a total study population of 50 patients 
followed for 4.5 months. 
As previously stated, the most common mechanisms of injury included motorcycle collisions 
(75.8%) and motor vehicle collisions (20.4%), followed by bicycle accidents and falls from height 
(combined 3.8%).  Young men were most commonly affected.  More than 60% of patients were 
treated within 16 hours from injury and 98% were treated within 24 hours from time of injury. 
Patients were treated according to standard open fracture protocols and randomized to two 
treatment groups undergoing either intramedullary nailing or external fixation.   
We found no statistically significant difference in the rates of wound healing or incidence of 
deep infection (7.7% for IMN vs 12.5% for ex-fix). Twelve patients (46.2%) treated with external 
fixators developed superficial infection, none of which required implant removal.  We observed a 
significantly faster time to callus formation in the intramedullary nail group (average 8.15 +/- 2.5 
weeks, 92% at 10 weeks) when compared with the external fixation group (14.7 +/- 3.3 weeks, 25% 
at 10 weeks).  Patients treated with intramedullary nails attained full weight bearing earlier than pts 
treated with external fixators.  Malunion rates were also significantly lower in the intramedullary nail 
group, as two ex-fix patients (8.3%) were found to have significant post-operative limb length 
discrepancies and three (12.5%) were revised for angular or rotational malalignment, versus no 
malunions noted in the intramedullary nail group.  
In summary, 9 patients (37.5%) treated with external fixation required re-operation (2 for 
deep infection, 3 for malalignment, 4 for delayed union) versus one re-operation (3.8%) for patients 
treated with intramedullary nailing.  While early results from this pilot study predict a clinical 
advantage for intramedullary nailing over definitive external fixation, we feel the small sample size, 
limited follow-up, and lack of functional outcomes data warrant further empirical investigation.  Most 
importantly, this pilot study, conducted by a Tanzanian primary investigator, demonstrates the 
viability of success for completing a larger randomized, prospective clinical trial in Dar es Salaam, 
Tanzania.  
3. Specific Aims 
 
Study Objective: To determine the optimal management of severe open tibial fractures in Sub-
Saharan Africa in order to reduce long-term disability, limit the economic impact of injury, and avoid 
resource costs of reoperation.  
 
Specific Aims 
1) Compare the all-cause reoperation rate for AO/OTA Type 42 open tibial shaft fractures treated 
with initial intramedullary nailing versus external fixation at Muhimbili Orthopaedic Institute in Dar es 
Salaam, Tanzania. 

 
9 
 
 
 
 
2) Compare rates of secondary clinical endpoints including postoperative superficial and deep 
infection, clinical union, radiographic union, malunion, and health-related quality of life with 
minimum one year follow-up. 
3) Identify prognostic factors related to the patient, injury, or management protocol that impact the 
reoperation rate, return to work, and health-related quality of life.  
 
Study Null Hypothesis: There is no difference in the all-cause re-operation rate comparing reamed 
intramedullary nailing and external fixation for the initial treatment of OTA 42 Type 42 open tibia 
fractures 
4. Methods 
 
The proposed study will be a prospective, randomized trial conducted at Muhimbili 
Orthopaedic Institute (MOI) in Dar es Salaam, Tanzania. All skeletally mature patients presenting to 
the emergency department between December 2015 and December 2016 meeting inclusion criteria 
will be consented and enrolled in the study. Baseline clinical data will be obtained during enrollment. 
The patients will then undergo a standard wound debridement protocol (regardless of treatment 
arm) followed by intraoperative confirmation that the wound can be primarily closed. If so, the 
patient will be randomized using the REDCAP randomization module to one of two treatment arms: 
intramedullary nailing or external fixation. Primary and secondary outcomes will be measured 
prospectively during the postoperative period and at subsequent follow-up visits at 2wk, 6wk, 3mo, 
6mo, and 1yr (Sections 2.6 and 2.7). Serious adverse events that occur during the study will be 
presented to all co-investigators (Section 3.2). Interim analysis will be produced and reviewed by all 
co-investigators every 6 months, with a final report generated within three months of the trials end 
(Section 2.9 and 3.3). 
 
 

 
10 
 
 
 
 
 
Figure 1: Timeline for patient enrollment and data collection 
 
4.1 Outcomes 
 
The primary outcome for our study will be composite, all-cause reoperation within one year of 
definitive skeletal stabilization, excluding bedside irrigation and debridement for superficial pin tract 
infections or planned ex-fix removal.  The use of composite outcomes has been validated in a wide 
range of clinical trials.19  Primary events included in our composite outcome are detailed in the 
following table.  
A participant who undergoes conversion from ex-fix to nail within six weeks of surgery will be 
analyzed according to the initial treatment that was assigned by randomization.  Patients who 
undergo conversion from ex-fix to nail more than six weeks after the index procedure will be 
considered to have undergone a reoperation and will therefore count toward the primary outcome.  
Conversion from nail to ex-fix, regardless of time point, will be considered a primary outcome event. 
 
Primary Events 
 
Infection or hematoma 
Repeat incision and debridement or drainage for 
superficial or deep infection or hematoma 
following initial wound healing. 
Bone grafting 
Bone grafting for patients > 6 months from index 
surgery. Bone grafting will be considered after 6 
months in the case of delayed radiographic 
healing with > 2 months pain on attempted weight 
bearing. 
Implant conversion (e.g. Ex Fix to IM nail) or 
implant exchange (e.g. exchange nailing) 
Implant conversion or implante exchange > 6 
months from index surgery to facilitate union. 
Implant removal 
1) 
For construct failure with appropriate clinical 
indication (broken hardware, half-pin failure 
at bone/pin interface).  
2) 
Intramedullary nail removal to facilitate union. 
3) 
Intramedullary nail removal due to patient 
reported pain or local irritation 
 
Dynamization of intramedullary nail 
To facilitate healing > 6 months from index 
surgery. 
* Note: Auto-dynamization without clinical 
indication for removal of broken component will 
not be counted as a primary event. 
Osteotomy 
To correct malalignment 
Amputation 
For limb salvage failure 
 
Secondary clinical outcomes will include: 
 
1. Post-operative compartment syndrome. 
2. Superficial infection, as defined by CDC surveillance definitions, to include pin tract infections 
and cellulitis which resolves with use of antibiotics and local wound care.  
3. Deep infection, as defined by CDC surveillance definitions, to include deep abscess or 
osteomyelitis.  

 
11 
 
 
 
 
4. Clinical union of fracture healing will be assessed by absence of movement at fracture site and 
time to painless weight bearing.20  Non-union will be defined as fracture failure to heal beyond 
six months from date of injury. 
5. Radiographic union will be assessed using rate of callous formation and visibility of fracture line 
as measured by the RUST score.21 
6. Malunion.  Post-operative malalignment will be defined as leg length discrepancy (>1 cm 
shortening), angular malalignment (> 5 degrees sagittal or coronal angulation referenced 
contralateral leg radiographs, if non-injured), or malrotation (>10 degrees, determined by Foot-
Thigh Angle).  
7. Implant failure will be defined as breakage or loosening of any implant component at bone-
implant interface which necessitates re-operation.  
 
Secondary functional outcomes will include: 
 
1. Health-related quality of life as measured by EQ-5D. 
2. VAS pain score. 
3. Knee and ankle range of motion. 
4. Functional testing to include walking speed and ability to assume full crouch. 
 
4.2 Sample Size 
 
Data from two preliminary studies at MOI inform our projection for requisite statistical power.  
Our pilot study showed a difference in reoperation rate comparing external fixation and 
intramedullary nailing of 38% versus 3.8%, respectively.  However, with longer follow-up and more 
stringent criteria for reoperation, we estimate a more conservative effect size is needed for power 
analysis.  Therefore, to achieve 80% power (alpha=0.05) with a more conservative difference in the 
reoperation rate of 5% to 20%, the study would require 88 patients in each treatment group, or a 
total of 176 with completed follow up. 
During the six month period from January to June 2012, MOI surgeons treated 238 patients 
presenting with open tibia shaft fractures, 50% (119) of whom suffered Gustilo Type 3A injuries - an 
incidence of approximately 20 patients per month.  Our colleagues report the rate of open tibia 
fractures has continued to increase over the last two years and by current accounting, averages 25 
patients with Gustilo Type 3A injuries per month.  We therefore estimate an annual volume of 
approximately 300 qualifying injuries treated operatively at MOI.  Assuming the majority meet 
inclusion criteria and a capture rate of 80%, we anticipate enrolling approximately 240 patients over 
a one year collection period.  If the goal of 80% follow-up is met, a total of 192 patients will be 
included in our final analysis and we will achieve adequate statistical power.  We will plan to conduct 
an interim analysis after six months to assess the accuracy of these initial estimates and determine 
whether the duration of the enrollment period should be altered. 
4.3 Timeline 
 
November 2015:     
Training, refinement, and implementation of study protocol    
December 2015:       Begin study enrollment 
January 2016:  
1 month evaluation and consideration for protocol changes 
June 2016:            
Site visit for 6 month interim analysis and progress report   
December 2016:        End study enrollment and 1 year site visit/interim analysis/progress report 
June 2016:           
Site visit for 18 month interim analysis and progress report 
December 2017:   
Complete follow-up data collection 
March 2017:     
Final data analysis 

 
12 
 
 
 
 
5. Study Procedures 
 
5.1 Screening 
 
Screening for patients will begin on December 14, 2015 at 9am and end in approximately one year 
when the appropriate sample size has been reached. All open tibia fractures arriving at the MOI 
emergency room during the enrollment period will be screened for inclusion in the study. All patients, 
even those who are excluded, need to have their information recorded on REDCAP. 
The orthopedics department has been directed to call the study phone whenever an open tibia 
patient comes in. The research coordinator is required to keep the study phone close with them at all 
times.  
- 
If the patient arrives during normal business hours (7am to 5pm), the coordinator will go to 
the emergency room to assist the patient’s physician with screening. The coordinator is also 
expected to periodically check the emergency room for any new open tibia patients in case 
the emergency staff fail to contact the study phone. 
- 
The study coordinator on duty will remain at MOI until 9pm and periodically check the 
emergency room for any new open tibia admissions. If the patient arrives from 9pm to 11pm, 
the coordinator will screen from home using the study laptop. If the patient meets study 
inclusion/exclusion criteria, the coordinator will come to the hospital to consent the patient 
to enroll in the study.  
Inclusion Criteria 
1. Skeletal maturity 
2. AO/OTA 42 open tibia fractures * 
3. Wound primarily closeable (no flap or delay in closure due to contamination needed) 
4. Palpable pedal pulses (no vascular injury sustained) 
5. Presentation within 24 hours from injury ** 
 
Exclusion Criteria 
1. Current injury is a pathologic fracture 
2. Sustained bilateral tibia fracture 
3. Sustained comminuted femur fracture 
4. Sustained severe Traumatic Brain Injury (GCS<12) *** 
5. Sustained severe spinal cord injury (lower extremity paresis/paralysis) 
6. Sustained severe burns (>10% total body surface area (TBSA) or >5% TBSA with full 
thickness or circumferential injury) 
7. Prior ipsilateral leg injury requiring surgery 
8. Prior or current lower limb deformity or abnormality 
9. Unable to complete follow-up visits 
* See addendum for OTA42 subclassification schematic 
** Patients who present greater than 24 hours after injury and/or have non-primarily closeable 
wounds but meet all other criteria are eligible for the cohort study (see below 

 
13 
 
 
 
 
*** If at any point prior to the operation, the patients GCS score drops below 12, the patient will be 
excluded from the study. If the GCS score drops below 12 after the operation, the patient will remain 
in the study.  
Cohort Study 
Patients who meet all inclusion/exclusion criteria but present to MOI’s emergency room beyond 24 
hours after their injury and/or have non-primarily closeable wounds will be consented and included 
in a separate cohort study. These patients will be treated exactly the same way as an RCT patient 
with the same data collected except that they will not be randomized. Their primary surgeon will 
decide which operation is the most appropriate. The same consent form will be used, but the patient 
will be explained the details of the cohort study rather than the RCT study. 
Informed Consent 
All patients who remain eligible after clinical screening will be offered enrollment in the study.  A 
written informed consent document will be provided to the patient and reviewed in detail by a trained 
research coordinator.  This document will be provided in English or Swahili depending on the 
patient’s preference. In cases where the participant is unable to provide consent, consent will be 
obtained from a legally acceptable representative. If the participant is unable to read, verbal consent 
will be provided in the presence of an impartial witness. The consent document should be signed 
and dated by the individual providing consent as well as the participant or their legally acceptable 
representative.  
 
Signed consent forms should be kept in the SIGN Nail Office. A picture of the signature form should 
be taken and uploaded onto REDCAP.  
 
If there is any concern from either the patient and/or the research coordinator that the patient will 
be unlikely to complete any follow-up visits (especially the 1 year follow-up visit), that patient will be 
excluded from the study. If the patient does not provide consent for any other reason besides an 
inability to complete follow-up clinics, the reason for not providing consent will be recorded.  
 
Baseline Clinical Information 
 
Once a participant has completed informed consent, the research coordinator will obtain baseline 
clinical information and record the information in REDCAP. 
 
Antibiotics Administration 
 
Antibiotics must be administered as close to admission as possible to minimize the risk of infection. 
The standard study antibiotic regiment is based on the estimated level of contamination. This 
depends on the clinical history and a visual assessment of the wound. It is up to the discretion of the 
treating surgeon which antibiotic regiment the patient will be placed on. It is recommended that the 
surgeon utilize one of the three regiments, but in cases where there is a compelling reason for the 
use of a non-study regiment, the surgeon is allowed to place the patient on a non-study antibiotic. 
 
The breakdown of the antibiotic regiment only with details regarding whether or not the study will 
provide the antibiotics can be found below.  
 
Contamination Level 
Treatment 
Provision Status 
None or mild  
Ceftriaxone 1g every 24 hr for 2 days 
Provided for free 

 
14 
 
 
 
 
Moderate  
Ceftriaxone 1g every 24 hr for 2 days  
+ Gentamycin 80mg every 12 hr for 2 days 
First dose gentamycin provided for free. If the 
patient cannot or is unwilling to pay to 
complete the regiment, the full course will be 
provided for free 
Severe or high risk  
Ceftriaxone 1g every 24 hr for 2 days 
+ Gentamycin 80mg every 12 hr for 2 days 
+ Metronidazole 500mg every 8hr for 2 days 
First dose gentamycin and metronidazole 
provided for free. If the patient cannot or is 
unwilling to pay to complete the regiment, the 
full course will be provided for free 
For patients who receive additional operations as part of their care (such as definitive treatment 
following damage control or reoperations), the antibiotics will be provided according to the same 
system as detailed in the table above. 
 
There are three stages in the study where antibiotics can be administered: 
 
1. Admission to MOI: all study participants will receive antibiotics at admission. The type of 
antibiotic to administer is based on a visual assessment of the wound as well as the clinical 
history provided by the patient. The decision to provide antibiotics should be done 
immediately following consent by the patient. A standard study antibiotic regiment should be 
administered unless another antibiotic is believed to be more suitable for the situation. 
2. After surgical debridement: the study participant’s surgeon may order additional antibiotics 
to be administered after further evaluation of the wound during surgical debridement. These 
may be standard study antibiotics or can be any other antibiotic that is available in the OR 
and that the surgeon believes is more suitable for the situation. 
3. In the ward: the ward physician must continue the antibiotic regiments that have already 
been started in stages 1 and 2 and is also free to prescribe any additional antibiotics that 
may be necessary. These do not have to be from the standard study regiment. This applies 
primarily to patients who need to stay in the wards longer to recover from other associated 
wounds.  
 
A system of recording which antibiotics were administered at each of the three steps has been built 
into REDCAP. The surgeon is allowed to stop a course of antibiotics at any point during the patient’s 
treatment. If that is the case, the details of the situation will be recorded in REDCAP.  
 
5.2 Radiographs 
 
AP and lateral view x-rays should be taken at the following stages of the study: pre-op, post-op, 6 
weeks, 3 months, 6 months, and 1 year. Research coordinators should try to be with the patient 
while these x-rays are taken to ensure that images of adequate quality are taken.  
 
Radiographs are viewable through ClearCanvas enabled MOI desktops which are available in the 
radiology department, emergency department, and outpatient department. 
 
A picture of the radiographs should be taken and uploaded onto REDCAP. The name of the patient 
should be visible on the picture taken. A reviewer from UCSF will review the baseline and follow-up x-
rays within a reasonable timeframe after the pictures are uploaded. 
 
Preoperative x-rays will be assessed for fracture classification.  Follow up x-rays will be assessed for 
evidence of hardware failure and fracture union, as determined by the RUST score.  In cases of 
disagreement, the reviewers will meet and achieve consensus.  All data entry will be performed 
directly into REDCap. 
 

 
15 
 
 
 
 
5.3 Quality Control 
 
To ensure quality of the x-ray, the radiology department has been notified to make sure that the x-
rays include the fracture site and as much of the tibia as possible. For tall patients with long tibias, 
this may not be possible with the cassettes that are currently available for use by the department. If 
that is the case, 4 x-rays should be taken at each step of the patient’s care: proximal tibia AP and 
lateral views as well as distal tibia AP and lateral views. However, this should be avoided when 
possible to minimize radiation exposure to the patients. The cost of the extra x-rays will be covered 
by the study. An option to upload additional x-rays has been built into REDCAP.  
 
Post-op x-rays ideally are performed immediately after surgery. However, sometimes the x-ray 
department is backed up or the patient is uncooperative. If that is the case, try to notify the ward 
physician on duty to order the post-op x-rays. While it is under MOI policy that patients should not get 
discharged before getting post-op x-rays, sometimes this occurs immediately prior to discharge, 
making it difficult to ensure the quality of the x-ray. 
 
In situations where the post-op x ray is found to be inadequate but the patient has already been 
discharged, it is permissible to retake the x-ray at the 2nd week follow-up visit and consider those x-
rays as the control. While this situation is not ideal, it is an appropriate back-up option in case the 
immediate post-op x-rays are inadequate. 
 
For further information on x-ray quality control, refer to the addendum at the end of this document. 
 
5.4 Wound Measurement and Classification 
 
A measurement of the wound is to be done in the operating room. Specifically, it should be taken 
after the patient receives anesthesia and the temporary splint/bandages have been removed but 
just before surgical debridement. The wound should be measured using a centimeter ruler (rather 
than visually approximated) and recorded onto REDCAP. 
 
Only the maximum dimension of the wound (the longest length possible) needs to be recorded. This 
is irrespective of how the wound is oriented along the limb. The wound length should only include the 
part of the wound that is open (ignore any superficial abrasions that may be connected to the open 
part of the wound).  
 
OTA Wound Classification 
 
Classification of the wound is done using the OTA Wound Classification questionnaire (see REDCAP 
section).  Wound classification is to be done after surgical debridement which allows the surgeon to 
fully assess the wound.  
 
Wound Closure Status Check 
 
After surgical debridement, the surgeon will assess the wound to see if the wound can be primarily 
closed. If the wound can be primarily closed, the patient will continue with the RCT Study.  
 
If the wound cannot be primarily closed, the patient will be enrolled as a cohort study patient.  
 
If the wound is found to be primarily closeable and came to MOI within 24 hours of injury, the patient 
will be funneled into the RCT study and randomized  

 
16 
 
 
 
 
 
5.5 Damage Control 
 
After assessing the wound, the primary surgeon will need to determine if “damage control” using a 
temporary external fixator is necessary. This may be utilized in situations where the patient is 
hemodynamically unstable and needs quick stabilization of the tibia or requires another surgery that 
is more important. This option is available to the surgeon for both RCT and cohort patients. 
Furthermore, this option is available for RCT patients who are randomized to either a nail or an exfix.  
 
If the surgeon decides to perform damage control, a temporary external fixator will be placed, and 
the patient will be allowed to recover in the ward with the definitive operation performed at a later 
date. The date of both the temporary exfix placement and the definitive operation will be recorded 
onto REDCAP. There is no set time limit or criteria for how long the temporary external fixator should 
remain on before the definitive treatment is to be conducted. The only standardized policy is that the 
definitive operation should take place in a timely manner after the clinical issue that warranted the 
temporary external fixator in the first place has been resolved. 
 
5.6 Randomization 
 
The following information applies only to patients who are eligible and enrolled in the RCT study. For 
cohort study patients, the primary surgeon is responsible for deciding which surgery is the most 
appropriate for the patient. This includes either nail or exfix and the number of proximal and distal 
interlocks or schanz screws.  
 
After the surgeon has deemed that the patient’s wound can be primarily closed, the patient is ready 
to be randomized. Randomization will be done via the REDCAP module. The randomization allocation 
table utilizes a pseudo-random number generator from sealedenvelope.com and incorporates block 
randomization to maintain roughly equal distribution between the two groups throughout the study. 
The number of random allocations is set to 340 to account for additional patients beyond the 240 
that is expected to be enrolled.  
 
The patient will be randomized to receive either a hand-reamed SIGN intramedullary nail or locally 
available external fixator. Both modalities will be applied using standardized techniques. 
 
5.7 Definitive Treatment 
 
Nail: It is up to the surgeon’s discretion as to the appropriate size of the nail. A total of 4 screws will 
be placed – 2 proximal and 2 distal. These decisions will be recorded on REDCAP during the 
operation. 
 
Exfix: Two Schanz screws will be placed proximally and two will be placed distally; only a single bar 
will utilized. The patient will be instructed on proper pin-care procedures at the time of discharge 
which involves pouring methylated spirit (alcohol) directly onto the pins twice daily until the exfix is 
removed. The patient will be discharged with bandages covering the wound, but the pin insertion 
sites will be left open to allow for proper ventilation and pin-care. The patient will be discharged with 
dressing covering the wound and pin sites. The exfix will remain on for 3 months. At the 3 month 
follow-up, the decision will be made to (1) remove ex-fix, (2) remove ex-fix and replace with cast, (3) 
delay exfix removal, or (4) other. Delayed removal or other will be submitted for adjudication review.  

 
17 
 
 
 
 
 
Wound Protocol 
 
If the wound is dry at the 2 week wound check, the dressing will be removed. If the wound is still wet 
at 2 weeks, the dressing will be changed and the patient will be instructed to peridiodically revisit the 
hospital to change the dressing until the wound becomes dry. 
 
Weight Bearing Protocol 
 
All patients will be advised to be on toe-touch status for the first 6 weeks. Afterwards, the patient will 
be instructed to bear weight as permitted by pain.  
 
Summary of Treatment Options 
 
Primarily closeable? 
-> 
No 
 
 
 
 
->  
Cohort Study 
 
 
 
->  
Yes (Cohort) 
(+ damage control) 
->  
Temporary exfix 
 
 
 
-> 
Yes (Cohort) 
(no damage control) 
-> 
Definitive operation 
 
 
 
-> 
Yes (RCT): Nail  (+ damage control) 
->  
Temp exfix (then nail) 
 
 
 
-> 
Yes (RCT): Exfix (+ damage control) 
-> 
Temp exfix (then exfix) 
 
 
 
-> 
Yes (RCT): Nail (no damage control) 
-> 
Nail now 
 
 
 
-> 
Yes (RCT): Exfix (no damage control) 
-> 
Exfix now 
 
 
5.8 Follow-up Schedule 
 
Participants will be scheduled for follow up appointments at 2 weeks, 6 weeks, 3 months, 6 months, 
and 1 year after the date of surgery. The 2 week visit is primarily a wound check to assess the wound 
and record any other surgical or medical complications that may have arisen since discharge. The 
remaining follow up appointments will include clinical evaluation, plain radiographs (AP and lateral 
views), and administration of the EQ-5D. The follow up schedule will be generated using the 
scheduling function in REDCap. All research clinic appointments will be conducted in a dedicated 
research clinic on Saturday afternoons.  Every research clinic will be staffed by one of the study 
investigators (BH, EE), at least one research coordinator, and a research nurse.   
 
Because the follow-up clinics occur on Saturdays, the following rounding system will be used to 
calculate which date the patient should come for a follow up visit: 
 
- 
For patients that get operated on a Sunday, Monday, or Tuesday, the previous Saturday will 
be used to calculate the 2 week follow up date (and all other subsequent dates) 
- 
For patients that get operated on a Wednesday, Thursday, Friday, or Saturday, the upcoming 
Saturday will be used to calculate the 2 week follow-up date (and all other subsequent dates) 
 
Promoting Follow Up 
 
The following strategies will be implemented in order to improve the rate of follow up: 
 
1. Treating patients with a high level of hospital which involves: 
a. Introducing the study participant to all members of the team 
b. Advocating for timely and appropriate care of the patient 
c. Clearly informing the patient about the steps of the study 
d. Explaining the study to the contacts that the patient provided 

 
18 
 
 
 
 
e. Protecting patient confidentiality 
2. Calling the 3 contacts that the patient provides at the time of enrollment and notifying them 
of the patients illness, their participation in the study, and the importance of helping them 
attend all follow-up visits. 
3. Costs of follow up care will be free to study participants, including the consultation fees and 
cost of plain x-rays.  
4. Saturday clinic will be separate from the general clinic and conducted in private clinic offices.  
This will make it easier for patients to come back to MOI, minimize waiting times, and ensure 
patients are able to see a specialist rather than physician in training.   
5. All patients will be contacted on the Wednesday prior to the Saturday clinic by phone as a 
reminder of the appointment time.  A second reminder will be sent by text message on the 
day prior to the clinic.  
 
No cash incentives will be provided to compensate for travel and other expenses.    However, at the 
conclusion of 1 year, all patients who have been lost to follow up will be contacted by study staff to 
encourage return to the clinic.  In cases where cost of travel is the principal barrier, a telephone 
follow-up evaluation will be conducted. The patient will also be asked to go to the nearest hospital, 
take follow-up x rays, and send in a picture of the x-rays. A picture of the patient performing the squat 
and smile test will also be requested. 
 
5. 9 Study Financial Coverage 
 
The following summarizes what is and what is not financially covered by the study. Any items not 
mentioned here need to be approved by the study review committee.  
 
Covered 
Not Covered 
- 
Ceftriaxone on admission 
- 
Ceftriaxone on subsequent surgeries 
that occur during the patient’s first stay 
at the hospital 
- 
First dose of gentamycin * 
- 
First dose of metronidazole * 
- 
Consultation fees for follow-up clinics 
- 
Follow-up x ray images at 6k, 3mo, 
6mo, 1yr 
- 
2 week post-op control x-ray redo (if 
necessary) 
- 
Admission consultation and pre-op time 
- 
Cost of surgeries, implants ** 
- 
Post-op time in ward 
- 
Reoperations and all associated 
antibiotics and medications** 
- 
Exfix pin care methylated spirit 
- 
Knee brace 
- 
Physical therapy 
 
* If the patient is not able to afford the remaining doses or has no relative who can purchase the 
antibiotics or will not be able to purchase the antibiotics in a timely fashion, these antibiotics will be 
provided for the patient at no extra cost 
** While the study will not cover these items, the hospital may cover the cost if the patient is not 
able to afford  
 
 
Study Steering Committee 
 
The steering committee for the study will consist of David Shearer, Saam Morshed, Billy Haonga, and 
Edmund Eliezer.  The steering committee will be responsible for performing adjudication review, 
evaluating interim data, and approving any sub-projects.  

 
19 
 
 
 
 
5.10 Adjudication Review 
 
Review of the following study events will require review from the members of the study steering 
committee: 
 
1. Death of a patient 
2. Delayed external fixation removal 
3. Surgical complications requiring reoperation 
 
The review, comment, and voting process will occur on REDCAP. 3 steering members will need to 
evaluate each event that is put up for review. The steering committee members are responsible for 
providing the following inputs for each event: 
 
1. Comments/opinions/justifications 
2. Vote (yes or no): question varies depending on the event 
a. Death event: question not applicable 
b. Delayed external fixation: does the patient need to remain on external fixator for an 
extended length of time? 
c. Surgical complications requiring reoperation: does the patient need a reoperation? 
3. Vote (yes or no): is this event a primary outcome of the study? 
 
Adjudication review will be conducted every 2 months. 
 
Final Reporting 
 
At the conclusion of the study there will be a principal manuscript reporting the findings of the 
primary study endpoints. 
 
On-Duty Schedule and Responsibilities 
 
A research coordinator is required to be on duty at all times. A person will remain on-duty for three 
consecutive days. The transition to the next person on duty will occur at noon or in the early 
afternoon after the person on-duty has finished the morning tasks. During the transfer, the person on 
duty should notify the next person on duty about any pending items that need to be completed. 
These items should be written down in the on-duty diary.  
Scheduling of the person on duty is to be done on an excel form available in the dropbox. 
Substitutions are permitted as necessary. The form is to be maintained and updated should any 
substitutions occur.  
The following need to be provided for the on-duty coordinator: 
□  Study Laptop and USB Modem 
□  Study Phone 
□  Battery charge bank and wire 
□  On-call diary  
□  SIGN office key 
□  Antibiotics 
□  Wound measurement ruler 
□  On-duty diary 

 
20 
 
 
 
 
□  Extra forms: consent, OTA wound classification, EQ-5D 
 
Daily tasks for on-duty 
 
To do in the morning: 
 
□ Patients in ward: (1) create follow-up schedule and (2) make sure they receive their 
antibiotics 
□ Patients in emergency: periodically check to see if there are any new patients 
□ Check in emergency logbook if there were any missed patients 
□ Patients waiting for operation: wait and randomize in OR 
□ Get the unused antibiotics from emergency room from last night 
□ Fill in on-duty diary 
 
To do at night before leaving: 
□ Check for any new tibia patients 
□ Leave ceftriaxone (3 boxes and 3 waters for injection) for emergency 
□ Instruct emergency staff about the purpose of the antibiotics  
□ Remind emergency staff to contact the study phone for any open tibia patients  
□ Upload any images such as consent forms, radiographs, etc. 
 
Tasks specific to the person on duty on Wednesday: 
□ Call patients scheduled to come for follow-up clinic on upcoming Saturday  
- If appointment confirmed with patient, go to calendar in REDCAP and change 
appointment status to “Scheduled” 
- If not scheduled, call repeatedly during the week until they are aware of the 
appointment 
□ Send text reminder to all patients on Friday* 
 
* This duty falls on the person on duty on Wednesday because that person is most familiar with the 
patients who will come on that Saturday 
 
 
Tasks specific to the person on duty on Saturday: 
□ Prepare records of patients for Saturday Clinic 
□ Contact the physicians that should be present at Saturday Clinic 
□ Manage Saturday Clinic 
□ Send review committee an email notification regarding the events that have occurred that 
need to be reviewed 
 
To do whenever a new patient enrolls in the study: 
1. Record details on REDCAp 
2. Ensure antibiotics are given promptly 
3. Assess quality of pre-op x-ray and redo if necessary 
4. Call 3 phone numbers and notify patient contacts of the study 
 
When calling patients to remind them of their follow-up clinic, please notify them of the following: 
□ The clinic is entirely free 
□ It is important for them to attend the clinic to ensure their recovery is properly managed 
□ It is important for them to come to clinic even if they feel normal and healthy 
□ If they have not yet finished paying their hospital bill, we will not force them to pay their bill 
 

 
21 
 
 
 
 
After discharge, patient records go to the accounts department so that the patient can complete 
their bill. The records should be received from the accounts department after the bill has been paid. 
The records should then be stored in the SIGN Nail Office until the completion of the study.  
6. REDCAP Procedures 
 
General Principles 
• 
All dates are to be recorded in the format dd-mm-yyyy.  
• 
A new record is only created when data is saved into that record 
• 
A new form is created only when data is saved into that form 
• 
**This is a key study question  
Adding a New Record 
A record is the same as a study participant. The Participant ID will be automatically generated by the 
REDCAP system in ascending numerical order. REDCAP does not allow you to change or manually 
input the participant ID.  
1. Click on “Add/Edit Records” on the left panel 
 
2. Click “Add new record” 
 
Editing an Existing Record 
1. Click on “Add/Edit Records” on the left panel 
 
2. Click on the drop down menu and select the desired record. Wait for the record to load.  
 
6.1 Enrollment form – Screening and Consent 
 

 
22 
 
 
 
 
All open tibias will be screened during the enrollment study of the period. All included patients will be 
recorded in the same project and treatment arm on REDCAP regardless of whether or not they are in 
the RCT or Cohort study. Even those that will be excluded need to be reported on REDCAP.   
1. Add a new record 
2. Record Date of Screening, MRN, and First/Middle/Last Name 
a. MRN is to be in the format BXXXXXXXX as in all MRNs need to be led by a “B” 
followed by the appropriate number of blank zeroes. This is to maintain consistency 
with the MOI EMR and Clear Canvas 
b. The first letter of each name should be capitalized 
 
The next steps involve screening the patient for the appropriate inclusion/exclusion criteria. These 
should be performed with assistance from the patient’s surgeon. 
3. Fill in inclusion criteria 
a. Question1: OTA 42 refers to diaphyseal (mid-shaft) tibia fracture which must be 
confirmed by radiographic imaging 
b. Question 2: Pedal pulses palpable is a clinical finding that confirms that the patient’s 
vascular system is intact 
c. Question 3: Presentation time to MOI is defined as the time that they arrived at MOI’s 
emergency room (not Muhimbili National Hospital EMD) 
d. Question 4: Skeletal mature is defined by closed physis as seen on radiographic 
imaging 
e. Question 5: Primarily closable wound means that the skin is intact and that the 
contamination level is low enough for the patient’s wound to be fully closed at the 
time of surgery. 

 
23 
 
 
 
 
 
4. Fill in Exclusion Criteria 
a. Question 1: Pathologic fracture means a fracture which is due to weakening of the 
bone caused by an underlying bone disorder such as a tumor or osteoporosis.  
b. Question 2: Bilateral (meaning both legs) tibia fractures are excluded due to the 
difficulty in randomizing a patient with two open fractures and also the potential 
negative influence on outcomes that having two tibia fractures cause 
c. Question 3: GCS stands for Glasgow Coma Score. It is a rapid way to assess 
neurologic function. GCS < 12 means impaired cognitive function. 
d. Question 4: Paralysis means inability to use a particular body part 
e. Question 5: TBSA stands for Total Body Surface Area. Burns are calculated by 
assessing the percent of the skin they cover. 
f. 
Question 6: Prior ipsilateral leg injury means a previous injury in the same leg 
g. Question 7: This question is to rule out patients with physical or function leg 
deformities  
 

 
24 
 
 
 
 
At the end of answering these questions, an automated message will be generated based on the 
answers provided.  
5. Observe automated eligibility message 
- 
If all inclusion criteria are answer as “yes” and all exclusion criteria are answered as “no”, 
the patient is eligible for the RCT 
- 
If the patient (1) came to MOI 24 hours after injury, (2) has a non-primarily closeable wound, 
or (3) came to MOI 24 hours after injury AND has a non-primarily closeable wound, the 
patient will be eligible for the cohort study. 
- 
All other responses will result in exclusion for the study.  
 
6. In situations where a patient is excluded for a particular reason, the only information that 
needs to be filled out on the screening form is the patients MRN, full name, and the one 
reason why the patient is excluded. It is not necessary to go through the other screening 
criteria if one criteria for certain excludes the patient. For excluded patients, a pop up box will 
appear. Record the exact reason for exclusion here.  
 
7. Next, record whether or not the patient consents to the study.  
a. If there is concern that the patient will not be able to be contacted for the 1 year 
follow-up visit, please choose that option. Note that this is one of the exclusion 
criteria.  
b. If the patient is able to attend the follow-up visits but does not agree to participate in 
the study for any other reason, click “No” and record the reason why. It is important 
to record the reason why so that the study team can identify consistent reasons for 
not participating in the study. 
c. If the patient provides consent, click “Yes” and confirm the study that the patient is 
enrolled in. This should match the study that the system automatically calculated. If it 
does not match, warning messages will pop up. Double check the screening 
questions to make sur the patient is enrolled in the correct study 
d. If the patient was not identified before their operation but later found to have been 
eligible, record “missed patient” 
 

 
25 
 
 
 
 
 
Enrollment Form - Baseline Clinic Information 
1. Record demographic information 
a. If the exact date of birth down to the date cannot be provided, leave that field as 
empty and record in the text box an estimate of how old the patient is. When the 
patient’s relatives come, please ask them for the exact date of birth 
b. “Number of people in household” refers to the number of people the person shares a 
room/apartment/house with. These people may or may not be family members 
c. “Number of people patient financially supports” refers to number of people the 
patient helps financially. These may or may not be family members 
d. Insurance status refers to the type of insurance the patient has. If the patient buys 
insurance from a private company, check “Private”. If the insurance the patient has is 
provided by the government, check “Public”. 

 
26 
 
 
 
 
 
2. Ask about work status 
a. “Formal Employment” refers to an official job with a contract such as a salaried 
health records technician at MOI. “Informal Employment” refers to people like boda 
boda drivers, etc. 
3. Past Medical and Social History 
a. Please individual ask the questions provided. Do not just say “do you have any other 
health problems”; if asked in this way, patients are more likely to forget to mention 
something 
b. CD4 count refers to a lab test often given to people with HIV to check on their health 
status. Patients may or may not have been tested. 
c. Smoking is a particularly important question because many studies on infection rates 
following open fracture repair cite smoking status as one of the contributors to an 
infection after surgery.  

 
27 
 
 
 
 
 
 
4.  

 
28 
 
 
 
 
 
5. Injury Characteristics 
a. “Date and Time of Presentation to MOI” refers to the time they arrive at MOI’s 
emergency room, not Muhimbili National Hospital emergency room 
b. “Outside Hospital” refers to any other hospital besides the hospitals in the Muhimbili 
Complex 
c. “Fall from standing height” means the patient was standing on the floor and then fell 
onto the floor (as in they did not fall off a roof) 

 
29 
 
 
 
 
 
 
6. EQ-5D at Baseline 
a. The EQ-5D questions at this step of the study refer to the patient’s health status just 
before the injury 
b. It is best to provide all the answer choices to the patient before allowing the patient 
to make a choice. This is how the original EQ-5D in English is tested and validated, 
and we should try to perform the EQ-5D as close as possible to the original way in 
which it was performed 

 
30 
 
 
 
 
 
7. Contact Information 
a. We will record at minimum 3 phone numbers. The first one will most likely be the 
patient’s own phone number. Additional phone numbers can either be other phone 
numbers that the patient has or friends/relatives 
b. In the “Relationship to patient” question, a text box has been provided. Enter any 
description that will be useful when contacting that person such as “brother in law”. 
c. After collecting 3 phone numbers, call the numbers and inform the people you call of 
the patient’s injury and of their participation in the study. Also mention the 
importance of helping the patient attend all follow-up clinics. This is to encourage the 
contacts to take part in the patient’s care and help them remember to attend the 
clinics. 

 
31 
 
 
 
 
 
8. Additional contact 
a. In situations where there is concern that the patient may be lost to follow-up, record 
additional phone numbers as back-up. 
b. “Describe where you live” is a free text box. Provide as much detail as possible so 
that it may be possible to find the patient later on if the phone numbers no longer 
work and they are lost to follow-up. 
 

 
32 
 
 
 
 
 
9. Antibiotics 
a. Once the patient has provided consent to participate in the study, they should receive 
antibiotics as quickly as possible if they have not yet. 
b. If the patient received antibiotics at another hospital but then came to MOI and was 
changed onto a study antibiotic regiment, choose “other” and record the details of all 
antibiotics given since the time of injury 
 

 
33 
 
 
 
 
10. Tetanus prophylaxis 
a. All patients should have tetanus prophylaxis. This is usually in the form of a shot 
given in childhood with repeated shots every few years. If the patient does not 
remember or knows they have never received a tetanus shot, work with the National 
Hospital Emergency physicians to ensure the patients get the shot as soon as 
possible. This is most important for the patient’s health, but also important for the 
study.  
b. Ward number refers to the ward that the patient will be sent to after the operation. 
This depends on the patient’s insurance status. 
 
6.2 Intra-operative/Discharge Form 
 
This form applies to both RCT and cohort patients. But for cohort patients, the randomization module 
will not appear. 
1. Wound measurement 
a. A measurement of the wound should be performed after the patient receives pain 
medication and after all bandages and dressings have been removed. Take the 
maximum dimension of the portion that is open, ignoring superficial abrasions 
b. The measurement should be done in centimeters using a ruler rather than visually 
approximated. Be as precise with the measurement as possible 
2. Surgical Debridement and Primary Closure status 
a. Whether or not the surgeon believes the wound can be primarily closed is done after 
surgical debridement. They will clean up the wound, manipulate the fracture, and see 
if there is enough skin to close the wound.  
b. If the surgeon believes the patient can be primarily closed, the patient passes the 
last exclusion criteria check and should remain in the study. If it is a cohort patient, it 
is up to the surgeon which operation the patient receives. If it is an RCT patient, 
proceed to the randomization module 
 
 

 
34 
 
 
 
 
c. If the surgeon believes the wound is not primarily closeable, the patient needs to be 
excluded from the study. This is considered an “intra-operative exclusion”. This is 
what the warning message looks like: 
 
3. Randomization (RCT ONLY) 
a. If the patient is a cohort patient, the following reminder message will appear 
indicating the randomization module is hidden for these patient 
 
 
 
b. For RCT patients, this is what the randomization module appears like. Click on 
randomize, confirm the warning message, and randomize the patient. The 
randomization module results are final. Once randomization has been performed, the 
patient must remain in the study and must receive that operation 
 
4. Damage Control  
a. If the patient believes that damage control using a temporary external fixator should 
be performed before the definitive operation that the patient has been randomized to 
(in the case of RCT patients) or that the surgeon has decided (in the case of cohort 
patients), then record “Yes”. Damage control is usually done in situations where the 
patient is not hemodynamically stable enough for a full surgery, but it is still better to 
temporarily fixate the fracture using an exfix.  

 
35 
 
 
 
 
 
5. At this time, additional antibiotics can be added or removed depending on how much 
contamination the surgeon believes there to be inside the wound 
 
6. Wound Characteristics 
a. Record the wound measurement details here in centimeters 
b. OTA wound classification performed by surgeon  

 
36 
 
 
 
 
 
6. 3 Baseline Image Upload 
 
Oftentimes, there are differences in how the patient’s registration information is registered into the 
system. If it is not possible to find a patient using his last name, try using the middle or first names or 
using different spellings. It is also possible to search by MRN or date of x-ray. It is standard policy at 
MOI that all patients who will get operated at MOI receive x-ray imaging prior to and after the 
operation. This applies even if the patient arrives at MOI with x-rays taken at another hospital. 
Therefore, the x-rays should be in the system even if it is difficult to find the x-rays on the computer. 
Try different search criteria. 
 
It is also of note that desktops in the radiology department immediately adjacent to the x-ray 
machine which are connected to the machines that digitally scan the x-rays have their images erased 
on a regular basis. ClearCanvas, however, stores the images on a server indefinitely. 
 
If the x-rays need to be redone, a note should be made in REDCAP 
 

 
37 
 
 
 
 
1. The consent form, pre-op x rays, and post-op x-rays should be uploaded as soon as they are 
available.  
a. There is an option to upload extra images if they are available. Check on the Extra 
Image #, describe the image, and upload it by pressing on the “Upload document” 
link 
b. Upload any extra images that may be useful for UCSF during review 
 
2. The following questions will be used to evaluate the images at baseline 
a. While the option “X-rays not adequate” has been provided, please refrain from using 
this answer choice as much as possible in order to maximize the amount of data 
obtained from the images. 

 
38 
 
 
 
 
 

 
39 
 
 
 
 
 
 
6.4 Post-Op Discharge 
 
This form is to be filled out the morning after the patient’s operation. This information is to be found 
in the patient’s record which will be with the nurses in the ward. 
1. Temporary Fixation using Damage Control 

 
40 
 
 
 
 
a. Report whether or not temporary fixation was performed. If there is a mismatch 
between what was said about temporary fixation in the Intra-op/Randomize Form, 
warning messages will occur asking you to double check your answer. 
b. Note that if temporary fixation was not performed, the option to record the date of 
temporary fixation will not appear. 
 
2. Date of definitive treatment 
a. This is a critical study question because the reports for follow-up visits is based on 
this question 
b. If there is a mismatch between the type of definitive option stated in this form and 
what the patient was randomized to, a warning message will appear 
c. The size of the interlocking screws does not have to be recorded.  

 
41 
 
 
 
 
 
3. Operation duration times can be found in the patient’s record. These have been recorded 
during the operation 
 
4. Associated Orthopaedic Injuries and Injury Severity Score 
a. Review the information in the patient’s record and note any other injuries that the 
patient has besides the open tibia fracture. If there are other injuries, check yes for 
the appropriate injury classification. A text box will appear. Record what the physician 
wrote word for word. It is best not to interpret what the doctor said.  
b. If there is something you see that the patient has but the physician did not record the 
associated injury, notify the physician to confirm. If the physician agrees, record the 
information in the patient’s record first, then record in REDCAP. 
c. “Ipsilateral” means the same side of the body. “Contralateral” means the opposite 
side of the body. If a patient has a tibia fracture on the left leg, contralateral limb 
injuries refer to injuries on the right leg or arm 

 
42 
 
 
 
 
d. The Injury Severity Score uses a formula that turns diagnoses into a severity, and 
calculates the score over the entire body. It is an overall measure of the patient’s 
health after an injury.  
 
 
5. Antibiotics Check 
a. Record any additional antibiotics that were given in the ward and whether or not all 
the courses of antibiotics the patient was started on were properly completed (all 
doses were given on time) 

 
43 
 
 
 
 
 
b. Pin care information should be given to patients who have an exfix. The protocol is to 
pour methylated spirited onto the pin 2x a day 
 
6.5 Follow-up Evaluation Form 

 
44 
 
 
 
 
This form is intended for use at all of the follow-up evaluations. These evaluations can be the 
Saturday in-person clinics or the ones done over the telephone in situations where the patient 
cannot come to clinic.  
1. Follow-up visit number and type 
a. “Which follow-up evaluation?”: Even though REDCAP automatically generates a new 
Follow-up Evaluation form at each evaluation time point, this form asks again what 
evaluation visit number this form is for. This is important because the questions for a 
2 week visit are different from the 6week to 1 year follow-up visit.  
b. It is important to properly answer the “Type of Follow-up Evaluation” question 
properly because what you say determines the types of questions that appear. 
Certain questions such as Range of Motion evaluation can only be answer in person. 
 
2. Work 

 
45 
 
 
 
 
 
3. Pain assessment 
a. 10 is always worst imaginable pain. 0 is always no pain. 
b. The Tegner-Lysholm Knee Scoring System questions will appear only for patients who 
report anterior knee pain. It is best to read out the answer choices for the patient 
rather than asking them to provide the answer and interpreting their response. While 
some of the questions repeat questions that have already been asked, the knee 
scoring system needs to be completed in its entirety in order for a score to be 
calculated from the responses the patient provides. 

 
46 
 
 
 
 
 

 
47 
 
 
 
 
 
4. Imaging and Functional Testing 
a. These questions all require physical examination by the patient’s surgeon. These 
questions do not appear for patients who are being evaluated over the telephone 
b. A squat and smile test will be conducted like in the femur study. Be sure to upload 
the image with a clear view of the entire body during the test. 

 
48 
 
 
 
 
 

 
49 
 
 
 
 
 
c. The walking test will be administered according to the NIH 4 Meter Walking Test 
guidelines. Two tests will be conducted, and REDCAP will automatically calculate the 
average. Directions can be found online at the following link:  
http://www.nihtoolbox.org/WhatAndWhy/Motor/Locomotion/Pages/NIH-Toolbox-4--
Meter-Walk-Gait-Speed-Test.aspx  
 
5. Complications 
a. Properly recording complications is critical for the study because our end goal is to 
compare complication and reoperation rates between the two groups. 
b. Exfix patients will have additional questions appear related to schanz pin tract 
infections 

 
50 
 
 
 
 
 
c. If the patient has a medical or surgical complication, record “Yes” and proceed to the 
“Complications and Review” form. That is where additional information will be 
recorded. 
i. A pop-up warning will appear if a patient has had a complication recorded 
and is coming back for follow-up. This is to enable us to be up to date with 
complications. 
 

 
51 
 
 
 
 
6.6 Complications and Review Form 
 
This form is to be used to record all complications that occur in a patient throughout the entire time 
that the patient is in the study. There is only one form per patient (the form does not repeat). It can 
be used for complications that are caught during a follow-up Saturday clinic or when a patient 
reports a complication outside of a clinic. 
1. Notes on how to use this form 
a. The most important thing is to never uncheck an Event # checkbox that already has 
information stored in it. If this is done, a warning message will appear asking you if 
you want to delete the information or note. Press “OK” if your intention is to delete 
the information. If it was an accident, press “CANCEL” and then check the box that 
you accidentally unchecked. If any information is lost, leave the form and press 
“Leave and do not save record” when the warning message appears.  If any 
information was accidentally deleted, please tell Max. He may have a backup of the 
data if the data was not reported very recently. If he does not have a backup, he may 
be able to contact REDCAP or UCSF to retrieve the data. 
 
 
 
2. Overview 
a. Whenever a new complication needs to be reported, check the appropriate checkbox 
in order to open the questions where information can be recorded. It is important to 
note that Event #2 does not refer to “report two events”, it refers to “report the 
second event”. 

 
52 
 
 
 
 
b. Delayed exfix removal has its own types of questions and is listed separately. This is 
only for patients on exfix who need to stay on the exfix longer than 3 months. 
 
3. Mortality 
a. To be used only if the patient has died 
b. A query needs to be opened (See “Adjudication Review” Section) 
4. Medical Complications 
a. The most important thing to record for medical complications is whether or not the 
patient needed to be hospitalized.  
b. Medical complications do not be reported unless there is concern that needs to be 
reviewed by the review committee 
c. Any additional medical problems beyond 2 events need to be reported in free text 
entry in a text box. Number the medical complication events accordingly (Event #3…) 

 
53 
 
 
 
 
 
 
5. Surgical Complications 
a. If a surgical complication requires reoperation, record the estimated date and press 
“No” if the reoperation has not occurred yet. Patients who are awaiting reoperation 
will appear on the “Awaiting Reoperation” report.  
i. Record “no” for the question “has this been reviewed yet”. This will cause the 
complication to appear on the “Adjudication Review” report. Once the item 

 
54 
 
 
 
 
has been reviewed, Max will record “yes” which will remove the complication 
from the report. 
b. Once the patient has had their reoperation, change the answer to “Yes” and record 
the actual date of the reoperation. 
 

 
55 
 
 
 
 
 
 
c. Additional surgical complications beyond the third event should be recorded in free 
text entry box. Label the event # accordingly (Event #4…) 

 
56 
 
 
 
 
 
6. Delayed exfix removal 
a. For patients who need to stay on exfix for longer 
 
6.7 Follow-up Image Upload/Eval Form 
The same procedure for baseline evaluation images will be used for follow-up evaluation images. 
Note that if a patient is reported to not be able to perform the squat and smile and/or heel lift test, a 
flag will appear and the option to upload an image will not be present. 

 
57 
 
 
 
 
 
1. The following questions are used for image evaluation 

 
58 
 
 
 
 
 
2. The RUST Score questions will be used to evaluate quality of fracture healing 

 
59 
 
 
 
 
 
 
6.8 Follow-up Scheduling 
 
Patients should be scheduled for follow-up using the REDCAP scheduling module 
1. To generate the follow up schedule for the patient, click the “Scheduling” Link.  To create 
a second viewing window, right-click “Scheduling” and choose “Open in new tab”. This 
will allow you to remain in the participant’s record and edit the schedule at the same 
time 
2. Choose the “Create Schedule” tab 
3. Choose the participant ID 
a. If a patient does not have a schedule yet, they will appear on this list. If the 
patient has already been scheduled, they will appear on the list available under 
the “View or Edit Schedule” Tab 

 
60 
 
 
 
 
 
 
 
 
 
1. Choose the “Start Date”.  This depends on the patient’s date of operation. If the patient was 
operated on Sunday, Monday, or Tuesday, use the closest Saturday before the operation. If 
the patient was operated on a Wednesday, Thursday, or Friday, us the next closest Saturday. 
2. Click “Generate Schedule” 
 

 
61 
 
 
 
 
 
 
a. Delete the first line which is the “Enroll” Event 
b. If a patient knows they cannot come in on a particular Saturday ahead of time, you can 
manually change the follow-up date. This date must occur within a set range of dates. 
The allowed limits are found below. It is possible but not preferred to schedule a 
Saturday clinic outside of the allowed range. 
 
3. You must remember to Save the schedule by choosing “Create Schedule” 

 
62 
 
 
 
 
 
4. It is possible to view the schedule you have created for a patient by clicking on the “View or 
Edit Schedule” tab. Choose the patient’s record. 
a. If a schedule has not yet been created, they will not appear on this list. Instead, they 
will be found under the list in the “Create Schedule” Tab 
 
 
b. Note that the dates of the visits are reported in mm/dd/yyyy 
c. If the date of a scheduled visit needs to be changed, click on the pencil icon and 
select the new date.  
d. If a new follow-up visit event needs to be created, click on the “Add new Ad Hoc 
calender event on mm/dd/yyyy”. The date is reported in mm/dd/yyyy (American 
style) 
e. If the schedule needs to be erased completely, click on the X for each event to delete 
the event. After all events are deleted, the patient will appear in the list in the “Create 

 
63 
 
 
 
 
Schedule” tab (as in the patient will no longer have a schedule). From there, you can 
create an entirely new schedule. They will no longer appear in the “View/Edit Existing 
Schedule” tab 
 
Using the Calendar 
 
1. Open the calendar from the left-side menu 
a. You may view the calendar by day, week, or month.  Alternatively, you can choose 
agenda to see a listing of all appointments for the month.   

 
64 
 
 
 
 
 
2) On the Wednesday prior to each follow up clinic, open the calendar  
a. Choose the “month” tab 
b. Click the patient’s participant ID for those that are coming in that Saturday to open 
the appointment window.   
c. After calling the patient, change the status from “Due Date” to “Scheduled”. All 
successfully scheduled clinics will appear on the calendar as a yellow star. A white 
star means the patient has not yet been scheduled.  
 
3) After the patient’s visit has successful completed, change the appointment status to 
“Confirmed”, indicating that the visit has finished. These events will now appear as a green 
checkmark 

 
65 
 
 
 
 
 
 
6.9 Uploading Images 
 
There are two ways to upload photos/images onto REDCAP. The first and easiest is to connect the 
phone to a laptop and upload onto the REDCAP website. The second is to use the REDCAP mobile 
app. Both will be mentioned here in case one modality no longer functions. In both situations, after 
the file has been successfully uploaded, the name and size of the file will appear in the upload 
document field. If you need to change the uploaded file, press “Remove file” and upload the other 
file. 
 
Method 1 – Connecting Phone to Laptop 
1. Take photo using phone 
2. Connect photo using laptop 
3. Open the patient’s REDCAP form and press “Upload Document”  
4. Navigate to the phone’s memory, select the photo, and upload the document 
a. The upload percent % complete will be viewable in the bottom left corner of the 
browser. If it is stuck, close the browser and try uploading again. 
b. It is also possible to first transfer the photos onto the laptop (using the cable) and 
then navigating to the file in the laptop. 

 
66 
 
 
 
 
Method 2 – REDCAP Mobile App 
There are two ways to use the REDCAP mobile app to upload images. The first is to take a photo 
directly in the app (this saves the photo into the app). The second is to first take a photo to save the 
photo into the phone, and then uploading the photo into the app. The second is preferred because 
you have a copy of the photo in the camera in case there is an issue with the mobile app. 
#1 – Take photo in the app 
1. Open the patient’s REDCAP form 
2. Press “Upload Document” 
3. Press “Take Photo” 
4. Confirm that the photo is adequate for upload 
#2 – Take photo then upload into the app 
1. Open the phone’s camera 
2. Take photo 
3. Open the patient’s REDCAP form 
4. Press “Upload Document” 
5. Press “Load photo from camera” 
6. Select the file in the camera’s memory that you have already taken 
Explanation of REDCAP Mobile App 
The REDCAP mobile app allows you to collect data on a phone or tablet and upload the files onto the 
REDCAP server. This is supported by both Apple and non-Apple products. This method is not a 
preferable method of data collection because the mobile app and REDCAP server are not live 
synced. This means that data on the phone is first collected and then it needs to be synced with the 
server. Conversely, any changes made on the server need to be downloaded onto the mobile app for 
it to appear. There is a risk of overriding or losing data during the syncing process, making this form 
of data collection very risk. Because of this risk, the steps for using the REDCAP mobile app will not 
be discussed in detail here. It may be explored as a data collection modality in the future if 
necessary.  
One thing to note is that if the REDCAP mobile app is used, new records cannot be created using the 
mobile app even though the option appears. An error will occur when you try to upload the data. To 
work around this, create a new record on the REDCAP server, sync it to the mobile app by 
downloading the record on the mobile app, collect the data on the mobile app, and then sync the 
data back onto the server. 
Data Management 
Periodic evaluation and management of the data will be done to ensure that high quality data is 
being collected. This responsibility will fall to the protocol director. The following procedures will be 
performed on a bi-monthly basis on Sundays: 
o Export all data as Excel CSV file with labels and store on encrypted laptop 
o Create a backup of the project on REDCAP with everything except users 
o Examine record status dashboard and notify team of any inconsistencies or remaining data 
to collect 
o Execute all data quality checks 

 
67 
 
 
 
 
o Examine complications and review for patients from last 2 weeks and make sure 
adjudication review has been performed 
o Close any data resolution queries 
o Manage any open data queries that have not been completed by the review by date 
References 
 
1. 
Chandran A, Hyder AA, Peek-Asa C. The global burden of unintentional injuries and an 
agenda for progress. Epidemiol Rev. Apr 2010;32(1):110-120. 
2. 
Patton GC, Coffey C, Sawyer SM, et al. Global patterns of mortality in young people: a 
systematic analysis of population health data. Lancet. Sep 12 2009;374(9693):881-892. 
3. 
Mock C, Cherian MN. The global burden of musculoskeletal injuries: challenges and 
solutions. Clin Orthop Relat Res. Oct 2008;466(10):2306-2316. 
4. 
Beveridge M, Howard A. The burden of orthopaedic disease in developing countries. J Bone 
Joint Surg Am. Aug 2004;86-A(8):1819-1822. 
5. 
WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New 
Millennium. The burden of musculoskeletal conditions at the start of the new millennium : 
report of a WHO scientific group. Geneva: World Health Organization; 2003. 
6. 
Dormans JP, Fisher RC, Pill SG. Orthopaedics in the developing world: present and future 
concerns. J Am Acad Orthop Surg. Sep-Oct 2001;9(5):289-296. 
7. 
Museru LM, McHaro CN. The dilemma of fracture treatment in developing countries. Int 
Orthop. 2002;26(6):324-327. 
8. 
Zirkle LG, Jr. Injuries in developing countries--how can we help? The role of orthopaedic 
surgeons. Clin Orthop Relat Res. Oct 2008;466(10):2443-2450. 
9. 
Shah RK, Moehring HD, Singh RP, Dhakal A. Surgical Implant Generation Network (SIGN) 
intramedullary nailing of open fractures of the tibia. Int Orthop. Jun 2004;28(3):163-166. 
10. 
Shearer D, Cunningham, B., Zirkle, L. Population Characteristics and Clinical Outcomes from 
the SIGN Online Surgical Database. Techniques in Orthopaedics. 2009;24(4):273-276. 
11. 
Ikpeme I, Ngim N, Udosen A, Onuba O, Enembe O, Bello S. External jig-aided intramedullary 
interlocking nailing of diaphyseal fractures: experience from a tropical developing centre. Int 
Orthop. Jan 2011;35(1):107-111. 
12. 
Ogunlusi JD, St Rose RS, Davids T. Interlocking nailing without imaging: the challenges of 
locating distal slots and how to overcome them in SIGN intramedullary nailing. Int Orthop. 
Aug 2010;34(6):891-895. 
13. 
Naeem-Ur-Razaq M, Qasim M, Khan MA, Sahibzada AS, Sultan S. Management outcome of 
closed femoral shaft fractures by open Surgical Implant Generation Network (SIGN) 
interlocking nails. J Ayub Med Coll Abbottabad. Jan-Mar 2009;21(1):21-24. 
14. 
Ikem IC, Ogunlusi JD, Ine HR. Achieving interlocking nails without using an image intensifier. 
Int Orthop. Aug 2007;31(4):487-490. 
15. 
Sekimpi P, Okike K, Zirkle L, Jawa A. Femoral fracture fixation in developing countries: an 
evaluation of the Surgical Implant Generation Network (SIGN) intramedullary nail. J Bone 
Joint Surg Am. Oct 5 2011;93(19):1811-1818. 
16. 
Kooistra BW, Dijkman BG, Busse JW, Sprague S, Schemitsch EH, Bhandari M. The 
radiographic union scale in tibial fractures: reliability and validity. J Orthop Trauma. Mar 
2010;24 Suppl 1:S81-86. 
 
 
 
 

 
68 
 
 
 
 
 
Appendix and Supporting Documents 
 
OTA 42 Subclassification 
 
Under the AO/OTA Fracture Classification system, tibia fractures are designed as either 41 
(proximal), 42 (diaphyseal), and 43 (distal). The proximal and distal regions of the tibia are defined 
by the rule of squares. 
All OTA Type 42 fractures (regardless of subclassification) are eligible for inclusion in the study. 
 
Antibiotics Supply 
The following antibiotics were purchased from Dawa Plus Limited (Dar es Salaam, TZ). The order was 
coordinated by Ibrahim through a contact at the supplier. The ceftriaxone is a powder which needs to 
be reconstituted by sterilized saline water. 
TRIXONE Ceftriaxone Sodium Injection USP 1.0g (1 vial) 
Manufactured for: Abacus Pharma (A) Limited, East Africa 
Registration No.: TZ15H0073 
Storage: Store below 30C in a dry place. Protect from light 
Cost per vial: 1300TSH 
 
Super Amp Sterilised Water for Injections BP 
Manufactured by: Claris Lifesciences Limited 
Chacharwadi-Vasana, Ahmedabad-382 213, India 
Mfg. Lic. No: G/28A/5372-A 
B. No.: C250647 
Storage: Store at a temperature not exceeding 30C 
 
Gentamicin Injection BP 80mg 
10x2ml ampoule 
Each 2ml contains: gentamicin sulfate BP equivalent to gentamicin base (80,000 IU)  
Manufactured by: Vital Healthcare Pvt. Ltd. 
Works: Plot No. H-10, MIDC, Satpur, Nashik-422 007 
Regd Off: 5/6, Shreyas, 2nd Hasnabad Lane, Santacruz (W), Mumbai-400 054. India 

 
69 
 
 
 
 
Cost per vial: we were given a sample box of 10 ampoules and used that. No additional ampoules 
were purchased. 
 
Metris Metronidazole Injection USP (0.5% w/v) 100ml for IV use only 
M.L: G/28DA/LVP/4-A 
Manufactured by: Claris Lifesciences Limited 
Chacharwadi-Vasana, Ahmedabad-283 213, India 
Cost per bottle: 600TSH 
 
The following were purchased from the MOI pharmacy. This was to replenish gentamicin from time to 
time. Not much gentamicin was used. In order to purchase antibiotics in this way, a prescription 
needs to be written. The maximum number of ampoules provided per prescription is 15.  
 
Gentamicin Sulfate Injection 80mg/2ml 
Reg. No.: TAN05, 468 J01K CHE 
IV/IM 10 Ampoules/Box 
Manufactured by: Sichuan Long March Pharmaceutical Co. Ltd.  
Cost per vial: approximately 5000TSH for a box of 10 (500 TSH each) 
 
X-Ray Quality Control 
Good 
 
These are examples of good quality x-rays. The majority of the tibia is seen along with clear 
identification of the fracture site. 
 
   
 
 
 
Poor 

 
70 
 
 
 
 
 
An example of an inadequate x-ray is provided here. For the image on the left, notice that the 
fracture site as well as the distal portion of the tibia is missing. For the image in the midde, notice 
how the majority of the proximal tibia is missing. The image on the right suffers from both movement 
during the x-ray exposure and movement from the camera taking a photo of the image; however, 
enough of the tibia is exposed in the picture for it to be used.  
 
      
    
 
 
 
How to Recharge the Airtel USB Modems 
1. Purchase Airtel Vouchers or take from the study closet 
2. Scratch the voucher 
3. Turn off internet on the study phone  
4. Dial *104*PIN# on the study phone to add money to the study phone 
5. Send money to the USB modem 
a. Dial *149*99# 
b. Reply 3 for “Yatosha Intaneti” 
c. Reply 2 for “Buy for a friend” 
d. Reply with the phone number of the USB modem you are charging 
e. Reply 3 for Monthly Bundle 
f. 
Reply 1 for 3Gb 
g. Reply 1 for enroll 
6. Press *102# to check balance 
Yatosha Intaneti is 3GB for 1 month = 15000TSH 
*Add as much money as you need to buy the Yatosha Intaneti bundle you want 

 
71 
 
 
 
 
How to Recharge the Study phone with Airtime 
1. Purchase Airtel vouchers or take from the study closet 
2. Scratch the voucher 
3. Turn off internet on the study phone  
4. Dial *104*PIN# on the study phone to add money to the study phone 
5. Purchase Yatosha airtime bundle 
a. Dial *149*99# 
b. Reply 1 for “Yatosha” (the name of the Airtel airtime bundle) 
c. Reply 3 for Monthly Bundle 
d. Reply 1 for 175 talk minutes 
e. Reply 1 for enroll 
6. Press *102# to check balance 
The cheapest Yatosha Airtel Airtime is 10000TSH for one month 
Study Numbers and Passwords 
 
Joshua’s Airtel USB Modem: 068-994-7943 
Ibrahim’s Airtel USB Modem: 068-325-4780 
Justin’s Airtel USB Modem: 068-994-6071 
Study Phone Number: 068-994-7699 (Password is 696969) 
REDCAP Mobile App: admin password is 696969. The username is moi (password 696969) 
All study laptops have the password set to: igot (all lowercase) 
 
Additional Information for the Blue HP Study Laptop (Ibrahim’s Laptop) 
 
McAfee Security 
Email: tanzania.trauma.course@gmail.com 
Password: Muhimbili1 
 
Microsoft Office 365 
Name: MOI Research Team 
Email: tanzania.trauma.course@gmail.com 
Password: Muhimbili 
*Free for 1 year 
 
DropBox Account: 
First Name: MOI 
Last Name: Research Team 
Email: tanzania.trauma.course@gmail.com 
Password: Muhimbili 
 
Gmail Account 
Email: tanzania.trauma.course@gmail.com 
Password: Muhimbili 
 
EQ-5D Swahili Version 

Sample
2
UK (English) © 1990 EuroQol Group EQ-5D™ is a trade mark of the EuroQol Group
By placing a tick in one box in each group below, please indicate which statements best 
describe your own health state today.
Mobility
I have no problems in walking about

I have some problems in walking about

I am confined to bed

Self-Care
I have no problems with self-care

I have some problems washing or dressing myself

I am unable to wash or dress myself

Usual Activities (e.g. work, study, housework, family or leisure activities)
I have no problems with performing my usual activities

I have some problems with performing my usual activities

I am unable to perform my usual activities

Pain / Discomfort
I have no pain or discomfort

I have moderate pain or discomfort

I have extreme pain or discomfort

Anxiety / Depression
I am not anxious or depressed

I am moderately anxious or depressed

I am extremely anxious or depressed

EQ-5D English Version

Sample
3
UK (English) © 1990 EuroQol Group EQ-5D™ is a trade mark of the EuroQol Group
9
0
8
0
7
0
6
0
5
0
4
0
3
0
2
0
1
0
100
0
To help people say how good or bad a health state is, 
we have drawn a scale (rather like a thermometer) on 
which the best state you can imagine is marked 100 and 
the worst state you can imagine is marked 0.
We would like you to indicate on this scale how good or 
bad your own health is today, in your opinion. Please do 
this by drawing a line from the box below to whichever 
point on the scale indicates how good or bad your health 
state is today.
Best imaginable 
health state
Worst imaginable 
health state
Your own health 
state today

 
75 
 
 
 
 
 
UCSF-MOI Open Tibia Fracture Study – OTA Wound Classification 
 
 
As part of the study, we are collecting data on the types of wounds that our study 
participants have.  Please fill out this handout after the operation. Leave it in the patient’s 
file after you have filled it out. If you have any questions, please contact the study phone at 
06899-47699. 
 
 
Patient Name: ____________________________   
MRN: ____________________ 
 
 
Wound measurement (take the maximum length):___________ cm 
 
 
Skin 
 
 
 
❑ Laceration with edges that approximate 
 
 
 
 
 
❑ Laceration with edges that DO NOT approximate 
 
 
 
 
 
❑ Laceration associated with extensive degloving 
 
Muscle 
❑ No muscle necrosis OR some injury with function intact 
 
❑ Loss of muscle but remains functional OR localized necrosis 
in injured area that requires excision 
 
❑ Dead muscle, loss of function, partial or complete 
compartment excision, complete disruption disruption of 
muscle-tendon unit, muscle injury not approximatable 
 
Arterial 
 
 
❑ No injury 
 
 
 
 
 
❑ Injury, no ischemia 
 
 
 
 
 
❑ Injury with distal ischemia 
 
Contamination 
 
❑ None or minimal contamination 
 
 
 
 
 
❑ Surface contamination (not ground in) 
 
❑ Contaminant embedded in bone or deep soft tissue OR high 
risk environmental conditions (barnyard, fecal, dirt water, etc.) 
 
Bone Loss 
 
 
❑ None 
 
❑ Bone loss, but still some contact between proximal and distal 
fragments 
 
 
 
 
 
❑ Segmental bone loss 
 
 
 
 
 
Patient Observation Chart 

 
76 
 
 
 
 
 
To be used post-op after patient is discharged to the ward: 
 
Open Tibia Study Patient Observation Chart 
 
Name: ___________________ MRN: ______________Ward #: ______ 
 
Antibiotic  
Dose # 
Date 
Time 
Time Given 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date to Check 
Evaluation 
Fixed 
 
Pre-Op  
___________ 
□ Good 
□ Missing 
□ Redo 
□ 
Post-Op  
___________ 
□ Good 
□ Missing 
□ Redo 
□ 
 
□ Date of Birth (with day and month) recorded 
□ Contact information complete 
□ Follow-up schedule created 
 
Standard Study Antibiotics Regiment 
- None or Mild Contamination: Ceftriaxone (1g every 24hr for 2 days) 
- Surface Contamination (not ground in): Ceftriaxone (as above) + Gentamycin (80mg every 12hr for 
2 days) 
- Severe or High-Risk: Ceftriaxone + Gentamycin (as above) + Metronidazole (500mg every 8hr for 2 
days) 
 
 
MOI Wifi Codes 
 
The following wifi codes are for the MOI wifi. They differ depending on where you are in the hospital 
2151298000 
moi2151298 
2151298moi 

 
 
 
Page 1 of 3 
MUHIMBILI ORTHOPAEDIC INSTITUTE IN COLLABORATION WITH THE 
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 
 
CONSENT TO BE IN RESEARCH 
 
Study Title: Initial External Fixation or Intramedullary Nailing for Gustilo 3A Tibial Shaft 
Fractures: a Randomized Controlled Trial in Dar es Salaam, Tanzania 
 
This is a research study, and you do not have to take part.  The researchers from Muhimbili 
Orthopaedic Institute (MOI) will explain this study to you.  The co-principal investigators are Dr. 
Billy Haonga and Dr. Saam Morshed.  The investigators are from MOI and the University of 
California, San Francisco (UCSF). If you have any questions, you may ask the researcher. 
 
You are being asked to take part in this study because you have a tibial fracture.   
 
In this study, the researchers are collecting data to determine the outcome of various treatments 
for tibial fractures.   The research is paid for by grant funding from the Doris Duke Charitable 
Foundation (DDCF), the Wyss Foundation, and UCSF Institute for Global Orthopaedics and 
Traumatology.  
 
What will happen if I take part in this study? 
 
If you agree to be in this study, you will be randomly assigned one of two well-established 
treatments for the treatment of open (Type3A) tibia fractures.  The first treatment option is 
fixation of the fracture with a nail that goes inside the broken bone and the other is stabilization 
of the fracture with an external fixator.  The nail is not typically removed, however, the external 
only stays on long enough for the bone to show signs of healing and is typically removed 
between 8 and 12 weeks after application.   The initial treatment option involves thorough 
cleaning of all exposed tissues resulting from the open fracture and the need for further care of 
the wound (dressing changes or further surgery for wound care) will depend on the treating 
surgeon’s interval assessments of the wound. 
 
You will also be asked to share information about your current state of health and details of your 
injury.  In addition, we will ask you to complete a short 5 question survey. The X-ray images that 
you took as part of your treatment plan will be made available to the research team. 
 
You will also be asked to come back for routine follow-up visits at 6 weeks, 3 months, 6 months, 
and 1 year after the injury. At each of these visits, you will answer questions and complete the 
survey. You will also be asked to take plain film X-ray images of the fracture site. 
 
We anticipate it will take about 30 minutes at the time of enrollment and at each follow up 
appointment to gather the information for the study. Your information will be recorded and 
shared with other researchers at MOI and UCSF. 
 
 
 

 
 
 
Page 2 of 3 
Are there any risks to me or my privacy? 
Your choice to participate in the study will not affect your treatment in any way.  However, some 
of the questions may make you feel uncomfortable or raise unpleasant memories.  You are free 
to skip any question at any point during the study.  
We will do our best to protect the information we collect from you.  Information which identifies 
you will be kept secure.  Only a small number of researchers will have direct access to your 
identifying information.  If this study is published or presented at scientific meetings, names and 
other information that might identify you will not be used. 
Are there benefits? 
There is no benefit to you in terms of the care you receive for your injury.  The cost of all follow-
up visits and x-rays obtained during the appointments required for the study will be paid for, and 
you will be allowed to bypass waiting lines at the clinic.   
Can I say “No”? 
Yes, you do not have to participate in the study.  If you choose not to be in this study, there will 
be no consequences to the type of treatment or quality of care you receive for your injury.  
Are there any payments or costs? 
There will be no payments made directly to patients.  However, the costs of the follow up 
medical care including clinic visits and X-rays will be provided for free at no cost to you.  
Who can answer my questions about the study? 
You can talk with the study coordinator about any questions, concerns, or complaints you have 
about this study.  You may also contact the co-principal investigators directly: 
Billy Haonga, MD, Muhimbili Orthopaedic Institute (bhaonga@gmail.com) 
Edmund Eliezar, MD, Muhimbili Orthopaedic Institute (ndalama@yahoo.com)  
 
If you wish to ask questions about the study or your rights as a research participant to someone 
other than the researchers or if you wish to voice any problems or concerns you may have about 
the study, please call the National Institute for Medical Research at +255-22-2121400 or the 
UCSF Office of the Committee on Human Research at 1-415-476-1814.  
 
   

 
 
 
Page 3 of 3 
CONSENT 
 
PARTICIPATION IN RESEARCH IS VOLUNTARY. 
 
You have been given copies of this consent form to keep. 
 
If you wish to be in this study, please sign below. 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 
Participant's Signature for Consent 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 
Person Obtaining Consent 
 

 
79 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tarehe. 
 
 
   Sahihi ya mshiriki kutoa idhini. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Tarehe. 
 
 
Sahihi ya mpokeaji wa Idhini. 
 
 
 
UCSF-MOI Open Tibia Fracture Study - Department 
Information Sheet 
 
 
Please contact the study phone number highlighted below to reach whoever is on call. 
 
068-994-7699 
 
PATIENT ARRIVAL TIMES AND WHAT TO DO 
 
Time of 
Day 
What to Do 
Screening 
Antibiotics 
7am to 
5pm 
Call study phone 
for all open tibias 
Researcher will find you and 
assist you with screening 
Researcher will provide for 
you to administer 
5pm to 
11pm 
Call study phone 
for all open tibias 
Researcher will assist with 
screening over phone and 
come to hospital if participant 
is a candidate 
Antibiotics have been 
provided to emergency nurse 
on duty for you to administer 
11pm to 
7am 
Push patients to 
morning and call 
study phone at 
7am 
Researcher will assist in the 
morning 
Antibiotics have been 
provided to emergency nurse 
on duty for you to administer 
 
STANDARD ANTIBIOTICS REGIMENT 
 
Antibiotics should be administered AS CLOSE TO ARRIVAL AT MOI AS POSSIBLE. 
 
Condition 
Treatment 
None or mild contamination 
Ceftriaxone 1g every 24 hr for 2 days 
Surface contamination (not ground in) 
Ceftriaxone 1g every 24 hr for 2 days  
PLUS Gentamycin 80mg every 12 hr for 2 days 
Contaminant embedded in bone or deep soft 
tissue OR high risk environmental conditions 
(barnyard, fecal, dirt water, etc.) 
Ceftriaxone 1g every 24 hr for 2 days 
PLUS Gentamycin 80mg every 12 hr for 2 days 

 
80 
 
 
 
 
PLUS Metronidazole 500mg every 8hr for 2 days 
 
RANDOMIZATION AND OTA WOUND CLASSIFICATION  
 
Our researchers will randomize your patient to either nail or exfix after you have finished debriding 
the wound and ask you to classify the wound. 
 
Other Contact Information: 
 
Max Liu (Research Fellow): 
 
 
0688633947 (maxliu@stanford.edu) 
Joshua Ngayoma (Research Coordinator): 
0714738989 (skandoj@yahoo.co.uk) 
Ibrahim Sasillo (Research Coordinator): 
 
0713480302 (namensah47@gmail.com) 
Justin Kessy (Research Coordinator):  
0718038645 (kessygasto53@yahoo.com) 
Billy Haonga (MD): 
 
 
 
0754563761  (bhaonga@gmail.com) 
Edmund Eliezer (MD):  
 
 
0753100500  (ndalama@yahoo.com)