ORthopaedic Trauma Anemia With Conservative Versus Liberal Transfusion
Phase: PHASE4
Conditions: Anemia
Sponsor: Indiana University

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ORthopaedic trauma Anemia with Conservative versus Liberal transfusion 
(ORACL) 
(NCT02972593) 
 
  
Brian Mullis, MD 
Chief, Orthopaedic Trauma Service 
Eskenazi Health, Fifth Third Bank Building 
720 Eskenazi Avenue 
2nd  Floor, Suite 2-S 
Indianapolis, IN 46202 
Associate Professor 
Indiana University School of Medicine 
Assistant: 317-880-3600 
Office: 317-880-3591 
Fax: 317-880-0138 
 
 
Participating Sites: 
 
Eskenazi Hospital-Orthopaedics (Site PI: Karl Shively, MD) 
Methodist Hospital-Orthopaedics (Site PI: Walter Virkus, MD) 
WellStar Atlanta Medical Center (Site PI: Jennifer Bruggers, MD) 
Atrium Health Musculoskeletal Institute-Charlotte, NC (Site PI: Laurence 
Kempton, MD) 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 
Follow-up and Record Retention 
11.0 
Investigator Environment and Support 
12.0 
References 
 
Appendix A: Screening Form CRF 
Appendix B: Contact Information CRF 
Appendix C: Pre-injury MFA CRF 
Appendix D: Follow-up MFA CRF 
Appendix E: 2 minute walk test CRF 
Appendix F: Adverse Event CRF 
Appendix G: Protocol Deviation CRF 
Appendix H: Escape Criteria CRF 
Appendix I: Length of Hospital Stay CRF 
Appendix J: AAOS Abstract February 2011 
Appendix K: American Journal of Orthopaedics Article, 2015 

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1.0 
Background 
 
Over 13 million units of blood are transfused each year.  While transfusion can 
certainly be life saving, numerous studies over the last twenty years have shown 
significant, dose-dependent increases in morbidity, mortality, and cost with each unit of 
packed red blood cells transfused.{Leal-Noval, 2001 #1}  Transfusion is one of the most 
common interventions made in the critically ill population, however the negative effects 
of transfusion-related infection is well documented in recent literature.{Leal-Noval, 2001 
#1;Leal-Noval, 2001 #1;Hebert, 1999 #2;Carson, 1999 #3;Edna, 1992 #6;Hill, 2003 
#8;Vincent, 2002 #9;Taylor, 2002 #10}  There is no question that transfusion of blood 
products can be life-saving to an acutely ill trauma patient, but there is little evidence to 
help the Orthopaedic Surgeon decide when a transfusion is indicated in an asymptomatic 
anemic patient who is no longer in need of acute resuscitation. 
 
Several studies have analyzed healthy individuals with an isovolemic reduction in 
hemoglobin to a level of 5.0 (g/dL).{Leung, 2000 #16;Weiskopf, 1998 #17}  They found 
no significant compromise in oxygen delivery to the tissues.  Currently there is a lack of 
clinical data to suggest adequate red blood cell (RBC) transfusion endpoints in trauma 
surgery.{Johnston, 2006 #18}  Given the lack of evidence to support transfusion triggers 
for young, healthy, asymptomatic Orthopaedic trauma patients, the purpose of this study 
will be to investigate the risk of complications associated with permissive anemia in this 
population.   
 
Orthopaedic trauma patients treated at Eskenazi (previously Wishard) Hospital, a 
level 1 trauma center, are routinely allowed to be permissively anemic, or allowed to run 
as low as a Hemoglobin of 5 g/dL if they are young and healthy (see inclusion/exclusion 
criteria for objective definition) and asymptomatic from anemia.  A retrospective review 
was performed using the inclusion/exclusion criteria proposed in this study to evaluate if 
a prospective study would be ethical and to provide a power analysis for number of 
patients needed to reject the null hypothesis.  Over a 3 year period (2006-2009), 104 
patients were identified who met the inclusion/exclusion criteria proposed in this study 
and were available for 1 year follow-up.  This study controlled for Injury Severity Score, 
patient age, gender, and whether the patient had received multiple surgeries.  We found 
that patients who were allowed to be permissively anemic (allowed to drop to a Hgb of 5 
g/dL if asymptomatic at rest) had a lower complication rate (p<0.01) than those who were 
transfused to maintain a higher hemoglobin.  Additionally, there appeared to be a dose-
dependent affect (p=0.02) with higher complications seen in patients receiving multiple 
units of allogeneic blood.  This data was presented at both the American Academy of 
Orthopaedic Surgery (2011) and Orthopaedic Trauma Association (2011) annual 
meetings and the manuscript is currently being reviewed for publication.  This 
retrospective study does not prove causation of higher complication rates associated 
directly with transfusion, but does suggest there may be a lower complication rate in 
patients allowed to be permissively anemic.  The largest barrier to publication of this 
retrospective study has been the repeated comments by reviewers that a prospective study 
is needed. 
 
Dr. Mullis, Chief of Orthopaedic Trauma at Eskenazi Hospital, has met with the 
Chief of Anesthesia at Eskenazi Hospital, John Hasewinkel, and the Chief of Trauma for 
General Surgery, Gerry Gomez, to develop the inclusion and exclusion criteria listed 

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below so that this study might be completed in a multi-disciplinary approach with all 
providers agreeing to the inclusion and exclusion criteria and escape criteria listed below. 
 
2.0 
Rationale and Specific Aims 
 
 
Transfusion of Orthopaedic trauma patients is routinely done in asymptomatic 
individuals as there is no accepted national standard or recommendations from the 
American Academy of Orthopaedic Surgeons or the Orthopaedic Trauma Association for 
what level of anemia is appropriate in an asymptomatic patient.  Individual practitioners 
typically make this decision based on anecdotal experiences and expert opinion.  No 
prospective study has been performed to date to answer this question in this patient 
population. 
 
The null hypothesis of this proposed pilot study is that no difference will be seen 
with a liberal transfusion strategy to keep a patient’s hemoglobin above 7 g/dL versus a 
conservative strategy to keep the patient’s hemoglobin above 5.5 g/dL in patients 
asymptomatic at rest.  The primary outcome of this pilot study will be infection; defined 
as postoperative wound infection (superficial or deep) or other perioperative infection but 
not surgical site (urinary tract infection or pneumonia).  Deep infection is defined as the 
need for intravenous antibiotics or a return to surgery for debridement.  Superficial 
infection is defined as the use of oral antibiotics only successfully treat a surgical site  
infection.  Secondary outcomes will include pulmonary embolism, deep venous 
thrombosis, acute renal failure or insufficiency, nonunion, delayed union, compartment 
syndrome, osteomyelitis, nerve palsy, anoxic brain injury, cardiac ischemia or infarct, 
pancreatitis, or death, and the musculoskeletal functional assessment.  These same 
outcomes were evaluated in the retrospective study done at this institution which found 
no difference within any one complication, but when all complications were pooled there 
was a higher complication associated with the liberal transfusion strategy. 
 
3.0 
Inclusion/Exclusion Criteria 
 
Inclusion criteria:  
• Trauma patients admitted to participating hospital  with any Orthopaedic injury 
who have been determined to be stable by the Trauma Service (General Surgery) 
and are no longer within the resuscitation phase of initial treatment.  This is 
defined as a normal urine output (greater than 0.5 ml/kg/hr) and a systolic blood 
pressure greater than 90 mmHg for greater than 6 hours without fluid bolus or 
transfusion during that time 
• Age 18-50 
• Hemoglobin less than 9 g/dL or expected drop below 9 g/dL with planned surgery 
 
Exclusion criteria: 
• Pregnant ( urine pregnancy test will be done as standard of care) 
• Prisoner 
• Head injury (Glasgow Coma Scale less than 8 over 48 hours from presentation) 
• Known cardiac (coronary artery disease, atrial fibrillation, stent placement, 
congestive heart failure), renal (acute or chronic renal insufficiency or failure, 

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defined as having Serum Creatinine >1.2 at time of enrollment), liver (Childs C cirrhosis) or 
pulmonary disease (chronic obstructive pulmonary disease, abnormal pulmonary 
function tests or history of poor pulmonary function from any cause including 
acute traumatic conditions such as ARDS) 
• Unlikely to follow up in the surgeon’s estimation 
• Sickle Cell Anemia 
• History of cancer 
• Preexisting weakness, paresthesias, deformities, or other conditions which might 
affect functional outcome in the surgeon’s opinion 
• Spinal cord injury 
• Patients with burns expected to require operative treatment 
• COVID positive 
 
 
4.0 
Enrollment/Randomization 
 
 
A consensus opinion was reached in a multidisciplinary manner with multiple 
members of the Trauma team (General Surgery), Anesthesia, Physical Medicine and 
Rehab, and the Orthopaedic Trauma Service.  This team consisted of members from 
General Surgery (Timothy Hayward, Erik Streib, Clark Simons, Gerry Gomez), 
Anesthesia (John Hasewinkel, Jim Mitchell, Leilani Mullis), and Physical Medicine and 
Rehab (Angela Carbone) along with all members of the Orthopaedic Trauma Service 
(Jeff Anglen, Janos Ertl, Karl Shively) and the PI (Brian Mullis).  The opinions in escape 
criteria and definitions will be referred to below as “consensus opinion”.  A 
biostatistician was consulted after he had reviewed the data from the retrospective study 
previously performed at this institution to help design an appropriately powered 
prospective randomized pilot study. 
 
 
All Orthopaedic Trauma patients admitted to participating hospital will be 
screened for inclusion and exclusion criteria after they have been resuscitated and 
stabilized.  The consensus opinion of the “stable” patient was defined as an awake and 
alert patient with normal urine output and systolic blood pressure greater than 90 mmHG 
for greater than 6 hours without fluid bolus or resuscitation.  If a patient meets criteria for 
the study as noted above and is stable as defined above, the patient would be approached 
by either the Principal Investigator (PI) or a co-PI to determine interest and informed 
consent would be obtained for participation in the study. Patients who either refuse or are 
unable to consent will be tracked using the screening form. Enrollment would be 
performed in patients with a Hgb of 9 g/dL or less or in patients expected to drop below 9 
g/dL with planned procedures or continued (controlled) bleeding.  Randomization would 
not occur until the patient’s Hgb dropped below 7 g/dL at which time a sealed envelope 
would be opened to determine if the patient would be randomized to a liberal transfusion 
strategy (transfuse to keep Hgb >7 g/dL) or a conservative strategy (transfuse to keep 
Hgb > 5.5 g/dL).  If the patient’s Hgb does not drop below 7.0 g/dL, randomization will 
not be done. Prior to starting enrollment, envelopes will be made by blinded personnel 
using a randomization list generated to assign subjects to receive treatment either after 
hemoglobin drops below 5.5 or after hemoglobin drops below 7.0. Randomization was 

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done with a block size of 4 to ensure the treatment allocation was balanced throughout 
the study recruitment period. Escape criteria have been established by the consensus 
group to allow transfusion in patients with clinical concerns for symptomatic or 
dangerous levels of anemia despite randomization arm (please see Escape Criteria 
outlined in section 5.0) 
 
5.0 
Study Procedures 
 
If the patient remains asymptomatic at rest (defined as no chest pain, shortness of breath, 
or dizziness), transfusion would be determined by randomization to the liberal transfusion 
strategy to maintain Hgb at 7 g/dL or the conservative transfusion strategy of 5.5 g/dL.  
After each unit of blood is transfused a Hgb level would be checked to ensure appropriate 
Hgb levels are maintained as well as routine clinical practice (typically daily Hgb levels 
drawn until at least 2 consecutive days show no further drop with no further procedures 
or bleeding expected).  If the patient’s Hgb does not drop below 7.0 g/dL, randomization 
will not be done but patient will still be followed and patient outcomes will be collected 
as part of a non-treatment group. 
 
As noted in Section 4.0, a consensus group consisting of multiple physicians and the 
service chiefs from the Trauma Service (General Surgery), Orthopaedic Trauma Service, 
Anesthesia, and Physical Medicine and Rehab agreed to the following escape criteria to 
transfuse regardless of Hgb level or arm of randomization: 
 
Escape Criteria 
1. Patient has any of the following symptoms at rest: chest pain, shortness of breath, 
dizziness 
2. Patient has a mean arterial pressure less than 50 mmHg that is not responsive to 
fluid resuscitation 
3. At any time the patient’s heart rate increases by more than 30% above baseline 
while under anesthesia 
4. The patient’s urine output drops to less than 0.5 mL/kg/hour and remains 
decreased despite adequate rehydration with fluids 
5. Any objective evidence of cardiac ischemia including the following: EKG 
changes such as ST depression, an elevation of serum cardiac markers, a base 
deficit greater than 6, lactate greater than 2.5 that does not respond to fluid 
resuscitation 
6. A decrease in systolic blood pressure by 10% or more with exercise (physical 
therapy) that does not improve with fluid resuscitation 
7. Uncontrolled source of hemorrhage 
 
In addition to being followed daily while inpatient, patients would be followed at routine 
intervals following injury: 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 1 year.  
Radiographic and clinical data will be collected specific to the patient’s musculoskeletal 
injury and based on standard of care.  The primary outcome is infection defined as 
superficial infection (cellulitis treated with oral antibiotics) or deep infection (requires IV 
antibiotics or surgical debridement), osteomyelitis, pneumonia, urinary tract infection. 

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Secondary outcomes include renal insufficiency, cardiac ischemia or myocardial 
infarction, deep venous thrombosis, or any other medical complication encountered in the 
patient’s hospital or post-discharge course felt to be possibly related to the patient’s 
injury, procedure, or as a result of transfusion.  Secondary outcomes will also include 
standardized patient outcome scores; specifically, the Musculoskeletal Functional 
Assessment (MFA) done at baseline, 6 months, and 1 year, and the two minute walk test 
which would be conducted daily by a certified physical therapist while the patient is an 
inpatient and after they have been cleared for ambulation. Length of hospital stay will be 
recorded. Return to surgery or repeat hospitalization due to a complication will be other 
secondary outcomes. Completion of the Musculoskeletal Functional Assessment at 6 
months and 1 year may be done via phone or mail, if the subject is unable or unwilling to 
return for clinic follow up.  
 
 
 
 
 
Other possible risks, no matter which group subjects are randomized to, are: 
 
• 
Infection  
• 
Osteomyelitis  
• 
Pneumonia  
• 
Urinary tract infection 
• 
Renal insufficiency  
• 
Acute renal failure  
• 
Cardiac ischemia or infarct  
• 
Myocardial infarction  
• 
Pancreatitis  
• 
Deep venous thrombosis  
• 
Pulmonary embolism  
• 
Anoxic brain injury  
• 
Death 
• 
Delayed union  
• 
Non-union  
• 
Compartment syndrome   
• 
Nerve palsy  
 
Risk level is the same for all events listed. These risks are possible but there is a low chance for 
occurrence.  
 
 
 

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6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
 
 
Any adverse event identified by a member of the care or research team from any 
participating site will be documented in writing and the lead site principal investigator 
will be notified of adverse events as they occur.  All serious adverse events, protocol 
deviations, and noncompliance will be reported to the IRB in accordance with IU IRB 
policies and procedures. Significant adverse events that meet the policy criteria will be 
reported to the IRB as they occur.  All other adverse events will be documented and 
reported to the IRB at time of continuing review. 
 
A Data Safety Monitoring Plan (DSMP) will be in place to compare provisional 
outcomes prior to final enrollment. Per the DSMP, an orthopaedic surgeon not involved 
with the study will serve as the reviewer, looking at study data for obvious trends in 
higher complications in one study group. Monitoring of data that has been collected from 
all participating sites will be done every 6 months and findings will be submitted to the 
IRB at the time of continuing review. The data safety monitoring board will be comprised 
of: Todd McKinley-Independent Orthopaedic Surgeon, practices at Methodist (Board 
Chair), Dana Brock-Anesthesiologist at Eskenazi, Clark Simons-General Surgeon at 
Eskenazi, and Colin Terry- Biostatistician at Methodist. Qing Yu, PhD- Assistant 
Research Professor of Orthopaedic Surgery at IU will provide statistical analysis as 
needed. The DSMB has the independent ability to stop the study at any time if there is a 
concern for patient safety. 
 
 
 
7.0 
Study Withdrawal/Discontinuation 
 
 
Subjects have the right to withdraw from the study at any time and for any reason without 
prejudice to future medical care. If a subject wishes to withdraw from the study, they 
must notify a member of the research team. Once withdrawn, no further data will be 
collected from the subject.   
 
 
8.0 
Statistical Considerations 
 
 
Sample size: 
This is a pilot study since the primary purpose of this study is to collect preliminary data on 
estimating the complication rates for orthopedic trauma patients who will receive blood 
transfusion either with a liberal transfusion strategy or a conservative strategy. The primary 
outcome of this study is whether a patient develops a complication while following a 

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conservative or liberal transfusion strategy for anemia. From our retrospective study, we 
anticipate the true complication rate would be anywhere between 30% and 50%. We want to 
estimate this proportion with 95% confidence and no more than 14% margin of error. With a 
sample size of 50 per group we would able to reach this goal. For example, if the true proportion 
is 40%, the margin of error will be 13.6% and the maximum margin of error would be 13.9% 
when the true proportion is 50%.  
Up to 370 subjects will be enrolled as part of the non-treatment group. 
   
Data Analysis: 
The primary endpoint is a dichotomous outcome, the presence or absence of a 
complication at post blood transfusion. A point estimate (sample proportion) and a 95% 
confidence interval for the proportion will be reported. This proportion will be computed 
for each of the two blood transfusion strategies. Although we did not power the study to 
detect a difference in complication rate between two strategies, we will compare the 
complication rates between two groups of patients. Descriptive statistics, like, mean, 
median, standard deviation for continuous outcomes will be used to describe the subjects’ 
characteristics at baseline. Frequency counts and percent will be used for the categorical 
outcomes. Baseline clinical and demographic data will be compared between two groups 
to assess the effectiveness of the randomization. Dichotomous and ordinal variables will 
be examined using chi-square tests and continuous measures with Student’s t-tests.  
Exploratory analysis will be performed to compute p-values which will be presented as 
an aid to evaluate the overall comparability of the treatment groups at baseline. Logistic 
regression model will be used to compare the complication rate or infection rate between 
two groups and baseline covariates will be included in the model if two groups are found 
to be significantly different in those covariates.  
 
 
 
9.0 
Privacy/Confidentiality Issues 
 
 
Standard HIPAA practices will apply to all sensitive data recorded for study purposes.  
All attempts will be made to maintain confidentiality between study participants and the 
research team. Computer/files will be password protected, kept behind locked doors, and 
located in an area with no public access. 
 
 
10.0 
Follow-up and Record Retention 
 
 
Duration of the study will last approximately 3 years or until 100 patients have been 
enrolled with one year follow-up and all necessary data has been collected and analyzed.   
 

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Upon study completion, records will be retained for a minimum of 7 years as required by 
state law.  After mandatory retention period, sensitive information will be disposed of by 
means of hospital provided secure document disposal. 
 
 
11.0 
Investigator Environment and Support 
 
 
The Orthopaedic research team based at Eskenazi Health has a long history of successful 
participation in prospective trauma research studies.  The PI has successfully partnered 
with Eskenazi Health to waive fees for research patients to return for appointments in 
clinic.  As it would be unethical to charge patients for research appointments, both 
facility and physician charges are waived.  This helps patients defray costs for parking 
and travel, and significantly decreases the loss to follow-up.   
 
This study represents a landmark multidisciplinary approach to prospective research at 
Eskenazi Health.  The PI spent over a year recruiting and meeting with 30 IU clinical 
scientists from the disciplines of Orthopaedic Trauma, General Surgery, Anesthesiology, 
Physical Medicine & Rehab, and two IU PhD biostatistician.  This protocol represents the 
consensus opinion of all of these faculty.  The team consists of clinicians who prefer a 
conservative transfusion strategy, as well as those who prefer a more liberal transfusion 
strategy. The protocol was revised multiple times until all clinical scientists felt it was a 
safe and responsible approach to further study transfusion strategies in this young, 
healthy patient population.   
 
The research team also consists of two full-time research coordinators, Valda Frizzell and 
Molly Moore, who have a cumulative experience of decades in participating in 
prospective studies such as this. 
 
 
12.0 References: 
 
 
1. 
Leal-Noval, S.R., et al., Transfusion of blood components and postoperative 
infection in patients undergoing cardiac surgery. Chest, 2001. 119(5): p. 1461-8. 
2. 
Hebert, P.C., et al., A multicenter, randomized, controlled clinical trial of 
transfusion requirements in critical care. Transfusion Requirements in Critical 
Care Investigators, Canadian Critical Care Trials Group. N Engl J Med, 1999. 
340(6): p. 409-17. 
3. 
Carson, J.L., et al., Risk of bacterial infection associated with allogeneic blood 
transfusion among patients undergoing hip fracture repair. Transfusion, 1999. 
39(7): p. 694-700. 
4. 
Edna, T.H. and T. Bjerkeset, Association between blood transfusion and infection 
in injured patients. J Trauma, 1992. 33(5): p. 659-61. 

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5. 
Hill, G.E., et al., Allogeneic blood transfusion increases the risk of postoperative 
bacterial infection: a meta-analysis. J Trauma, 2003. 54(5): p. 908-14. 
6. 
Vincent, J.L., et al., Anemia and blood transfusion in critically ill patients. 
JAMA, 2002. 288(12): p. 1499-507. 
7. 
Taylor, R.W., et al., Impact of allogenic packed red blood cell transfusion on 
nosocomial infection rates in the critically ill patient. Crit Care Med, 2002. 
30(10): p. 2249-54. 
8. 
Leung, J.M., et al., Electrocardiographic ST-segment changes during acute, 
severe isovolemic hemodilution in humans. Anesthesiology, 2000. 93(4): p. 1004-
10. 
9. 
Weiskopf, R.B., et al., Human cardiovascular and metabolic response to acute, 
severe isovolemic anemia. JAMA, 1998. 279(3): p. 217-21. 
10. 
Johnston, P., et al., Is perioperative blood transfusion a risk factor for mortality 
or infection after hip fracture? J Orthop Trauma, 2006. 20(10): p. 675-9. 

Appendix A: Screening Form 
 
Subject ID:____________________ 
                                                                   Date:_____/_____/_____ 
 
  
 
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Inclusion: (Must answer YES to all) 
 
1. 
Patients aged 18 to 50 years 
 Yes  No 
2. 
Trauma patients admitted to participating hospital with any Orthopaedic injury who have been 
determined to be stable by the Trauma Service (General Surgery) and are no longer within the 
resuscitation phase of initial treatment.  This is defined as a normal urine output (greater than 0.5 
ml/kg/hr) and a systolic blood pressure greater than 90 mmHg for greater than 6 hours without 
fluid bolus or transfusion during that time 
 Yes  No 
3. 
Hemoglobin less than 9 g/dL or expected drop below 9 g/dL with planned surgery 
 Yes  No 
 
Exclusion: (Must answer NO to all) 
 
 
1. 
Women who are pregnant 
 Yes  No 
2. 
Prisoner 
 Yes  No 
3. 
Head injury(Glasgow Coma Scale less than 8 over 48 hours from presentation) 
 Yes  No 
4. 
Known cardiac, renal (defined as having Serum Creatinine >1.2 at time of enrollment), liver, or 
pulmonary disease 
 Yes  No 
5. 
Sickle cell anemia 
 Yes  No 
6. 
History of cancer 
 Yes  No 
7. 
Preexisting weakness, paresthesias, deformities, or other conditions which might affect functional 
outcome in the surgeon’s opinion 
 Yes  No 
8. 
Spinal cord injury 
 Yes  No 
9. 
Patients with burns expected to require operative treatment 
 Yes  No 
10. Unlikely to follow-up, as determined by the attending physician 
 Yes  No 
11. COVID positive 
 Yes  No 
 
If you answered yes to any of the exclusion items 1-11, the patient should be excluded. 
 
Patient Enrollment Status: 
□  Included 
□  Excluded 
□  Refusal to consent (otherwise met inclusion/exclusion criteria)  
□  Inability to consent (otherwise met inclusion/exclusion criteria)  
 
 

Appendix B: Patient Contact Form 
Subject ID:_________________                                                                                                     Date:____/____/____                
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Patient Name: _____________________________________ 
 
DOB: _____/_____/_____ 
Address: _________________________________________  
 
City: _________________ 
Zip Code: __________ 
Home Phone: (       )         -________  
Cell Phone: (       )         -________ 
 
Alternate Contact # 1 
Name: ___________________________________________ 
 
Relationship to patient: __________ 
Address: _________________________________________  
 
City: _________________ 
Zip Code: __________ 
Home Phone: (       )         -________  
Cell Phone: (       )         -________ 
 
Alternate Contact # 2 
Name: ___________________________________________ 
 
Relationship to patient: __________ 
Address: _________________________________________  
 
City: _________________ 
Zip Code: __________ 
Home Phone: (       )         -________  
Cell Phone: (       )         -________ 
 
 
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________ 

Appendix C: Pre-Injury Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                                Visit Interval:  Pre-injury 
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Musculoskeletal Function Assessment 
 
 
We would like you to answer the questions in this survey based on your condition before your 
injury.   
 
Please answer "YES" or "NO" to each question by putting a check in the box □ next to the 
question.  If the question was true for you before your injury, choose "YES".  If the question 
was not true for you before your injury, choose "NO". 
 
If you wish to comment on any of the questions, please use the space in the margins.  Please 
answer all questions, even though some of the questions may not seem to apply to you. 

Appendix C: Pre-Injury Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                                Visit Interval:  Pre-injury 
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ACTIVITIES USING YOUR ARMS OR LEGS 
 
This first set of questions is about using your arms or legs to do such things as reaching, walking, and 
carrying. Before your injury . . . 
1. Were you able to walk? 
□ Yes 
□ No 
2. Did you feel unsteady on your feet? 
□ Yes 
□ No 
3. Was it difficult for you to reach up high? 
□ Yes 
□ No 
4. Did you straighten or bend your arm(s) completely? 
□ Yes 
□ No 
5. Did you straighten or bend your leg(s) completely? 
□ Yes 
□ No 
6. Did you pivot? 
□ Yes 
□ No 
7. Did you climb up and down ladders? 
□  Yes 
□ No 
8. Did you have to rest often when walking? 
□  Yes 
□ No 
9. Did you avoid stairs? 
□  Yes 
□ No 
10. Did you stand for long periods of time? 
□  Yes 
□ No 
11. Was it hard for you to get moving after you’d been sitting or lying down? □  Yes 
□ No 
12. Did you always walk with a limp? 
□  Yes 
□ No 
13. Did your leg sometimes lock or give-way? 
□  Yes 
□ No 
14. Did you have trouble getting in or out of a low chair? 
□  Yes 
□ No 
15. Did you have trouble getting in or out of bed? 
□  Yes 
□ No 
16. Did you kneel? 
□  Yes 
□ No 
17. Did you pick up things from the floor? 
□  Yes 
□ No 
18. Did you run at all? 
□  Yes 
□ No 
19. Did you have trouble getting in or out of a car? 
□  Yes 
□ No 
20. Had you stopped using public transportation because of your physical 
condition? 
□  Yes 
□ No 
 
Before your injury, how much were you bothered by problems using your arms or legs?  
(Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 

Appendix C: Pre-Injury Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                                Visit Interval:  Pre-injury 
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ACTIVITIES USING YOUR HANDS 
 
The following questions are about activities using your hands. Before your injury . . . 
1. Did you have difficulty squeezing things? 
□ Yes 
□ No 
2. Could you make a tight fist? 
□ Yes 
□ No 
3. Was it hard for you to put your hand in your pocket? 
□ Yes 
□ No 
4. Did you have difficulty turning knobs or levers (for example, opening 
doors, rolling down car windows)? 
□ Yes 
□ No 
5. Did you have trouble holding a book? 
□ Yes 
□ No 
6. Did you have difficulty writing or typing? 
□ Yes 
□ No 
7. Did you have trouble opening medicine bottles or jars? 
□  Yes 
□ No 
 
Before your injury, how much were you bothered by problems using your hands? (Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
WORK AROUND YOUR HOME 
 
These questions are about activities around your home, including such things as cooking, cleaning, 
maintenance, or repairs. Before your injury . . . 
1. Did you need help with housework or yard work? 
□ Yes 
□ No 
2. Did you do as much housework or yard work as you wanted? 
□ Yes 
□ No 
3. Was it difficult for you to do household chores because they took so much 
effort? 
□ Yes 
□ No 
4. Did you mop or sweep or vacuum? 
□ Yes 
□ No 
5. Was scrubbing a pan or dish difficult? 
□ Yes 
□ No 
6. Did you need someone to cook for you? 
□ Yes 
□ No 
7. Did it take you a long time to do household chores? 
□  Yes 
□ No 
8. Was it difficult for you to shop for groceries or other thing? 
□  Yes 
□ No 
9. Had you stopped doing car, house, or maintenance repairs because of 
your physical condition? 
□  Yes 
□ No 
 
 
 

Appendix C: Pre-Injury Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                                Visit Interval:  Pre-injury 
Study #1402557771 
 
v. 07/31/2020 
 
     
 
Before your injury, how much were you bothered by problems doing work around your home? (Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
SELF CARE ACTIVITIES 
 
The following questions are about taking care of yourself. Before your injury . . . 
1. Did you wear things that were easier to get into? 
□ Yes 
□ No 
2. Did you sometimes need help from others to get dressed? 
□ Yes 
□ No 
3. Did you struggle with buttons, snaps, hooks, zippers? 
□ Yes 
□ No 
4. Did you have trouble pulling clothes on over your head? 
□ Yes 
□ No 
5. Was it difficult for you to put on shoes, socks, or stockings? 
□ Yes 
□ No 
6. Was it a chore for you to dress because it took so long? 
□ Yes 
□ No 
7. Was it difficult to brush your teeth? 
□  Yes 
□ No 
8. Did you have a difficult time cutting your fingernails? 
□  Yes 
□ No 
9. Did you need help keeping yourself clean after going to the bathroom? 
□  Yes 
□ No 
10. Was it difficult for you to get on or off the toilet? 
□  Yes 
□ No 
11. Was it hard for you to get in or out of the bathtub or shower? 
□  Yes 
□ No 
12. Did you sit while showering? 
□  Yes 
□ No 
13. Did you need help washing yourself? 
□  Yes 
□ No 
14. Did you need help eating? 
□  Yes 
□ No 
15. Was it hard for you to cut food? 
□  Yes 
□ No 
16. Were you stuck at home because of your physical condition? 
□  Yes 
□ No 
17. Had you stopped going out by yourself? 
□  Yes 
□ No 
18. Had you stopped driving because of your physical condition? 
□  Yes 
□ No 
 
Before your injury, how much were you bothered by problems caring for yourself? (Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 

Appendix C: Pre-Injury Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                                Visit Interval:  Pre-injury 
Study #1402557771 
 
v. 07/31/2020 
 
     
 
SLEEP AND REST 
 
These questions are about changes or problems you may have experienced with sleep and rest. Before 
your injury . . . 
1. Were you tired all of the time? 
□ Yes 
□ No 
2. Did you have trouble falling asleep at night? 
□ Yes 
□ No 
3. Did you have difficulty sleeping the whole night? 
□ Yes 
□ No 
4. Was it hard for you to get comfortable to sleep? 
□ Yes 
□ No 
5. Did you wake up sooner than you would like? 
□ Yes 
□ No 
6. Did you have disturbing dreams? 
□ Yes 
□ No 
 
Before you injury, how much were you bothered by problems with sleep and rest? (Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
LEISURE and RECREATIONAL ACTIVITIES 
 
The following questions are about changes or problems you may have had before your injury with 
leisure time or recreational activities. These activities may include such things as hobbies, sports, crafts, 
gardening, aerobics, or volunteering. Before your injury . . . 
1. Was your physical fitness worse because of your health or physical 
condition? 
□ Yes 
□ No 
2. Did you do less of your usual physical recreational activities because of 
your health or physical condition? 
□ Yes 
□ No 
3. Had you stopped doing all of your usual physical recreational activities? 
□ Yes 
□ No 
4. Were you doing fewer leisure activities (such as hobbies, crafts, gardening, 
card playing, going out with friends) because of your health or physical 
condition? 
□ Yes 
□ No 
 
Before your injury, how much were you bothered by problems doing leisure and recreational activities? (Please check 
one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
 

Appendix C: Pre-Injury Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                                Visit Interval:  Pre-injury 
Study #1402557771 
 
v. 07/31/2020 
 
     
RELATIONSHIPS: FAMILY and FRIENDS 
 
These questions are about your relationships with family, friends, and other important people in your 
life. Before your injury . . . 
1. Was there a strain in your relationships with either your friends or family? □ Yes 
□ No 
2. Did you feel you just didn’t want to be around anybody? 
□ Yes 
□ No 
3. Was it hard for you to get either your family or friends to help you do 
things? 
□ Yes 
□ No 
4. Were you lonely? 
□ Yes 
□ No 
5. Did you feel that either your friends or family had shied away from you? 
□ Yes 
□ No 
6. Did you often act irritable towards those around you (for example, snap at 
people, give sharp answers, criticize easily)? 
□ Yes 
□ No 
7. Did you miss being with either your friends or family? 
□ Yes 
□ No 
8. Did you feel like being less intimate because of your physical condition? 
□ Yes 
□ No 
9. Had your sexual life changed because of your physical condition? 
□ Yes 
□ No 
10. Did you enjoy sex less because of your physical condition? 
□ Yes 
□ No 
 
Before your injury, how much were you bothered by problems you had with your friends, family, and other important 
people in your life? (Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
THINKING 
 
These questions are about thinking, concentrating, or remembering. Before your injury . . . 
1. Did it take you a long time to figure things out? 
□ Yes 
□ No 
2. Did you have problems with concentration? 
□ Yes 
□ No 
3. Were you confused and scattered? 
□ Yes 
□ No 
4. Were you forgetful? 
□ Yes 
□ No 
 
Before your injury, how much were you bothered by problems with thinking, concentrating, and remembering?  (Please 
check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 

Appendix C: Pre-Injury Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                                Visit Interval:  Pre-injury 
Study #1402557771 
 
v. 07/31/2020 
 
     
 
LIFE CHANGES and FEELINGS 
 
The following questions are about the day to day adjustments and feelings you may have been 
experiencing in your life before your injury. Before your injury . . . 
1. Did you sometimes use your physical condition as an excuse not to do 
things? 
□ Yes 
□ No 
2. Did you have to concentrate when using your hands, arms, legs, or feet? 
□ Yes 
□ No 
3. Did you avoid using your hands, arms, legs, or feet? 
□ Yes 
□ No 
4. Did you protect your hands, arms, legs, or feet? 
□ Yes 
□ No 
5. Did you accept you physical condition? 
□ Yes 
□ No 
6. Did you feel your life had changed because of your health or physical 
condition? 
□ Yes 
□ No 
7. Did you feel your physical condition was getting worse over time? 
□ Yes 
□ No 
8. If you did too much in one day, did it affect what you did the next day? 
□ Yes 
□ No 
9. Did you feel disabled, even though you may have looked fine to others? 
□ Yes 
□ No 
10. Did you feel useless? 
□ Yes 
□ No 
11. Did you feel unattractive? 
□ Yes 
□ No 
12. Did your physical condition make you feel less capable? 
□ Yes 
□ No 
13. Did you feel sorry for yourself? 
□ Yes 
□ No 
14. Did you feel like you complained a lot? 
□ Yes 
□ No 
15. Did you have to ask for help a lot? 
□ Yes 
□ No 
16. Did you feel angry or frustrated about your health or any physical 
condition? 
□ Yes 
□ No 
 
Before your injury, how much were you bothered by the day to day adjustments you were making and the feelings you 
were experiencing in your life? 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
 
 
 

Appendix C: Pre-Injury Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                                Visit Interval:  Pre-injury 
Study #1402557771 
 
v. 07/31/2020 
 
     
WORK ACTIVITIES 
 
Were you working before you injury? 
 
□ No……Were you unable to work because of your health or physical condition? 
 
 
 
□No 
 
 
 
□Yes 
 
□Yes…… (please answer the questions below) 
 
Please answer these questions as they describe your experiences at work before your injury. Before 
your injury . . . 
1. Were you making changes in your job? 
□ Yes 
□ No 
2. Was it more difficult for you to do your job because of your health or 
physical condition? 
□ Yes 
□ No 
3. Were you slow at your job because of your health or physical condition? 
□ Yes 
□ No 
4. Did you take more breaks because of your health or physical condition? 
□ Yes 
□ No 
 
Before your injury, how much were you bothered by problems with work activities, because of your physical condition? 
(Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
 
 

Appendix D: Follow-up Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                      Visit Interval:  6month  1 year   
Study #1402557771 
 
v. 07/31/2020 
 
     
 
Musculoskeletal Function Assessment 
 
We are interested in finding out how you are managing with your injury or arthritis this week.   
 
Please answer "YES" or "NO" to each question by putting a check in the box □ next to the 
question.  If the question was true for you and is related to your injury or arthritis, choose 
"YES".  If the question was not true for you and is not related to your injury or arthritis, choose 
"NO". 
 
If you wish to comment on any of the questions, please use the space in the margins.  Please 
answer all questions, even though some of the questions may not apply to your injury or 
arthritis. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Appendix D: Follow-up Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                      Visit Interval:  6month  1 year   
Study #1402557771 
 
v. 07/31/2020 
 
     
 
ACTIVITIES USING YOUR ARMS OR LEGS 
 
This first set of questions is about changes or problems you may have using your arms or legs to do such 
things as reaching, walking, and carrying. This week, because of your injury or arthritis . . . 
1. Are you able to walk? 
□ Yes 
□ No 
2. Do you feel unsteady on your feet? 
□ Yes 
□ No 
3. Is it difficult for you to reach up high? 
□ Yes 
□ No 
4. Do you straighten or bend your arm(s) completely? 
□ Yes 
□ No 
5. Do you straighten or bend your leg(s) completely? 
□ Yes 
□ No 
6. Do you pivot? 
□ Yes 
□ No 
7. Do you climb up and down ladders? 
□  Yes 
□ No 
8. Do you have to rest often when walking? 
□  Yes 
□ No 
9. Do you avoid stairs? 
□  Yes 
□ No 
10. Do you stand for long periods of time? 
□  Yes 
□ No 
11. Was it hard for you to get moving after you’d been sitting or lying down? □  Yes 
□ No 
12. Do you always walk with a limp? 
□  Yes 
□ No 
13. Do your legs sometimes lock or give-way? 
□  Yes 
□ No 
14. Do you have trouble getting in or out of a low chair? 
□  Yes 
□ No 
15. Do you have trouble getting in or out of bed? 
□  Yes 
□ No 
16. Do you kneel? 
□  Yes 
□ No 
17. Do you pick up things from the floor? 
□  Yes 
□ No 
18. Do you run at all? 
□  Yes 
□ No 
19. Do you have trouble getting in or out of a car? 
□  Yes 
□ No 
20. Had you stopped using public transportation because of your physical 
condition? 
□  Yes 
□ No 
 
How much are you bothered by problems you are now having using your arms or legs?  
(Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 

Appendix D: Follow-up Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                      Visit Interval:  6month  1 year   
Study #1402557771 
 
v. 07/31/2020 
 
     
ACTIVITIES USING YOUR HANDS 
 
The following questions are about activities using your hands. This week, because of your injury or 
arthritis . . . 
1. Do you have difficulty squeezing things? 
□ Yes 
□ No 
2. Do you have difficulty making a tight fist? 
□ Yes 
□ No 
3. Is it hard for you to put your hand in your pocket? 
□ Yes 
□ No 
4. Do you have difficulty turning knobs or levers (for example, opening doors, 
rolling down car windows)? 
□ Yes 
□ No 
5. Do you have trouble holding a book? 
□ Yes 
□ No 
6. Do you have difficulty writing or typing? 
□ Yes 
□ No 
7. Do you have trouble opening medicine bottles or jars? 
□  Yes 
□ No 
 
How much are you bothered by problems you are now having using your hands? (Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
WORK AROUND YOUR HOME 
 
These questions are about activities around your home, including such things as cooking, cleaning, 
maintenance, or repairs. This week, because of your injury or arthritis . . . 
1. Do you need help with housework or yard work? 
□ Yes 
□ No 
2. Do you do as much housework or yard work? 
□ Yes 
□ No 
3. Do you do household chores but find that it takes more effort? 
□ Yes 
□ No 
4. Do you mop or sweep or vacuum? 
□ Yes 
□ No 
5. Is scrubbing a pan or dish difficult? 
□ Yes 
□ No 
6. Do you need someone to cook for you? 
□ Yes 
□ No 
7. Does it take you longer to do household chores? 
□  Yes 
□ No 
8. Is it difficult for you to shop for groceries or other thing? 
□  Yes 
□ No 
9. Have you stopped doing car, house, or maintenance repairs because of 
your injury or arthritis? 
□  Yes 
□ No 
 
How much are you bothered by problems you are now having doing work around your home? (Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 

Appendix D: Follow-up Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                      Visit Interval:  6month  1 year   
Study #1402557771 
 
v. 07/31/2020 
 
     
 
SELF CARE ACTIVITIES 
 
The following questions are about taking care of yourself. This week, because of your injury or arthritis . 
. . 
1. Do you wear things that are easier to get into? 
□ Yes 
□ No 
2. Do you sometimes need help from others to get dressed? 
□ Yes 
□ No 
3. Do you struggle with buttons, snaps, hooks, zippers? 
□ Yes 
□ No 
4. Do you have trouble pulling clothes on over your head? 
□ Yes 
□ No 
5. Is it difficult for you to put on shoes, socks, or stockings? 
□ Yes 
□ No 
6. Is it a chore for you to dress because it took so long? 
□ Yes 
□ No 
7. Is it difficult to brush your teeth? 
□  Yes 
□ No 
8. Do you have a difficult time cutting your fingernails? 
□  Yes 
□ No 
9. Do you need help keeping yourself clean after going to the bathroom? 
□  Yes 
□ No 
10. Is it difficult for you to get on or off the toilet? 
□  Yes 
□ No 
11. Is it hard for you to get in or out of the bathtub or shower? 
□  Yes 
□ No 
12. Do you sit while showering? 
□  Yes 
□ No 
13. Do you need help washing yourself? 
□  Yes 
□ No 
14. Do you need help eating? 
□  Yes 
□ No 
15. Is it hard for you to cut food? 
□  Yes 
□ No 
16. Are you stuck at home? 
□  Yes 
□ No 
17. Have you stopped going out by yourself? 
□  Yes 
□ No 
18. Have you stopped driving because of your physical condition? 
□  Yes 
□ No 
 
 
This week, because of your injury or arthritis, how much were you bothered by problems caring for yourself? (Please 
check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
 
 

Appendix D: Follow-up Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                      Visit Interval:  6month  1 year   
Study #1402557771 
 
v. 07/31/2020 
 
     
SLEEP AND REST 
 
These questions are about changes or problems you may be experiencing with sleep and rest. This 
week, because of your injury or arthritis . . . 
1. Are you tired all of the time? 
□ Yes 
□ No 
2. Do you have trouble falling asleep at night? 
□ Yes 
□ No 
3. Do you have difficulty sleeping the whole night? 
□ Yes 
□ No 
4. Is it hard for you to get comfortable to sleep? 
□ Yes 
□ No 
5. Do you wake up sooner than you would like? 
□ Yes 
□ No 
6. Do you have disturbing dreams? 
□ Yes 
□ No 
 
How much are you bothered by problems you are now having with sleep and rest? (Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
LEISURE and RECREATIONAL ACTIVITIES 
 
We would also like to know about changes or problems you are having with leisure time or recreational 
activities. These activities may include such things as hobbies, sports, crafts, gardening, aerobics, or 
volunteering. This week, because of your injury or arthritis . . . 
1. Is your physical fitness worse because of your health or physical 
condition? 
□ Yes 
□ No 
2. Do you do less of your usual physical recreational activities because of 
your health or physical condition? 
□ Yes 
□ No 
3. Have you stopped doing all of your usual physical recreational activities? 
□ Yes 
□ No 
4. Are you doing fewer leisure activities (such as hobbies, crafts, gardening, 
card playing, going out with friends) because of your health or physical 
condition? 
□ Yes 
□ No 
 
 
 
How much are you bothered by problems you are now having with leisure and recreational activities? (Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
 
 

Appendix D: Follow-up Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                      Visit Interval:  6month  1 year   
Study #1402557771 
 
v. 07/31/2020 
 
     
RELATIONSHIPS: FAMILY and FRIENDS 
 
These questions are about your relationships with family, friends, and other important people in your 
life. This week, because of your injury or arthritis . . . 
1. Is there a strain in your relationships with either your friends or family? 
□ Yes 
□ No 
2. Do you feel you just don’t want to be around anybody? 
□ Yes 
□ No 
3. Is it hard for you to get either your family or friends to help you do things? □ Yes 
□ No 
4. Are you lonely? 
□ Yes 
□ No 
5. Do you feel that either your friends or family had shied away from you? 
□ Yes 
□ No 
6. Do you often act irritable towards those around you (for example, snap at 
people, give sharp answers, criticize easily)? 
□ Yes 
□ No 
7. Do you miss being with either your friends or family? 
□ Yes 
□ No 
8. Do you feel like being less intimate? 
□ Yes 
□ No 
9. Has your sexual life changed? 
□ Yes 
□ No 
10. Do you enjoy sex less? 
□ Yes 
□ No 
 
How much are you bothered by problems you are now having with your friends, family, and other important people in 
your life? (Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
THINKING 
 
These questions are about thinking, concentrating, or remembering. This week, because of your injury 
or arthritis . . . 
1. Does it take you a long time to figure things out? 
□ Yes 
□ No 
2. Do you have problems with concentration? 
□ Yes 
□ No 
3. Are you confused and scattered? 
□ Yes 
□ No 
4. Are you more forgetful? 
□ Yes 
□ No 
 
How much are you bothered by problems you are now having thinking, concentrating, and remembering?  (Please check 
one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 

Appendix D: Follow-up Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                      Visit Interval:  6month  1 year   
Study #1402557771 
 
v. 07/31/2020 
 
     
 
LIFE CHANGES and FEELINGS 
 
These questions are about the day to day adjustments you may be making because of your injury or 
arthritis and feelings  you may be having about your experiences. This week, because of your injury or 
arthritis . . . 
1. Do you sometimes use your physical condition as an excuse not to do 
things? 
□ Yes 
□ No 
2. Do you have to concentrate when using your injured limb or arthritic 
joints? 
□ Yes 
□ No 
3. Do you avoid using your injured limb or arthritic joints? 
□ Yes 
□ No 
4. Do you protect your injured limb or arthritic joints? 
□ Yes 
□ No 
5. Do you think everything will work out in the long run? 
□ Yes 
□ No 
6. Do you accept your current situation? 
□ Yes 
□ No 
7. Do you feel everything is back to normal? 
□ Yes 
□ No 
8. Do you feel your life has changed quite a bit? 
□ Yes 
□ No 
9. Are you getting worse? 
□ Yes 
□ No 
10. If you do too much in one day, does it affect what you do the next day? 
□ Yes 
□ No 
11. Do you feel disabled, even though you may look fine to others? 
□ Yes 
□ No 
12. Do you feel useless? 
□ Yes 
□ No 
13. Do you feel unattractive? 
□ Yes 
□ No 
14. Does your injury or arthritis make you feel less capable? 
□ Yes 
□ No 
15. Do you feel sorry for yourself? 
□ Yes 
□ No 
16. Do you feel like you complained a lot? 
□ Yes 
□ No 
17. Do you have to ask for help a lot? 
□ Yes 
□ No 
18. Do you feel angry or frustrated that you have this injury or arthritis? 
□ Yes 
□ No 
 
How much are you bothered by the day to day adjustments you are making in your life and the feelings you are now 
experiencing, because of your injury or arthritis? (Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
 

Appendix D: Follow-up Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                      Visit Interval:  6month  1 year   
Study #1402557771 
 
v. 07/31/2020 
 
     
WORK ACTIVITIES 
Are you working now? 
 
□ No……Are you unable to work because of your injury or arthritis? 
 
 
 
□No (Please skip to the next section) 
 
 
 
□Yes (Please skip to the next section) 
 
□Yes…… (Please answer the questions below) 
 
Please answer these questions as they describe your experiences at work. This week, because of your 
injury or arthritis . . . 
1. Are you making changes in your job? 
□ Yes 
□ No 
2. Is it more difficult for you to do your job now? 
□ Yes 
□ No 
3. Are you slower at your job? 
□ Yes 
□ No 
4. Do you take more breaks? 
□ Yes 
□ No 
 
How much are you bothered by problems you are now having with work activities, because of your injury or arthritis? 
(Please check one) 
□  1 
Not at 
all bothered 
□  2 
A little 
bothered 
□  3 
Somewhat 
bothered 
□  4 
Quite 
bothered 
□  5 
Extremely 
bothered 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Appendix D: Follow-up Musculoskeletal Function Assessment (MFA) 
 
Subject ID:_________________                      Date:____/____/____                      Visit Interval:  6month  1 year   
Study #1402557771 
 
v. 07/31/2020 
 
     
If you have completed this survey before, please answer the following three questions.  If you 
are completing this survey for the first time, please skip them. 
 
1. Have you had any injuries or other important changes in your health since you completed the last survey? 
□ No 
□ Yes… If yes, please list whatever injuries or health changes you have had: 
________________________________________________________________________
________________________________________________________________________ 
 
2. Have you had any surgeries or hospitalizations since you completed the last survey? 
□ No 
□ Yes… If yes, please list whatever injuries or health changes you have had: 
________________________________________________________________________
________________________________________________________________________ 
 
3. How is your injury or arthritis now, compared to when you completed the last  survey? (Check one) 
Much worse……………..□ 
Slightly worse……………□ 
About the same..………□ 
Slightly better……………□ 
Much better……..………□ 
 

Appendix E: 2 Minute Walk Test 
 
Subject ID:_________________ 
                       
Study #1402557771 
 
v. 07/31/2020 
 
     
 
Date: _____/_____/_____ 
 
Assistance Level: _____________________           02 %:______________ 
Assistive Device Used: ____________________________ Distance ambulated in 2 minutes: 
_______________ Vitals before test: HR: _____   BP: _____/_____ O2 _____ 
Vitals after test: HR: _____   
BP: _____/______ O2 _____  
Pt unable to complete test due to:  
□  Pending OR/on bed rest  
□ Physical inability to complete due clinical indication such as pain/decrease in vitals. 
Completed by: _______________________ 
__________________________________________________________________________________________
_ 
Date: _____/_____/_____ 
 
Assistance Level: _____________________           02 %:______________ 
Assistive Device Used: ____________________________ Distance ambulated in 2 minutes: 
_______________ Vitals before test: HR: _____   BP: _____/_____ O2 _____ 
Vitals after test: HR: _____   
BP: _____/______ O2 _____  
Pt unable to complete test due to:  
□  Pending OR/on bed rest  
□ Physical inability to complete due clinical indication such as pain/decrease in vitals. 
Completed by: _______________________ 
__________________________________________________________________________________________
_ 
Date: _____/_____/_____ 
 
Assistance Level: _____________________           02 %:______________ 
Assistive Device Used: ____________________________ Distance ambulated in 2 minutes: 
_______________ Vitals before test: HR: _____   BP: _____/_____ O2 _____ 
Vitals after test: HR: _____   
BP: _____/______ O2 _____  
Pt unable to complete test due to:  
□  Pending OR/on bed rest  
□ Physical inability to complete due clinical indication such as pain/decrease in vitals. 

Appendix E: 2 Minute Walk Test 
 
Subject ID:_________________ 
                       
Study #1402557771 
 
v. 07/31/2020 
 
     
Completed by: _______________________ 
__________________________________________________________________________________________
_ 

Appendix F: Adverse Event 
 
Subject ID:_________________  
                                                             Report Date:_____/_____/_____    
Interval:   2 weeks   6 weeks   3months   6 months   9months    1 year                      
Study #1402557771 
 
v. 07/31/2020 
 
     
Date of event: _____/_____/_____    
 
   Osteomyelitis 
 
     Urinary tract infection 
 
   Pneumonia  
 
 
     Renal insufficiency 
    Cardiac ischemia  
 
     Myocardial infarction 
     Deep venous thrombosis     Reoperation 
 
 
    Re-hospitalization (___/___/___) 
     Infection   
 
 
 
 
 
 
 
 Superficial (cellulitis treated with oral antibiotics) 
 Deep (requires IV antibiotics or surgical debridement) 
 
     Other:  ________________________________________________________________ 
 
Please list any details of event: ___________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
 
Event related to treatment? 
 
 
 Related  
 Probably Related  Possibly Related  
 Not Related 
 
Classification of AE: 
 
 Expected 
 
 Unexpected 
 
Serious (check below) 
 
 
Requires/prolongs inpatient hospitalization  
 
 
 Immediately life-threatening 
 
 
 
Permanently disabled  
 
 
 Fatal 
 
Outcome:  
 
 Resolved ….date resolved _____/_____/_____ 
 
 Resolved with impairment….date resolved _____/_____/_____ 
 
 
Degree of impairment:  Mild    Moderate  Severe 
 
 Ongoing 

Appendix G: Protocol Deviation 
 
Subject ID:_________________  
                                                             Report Date:_____/_____/_____    
Study #1402557771 
 
v. 07/31/2020 
 
     
 
1. Date of deviation: _____/_____/_____ 
2. Please describe protocol deviation: ________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________ 

Appendix H: Escape Criteria 
 
Subject ID:_________________  
                                                             Report Date:_____/_____/_____    
Study #1402557771 
 
v. 07/31/2020 
 
     
 
1. Transfusion Time:  ____:____   
 
2. Reason patient was transfused:  
 
   Patient has any of the following symptoms at rest: chest pain, shortness of breath, dizziness 
 
   Patient has a mean arterial pressure less than 50 mmHg that is not responsive to fluid resuscitation 
 
   At any time the patient’s heart rate increases by more than 30% above baseline while under anesthesia 
 
   The patient’s urine output drops to less than 0.5 mL/kg/hour and remains decreased despite adequate 
rehydration with fluids 
 
   Any objective evidence of cardiac ischemia including the following: EKG changes such as ST depression, 
an elevation of serum cardiac markers, a base deficit greater than 6, lactate greater than 2.5 that does not 
respond to fluid resuscitation 
 
   A decrease in systolic blood pressure by 10% or more with exercise (physical therapy) that does not 
improve with fluid resuscitation 
 
   Uncontrolled source of hemorrhage 
 
   Asymptomatic- Hgb dropped below randomization threshold 
 
 
 
 
3. Lowest Hgb prior to transfusion: _______ g/dL 
 
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________ 
 

Appendix H: Escape Criteria 
 
Subject ID:_________________  
                                                             Report Date:_____/_____/_____    
Study #1402557771 
 
v. 07/31/2020 
 
     
 

Appendix I: Length of Stay 
 
Subject ID:_________________  
                                                             Report Date:_____/_____/_____    
Study #1402557771 
 
v. 07/31/2020 
 
     
 
 
 
1. Date of hospital admission: ______/______/______ 
 
 
2. Date of hospital discharge: 
______/______/______ 
 
 
3. Length of hospital stay: 
______days 

Appendix J: American Academy of Orthopaedic Surgeons Abstract February 2011 
San Diego, CA (Podium Presentation) 
 
 
 
  
Study #1402557771 
 
v. 07/31/2020 
 
     
 
Does Anemia or Transfusion Increase the Risk of Complications in Orthopaedic Trauma Patients? 
 
Introduction: Transfusion of young, healthy, asymptomatic Orthopaedic trauma patients is routine at many 
institutions due to concerns for anemia.  The purpose of this study is to assess whether anemia, with or without 
allogeneic blood transfusion, contributes to an increased complication rate in healthy orthopaedic trauma 
patients and whether the transfusion itself might be an independent risk factor for a complication. 
 
Methods:  A retrospective review of 104 patients treated at a level-one trauma center from September 2006- 
February 2009 was conducted.  Inclusion criteria were patients 18-50 years of age, a hemoglobin concentration 
of 9.0 g per deciliter (g/dL) or less at any time during their admission.  Head injured patients or patients with 
history or pulmonary or cardiac conditions were excluded.  The patients were initially divided into two cohorts 
by their lowest hemoglobin level prior to first transfusion of < 7.0 (g/dl) and >7.0 (g/dl); this was followed by 
further division depending on whether the patients were transfused.  Logistic regression analysis was 
performed. 
 
Results:   There was no increased risk for complication related to anemia itself (p=0.3).  However, there was  a 
significant risk for complication related to transfusion (p<0.01); furthermore, there was a dose-dependent effect 
with complication risk increasing with each unit transfused (p=0.02).  Other factors such as age, injury severity 
score (ISS), and gender were considered and when adjusted did not change these results.   
 
Conclusion: In young, healthy Orthopaedic trauma patients anemia does not appear to act as an independent risk 
factor for complications; however, allogeneic blood transfusion does appear to be a significant independent risk 
factor for complication and has a dose-dependent effect. 
 
 
 
 
 
 

Appendix K: American Journal of Orthopaedics, 2015 
 
  
Study #1402557771 
 
v. 07/31/2020 
 
     
 
Does Anemia or Transfusion Increase the Risk of Complications in Orthopaedic Trauma Patients? 
Mullis BH, Fisk E, Weaver D, Zhao Q, Daggy J  Indiana University School of Medicine Department of 
Orthopaedics 
 
Introduction: Transfusion of young, healthy, asymptomatic Orthopaedic trauma patients is routine at many 
institutions due to concerns for anemia.  The purpose of this study was to assess whether anemia, with or 
without allogeneic blood transfusion, contributed to an increased complication rate in healthy Orthopaedic 
trauma patients and whether the transfusion itself might be an independent risk factor for a complication. 
 
Methods:  A retrospective review of 104 patients treated at a level 1 trauma center by a single surgeon from 
September 2006- February 2009 was conducted.  Inclusion criteria were patients 18-50 years of age and a 
hemoglobin concentration of 9.0 g per deciliter (g/dL) or less at any time during their admission.  Patients with 
head injury, pregnancy, or patients with a pre-existing history of pulmonary, cardiac, or renal conditions were 
excluded.  The patients were initially divided into two cohorts by their lowest hemoglobin level prior to first 
transfusion of < 7.0 (g/dl) and >7.0 (g/dl); this was followed by further division depending on whether the 
patients were transfused.  Logistic regression analysis was performed.  Patients’ charts were reviewed for 
complications extending through a one-year period after initial discharge from the inpatient service.  Patients 
who had not received follow-up treatment through a known outpatient clinic were contacted by telephone to 
ascertain outcome.  Overall, 5 out of 104 patients were lost at one-year follow-up.  Among other variables, 
postoperative complications were recorded as our primary outcome.  Superficial wound infection was defined 
as cellulitis within one year requiring oral antibiotics; deep wound infection was defined as any infection within 
1 year of injury which required intravenous antibiotics or surgical debridement in the operating room.   
Complications included (not all were found but the following were specifically searched) superficial infection 
(defined as cellulitis requiring oral antibiotics), deep infection (defined as requiring intravenous antibiotics or 
surgical debridement), urinary tract infection, pneumonia, pulmonary embolism, deep venous thrombosis, acute 
renal failure or insufficiency, nonunion, delayed union, compartment syndrome, osteomyelitis, nerve palsy, 
anoxic brain injury, cardiac ischemia or infarct, pancreatitis, or death. 
 
Results:   There was no increased risk for complication related to anemia itself (p=0.3).  However, there was a 
significant risk for complication related to transfusion (p<0.01); furthermore, there was a dose-dependent effect 
with complication risk increasing with each unit transfused (p=0.02).  Other factors such as age, injury severity 
score (ISS), and gender were considered and when adjusted did not change these results.   
 
Conclusion: In young, healthy Orthopaedic trauma patients anemia does not appear to act as an independent 
risk factor for complications; however, allogeneic blood transfusion does appear to be a significant independent 
risk factor for complication and has a dose-dependent effect.  Based on our findings from this retrospective 
study, we are designing a multi-specialty prospective study on Orthopaedic Trauma patients at our institution to 
determine if transfusion simply acts as a marker for patients at higher risk for complication due to injury or if 
transfusion might contribute directly to these complications.