Operative and Non-operative Treatment of Traumatic Arthrotomies: A Prospective Observational Study
Conditions: Traumatic Arthrotomy
Sponsor: Wake Forest University Health Sciences

Proposal for Carolinas Medical Center IRB Approval 
 
Title of the Study:  Operative and Non-operative treatment of Traumatic 
Arthrotomies: A Prospective Observational Study 
 
Date:  January  10th, 2019 
Version: 4 
Abstract 
For the last 70 years, orthopaedic dogma has dictated that all injuries that penetrate 
the joint capsule require formal irrigation and debridement in the operating room to 
minimize the risk of developing septic complications.  The literature supporting this 
practice is sparse and stems primarily from wartime injuries that may not be 
generalizable to the smaller, less contaminated arthrotomies seen in the civilian 
population.  Despite the classical teaching of all traumatic arthrotomies requiring 
irrigation, debridement, and closure in the operating room, numerous surgeons 
around the country are beginning to treat small traumatic arthrotomies without 
surgery.  The purpose of this study is to evaluate the cost of treatment as well as 
incidence of adverse events, such as the development of septic arthritis, in patients 
undergoing operative and non-operative treatment of traumatic arthrotomies.   
 
Background and Rationale 
 
Soft tissue wounds around joints are common injuries that are carefully 
evaluated to identify intra-articular extension.  Wound exploration, imaging, and 
intra-articular saline load injections are commonly utilized to diagnose the presence 
of a traumatic arthrotomy.   The reason for such diligence is that the treatment is 
dramatically different for a wound that violates the joint compared to one that does 
not.  As opposed to local wound care for simple soft tissue wounds, traumatic 
arthrotomies are thought to require formal irrigation and debridement in the 
operating room to minimize the risk of developing septic arthritis.  
 
Septic Joints 
An injury that penetrates the joint capsule and synovium violates the body’s 
natural barriers that protect the joint from external pathogens.   Microorganisms 
from the environment may enter the joint by direct inoculation or by contiguous 
spread through the now perforated barrier.  By bringing patients to the operating 
room for formal irrigation and debridement, orthopaedic surgeons are theoretically 
attempting to minimize the burden of contamination and repair the body’s natural 
barriers to reduce the risk of developing an intra-articular infection.  Septic arthritis 
is an orthopaedic emergency that can result in severe cartilage damage causing 
long-term joint pain, stiffness, and potentially auto-fusion (Chander S, Curr Infect Dis 
Rep, 2011).  If not dealt with in a timely manner, intra-articular infections can result 
in significant long-term disability, and in extreme cases, can result in overwhelming 
sepsis and death (Chander S, Curr Infect Dis Rep, 2011). 
 
Orthopaedic Dogma 

Clearly, minimizing the risk of developing septic arthritis is important to 
every orthopaedic surgeon.   Over sixty years ago, Hampton published his 
observation of a high rate of septic complications in combat injuries that violated 
the joint (Hampton OP, JBJS, 1946).  Since then, orthopaedic dogma has dictated that 
all injuries that violate the joint necessitate formal irrigation and debridement in 
order to minimize the risk of infectious complications.   The literature on the topic is 
sparse and stems primarily from wartime observations in which the injuries 
sustained were commonly associated with high levels of contamination, intra-
articular fractures, retained foreign bodies, and delayed treatment (Marvel JE, CORR, 
1977).  The characteristics of these injuries may limit the generalizability of these 
observations to the civilian population, especially for small, mildly contaminated 
arthrotomies without associated fracture or retained foreign body. 
To date, no studies have prospectively evaluated the benefits of operative 
irrigation and debridement of traumatic arthrotomies compared to non-operative 
observation with antibiotics.  A single study published in 1975 by Patzakis and 
others showed that patients with open joint injuries treated with operative 
irrigation and debridement had an infection rate of 2.1%, a value significantly lower 
than was previously observed in the non-operative cohort of combat injuries 
(Patzakis MJ, JBJS, 1975) (Hampton OP, JBJS, 1946) (Marvel JE, CORR, 1977).  There 
is little question that large and heavily contaminated arthrotomies benefit from 
formal irrigation and debridement, but it is unclear if this benefit can extrapolated 
to smaller, less contaminated injuries.  Nevertheless, orthopaedic surgeons continue 
to debride and irrigate open joints regardless of the burden of contamination or size 
of arthrotomy. 
 
Small Arthrotomies are Commonly Missed Injuries 
In an effort to identify and treat as many traumatic arthrotomies as possible, 
orthopaedic surgeons began looking for additional techniques to aid in their 
diagnosis.  After it’s introduction in 1975, saline arthrograms quickly became the 
gold standard for the diagnosis of small traumatic arthrotomies (Patzakis and Voit).   
This doctrine was called into question by Tornetta and others when they showed 
that saline load arthrograms, as they were commonly performed, had a sensitivity of 
only 43% (Tornetta P 3rd, CORR, 2008).   Two years later, Nord and others 
recommended using 155-ml of saline to diagnose 95% of arthrotomies, a volume 
more than double what was previous used in clinical practice and not easily 
tolerated by most patients (Nord RM, JBJS, 2009).  Most recently, Metzger et. al. 
demonstrated a false-negative rate of 67% when using 180-mL of saline for their 
arthrograms, a volume far beyond what would be tolerated in a conscious patient 
(Metzger P, JOT, Epub).  Despite missing up to half of all small traumatic 
arthrotomies for the last 40 years, there has not been an outbreak in patients 
returning with septic arthritis from missed arthrotomies.  The absence of such an 
occurrence raises the question if it is even necessary to formally debride and 
irrigate small traumatic arthrotomies in the operating room at a great cost to the 
patient.   
 
Costs of Arthrotomy 

  
Despite the relative dearth of evidence supporting the practice of formally 
irrigating and debriding all open joint injuries, significant healthcare expenditures 
and additional risks of general anesthesia are undertaken to address this problem.  
Although the administration of general anesthesia has become extremely safe, it still 
carries the risk of serious consequences such as heart attack, stroke, and even death 
(Lanier WL, Am Surg, 2006)(Botney R, Int J Radiat Oncol Biol Phys, 2008).  Patients 
with multiple medical comorbidities are at an even greater risk of a serious 
perioperative complication (Wolters U, Br J Anaesth, 1996).  
In addition to the risks of undergoing anesthesia, there are significant costs 
associated with any operation.  A patient diagnosed with an isolated traumatic knee 
arthrotomy can expect to leave the hospital with a bill of at least $15,000 based on 
conservative estimates provided by the Department of Research Finance at 
Carolinas Medical Center.   In an era where healthcare costs are spiraling out of 
control, determining which interventions are efficacious will be paramount in 
shaping healthcare resource utilization and maintaining long-term sustainability. 
 
Conclusion 
 
To our knowledge, there is no evidence to support the practice of 
prophylactic irrigation and debridement of traumatic arthrotomies that would 
otherwise be amenable to treatment in the emergency department. It is the opinion 
of the senior authors of this study, who are both experienced orthopaedic 
traumatologists at high-volume level 1 trauma centers, that small, mildly 
contaminated traumatic arthrotomies could be treated with antibiotics and close 
follow-up alone, if they are amenable to closure in the emergency department.   
Instead of a hospital admission and operative procedure, these patients could be 
safely discharged from the emergency department with local wound care and 
antibiotics alone resulting in significant healthcare savings and minimizing the risks 
of undergoing general anesthesia and a surgical procedure. 
 
Research Plan 
 
Specific Aim 1:  To compare the cost of medical care in patients with traumatic 
arthrotomies treated with surgical irrigation and debridement versus non-operative 
treatment with local wound care. 
 
Hypothesis 1:  Patients with traumatic arthrotomies will have an average 
hospital bill of $15,000 less than those treated with surgery. 
 
Specific Aim 2: To determine the incidence of developing a septic arthritis in 
patients with a non-operatively treated traumatic arthrotomy. 
 
Hypothesis 2:  Non-operative treatment of small traumatic arthrotomies will 
have an extremely low rate (<10%) of subsequent septic arthritis over a 3-
month period. 
 

Specific Aim 3:  To determine the incidence of developing a septic arthritis in 
patients with operative treatment of a traumatic arthrotomy. 
 
Hypothesis 3:  Operative treatment of traumatic arthrotomies will have an 
extremely low rate (<5%) of subsequent septic arthritis over a 3-month 
period. 
 
Specific Aim 4: To determine the need for additional surgery (ex: foreign body 
removal) in patients with a non-operatively treated traumatic arthrotomy. 
 
Hypothesis 4:  Non-operative treatment of small traumatic arthrotomies will 
have an extremely low rate subsequent surgery over a 6-month period. 
 
Specific Aim 5: To provide a description of traumatic arthrotomies successfully 
treated non-operatively. 
 
Hypothesis 5:  Arthrotomies will be less than 1 cm with a soft tissue injury 
amenable to closure in the ED.   Arthrotomies will be more likely to be due to 
GSW’s and scraping mechanisms rather than direct penetration. 
 
 
 
 
Study Design 
Prospective Multi-center Observational Cohort 
Retrospective chart review 
 
Study Population 
Inclusion Criteria 
1. Any patient 18 and older with a traumatic arthrotomy (of any major joint) 
confirmed by saline load test, direct visualization of a capsular rent or intra-
articular contents, or air in the joint on CT or radiographs. 
a. Major Joints Include: 
i. Knee 
ii. Elbow 
iii. Wrist 
iv. Shoulder 
v. Hip 
vi. Ankle 
Exclusion Criteria 
 
1. Patients who will have severe problems with maintaining follow-up 
 
 
 
 

Method for Selecting Samples 
Potential patients will be prospectively identified at the time of the initial 
consultation or at the first clinic follow-up appointment based on the diagnosis of a 
traumatic arthrotomy (Diagnostic criteria noted in inclusion criteria above).   
Patients will be screened by their inclusion and exclusion criteria, and if met will be 
considered for enrollment in the study. 
 
Retrospective chart review 
The study will also conduct a retrospective chart review of patients who presented 
with a traumatic arthrotomy during the enrollment period., however were unable to 
be reached for consent after multiple attempts over a period of two years. 
Information about injury and treatment outcomes will be collected from the medical 
record.  
 
Representativeness of the Sample 
The study population will be representative of the typical trauma population. 
Patients of all ages, genders, ethnicities, and backgrounds will be included in this 
study.  Based on previous clinical series of patients at our institution, we expect that 
70% of our patients will be men and 25% minority patients.   
 
 
Definition of Variables 
Outcome Variables 
• Primary Outcomes 
o Cost of treatment 
o Adverse Events 
 Development of septic arthritis 
 Return to operating room for any reason (ie: foreign body 
removal) 
 Rehospitalization 
 Development of osteomyelitis 
• Secondary Outcomes 
o Superficial wound infection 
 Extra-articular infection requiring a prolonged course of 
antibiotics or local wound care. 
o Pain 1 – 10 Scale 
 Current 
 Worst in last 24 hours 
 At rest 
 Bearing weight 
 Ambulating 
o Return to work or previous level of activity 
 
Demographic Variables and Covariates 
• Demographic Information 

o Age 
o Gender 
o BMI 
o Mechanism of injury 
o Smoking Status 
o Comorbidities 
o Employment status 
o Workers compensation status 
• Additional Injuries 
• Arthrotomy Characteristics 
o Mechanism of arthrotomy 
 Abrasion 
 Laceration 
 Puncture 
 GSW 
 Blast injury 
o Degree of contamination  
o Size of arthrotomy (mm) 
o Shape of arthrotomy 
o Method of Diagnosis 
 Visualization 
 Air on CT or radiograph 
 Saline load 
• Treatment Characteristics 
o Antibiotics administered 
 Timing 
 Duration 
o Indication for Surgery 
 OR for additional injury 
 Intra-articular fracture requiring operative fixation 
 Heavily contaminated 
 Intra-articular loose body 
 Large arthrotomy 
 Intra-articular hardware 
 
Potential Confounders 
As a prospective observational study, the patient’s treatment will not be 
altered by their inclusion in the study.   No guidelines will be provided to influence 
the treating surgeons’ decision making.  All surgeons will have treated patients 
based on their own expert opinion and biases, which will undoubtedly differ 
between surgeons.  The purpose of the study is to show that some traumatic 
arthrotomies can be treated non-operatively based on surgeon discretion, and 
having a variety of different arthrotomies will add to the descriptive nature of the 
study.   

The observational nature of this study will introduce a selection bias based 
on the surgeon’s comfort level of treating traumatic arthrotomies non-operatively.  
Larger and more heavily contaminated arthrotomies will be far more likely to be 
treated operatively compared to smaller, less contaminated arthrotomies.  Any 
comparisons made between operative and non-operative treatment will have to be 
made between a matched cohort of arthrotomies of similar severity. 
Although the treatment of patients should not be altered by their inclusion in 
the study, the possibility of a Hawthorne (observer) effect bias exists.  The treating 
surgeon’s decision making may potentially be altered by participation in this study. 
 
 
 
Patient Safety 
 
Patients involved in the study will not have their medical care altered in any 
way by their participation.  A data safety monitor will be appointed to periodically 
assess for adverse events.  .   
 
 
Methods 
Patient Identification and Enrollment 
Patients will be identified at the time of the initial consultation or first clinic 
follow-up visit based on the presence of a traumatic arthrotomy, of any major joint, 
based on the criteria outlined above.  Patients meeting the inclusion and exclusion 
criteria will be deemed eligible for the study.  Eligible patients will be approached 
by a member of the treatment team to further discuss the study.  If the patient 
agrees, a member of the research staff will discuss the study in greater detail and 
obtain informed consent.   
 
Intervention 
There will be no alterations in patient care by their inclusion in the study.   
The attending surgeon will determine the treatment plan, follow-up frequency, and 
follow-up duration.  The need for additional surgery will also be determined by the 
attending surgeon.  The development of septic arthritis or need to proceed to the 
operating room for foreign body removal will be deemed as adverse events and will 
be reported to the data safety monitor as they occur. 
 
Data Collection 
At the initial consultation, patient demographic information, arthrotomy 
characteristics, treatment variables, and additional injuries will be obtained. At each 
follow-up appointments, pain level will be assessed by a member of the treatment 
team and recorded. Patient will complete the VR-12 to assess quality of health at 3 
month after time of their injury. Patients  may be followed prospectively for a total 
of one year after the time of their injury.  Patients released from care prior to their 
one year appointment will be contacted via telephone by a member of the research 
staff to assess final outcomes. The total cost of care, including hospital and office 
charges, will be recorded at the one year mark. Patients still requiring care at the 3 
month visit as a direct result of treatment of their traumatic arthrotomy will 
continue to be followed for a total of one year. 

 
Follow-Up 
A minimum necessary follow-up of 3 months or 1 year for patient requiring 
care as a direct result of treatment of their traumatic arthrotomy.  Patients released 
from care after this time period without developing septic arthritis will be 
considered a successful therapy.   If a patient is discharged from clinic prior to 3 
months or 1 year, a member of the research team will contact the patient by 
telephone or by mail to obtain final follow up information. 
 
 
Data Collection 
All data will be entered into REDCap, a web-based data entry and 
management system that provides logic checks on input and checks for invalid 
entries. Data will be entered continuously as they are collected and stored in 
univariate form. We will also run standard checks for outliers, duplicates and other 
types of errors which may occur within a complex data file. All data files will be 
password protected and hard copies of blinded patient records will be maintained 
in locked cabinets in the research office. 
 
Study Duration 
Patients will continue to be enrolled for 2-years or until 25 patients are 
treated non-operatively, whichever comes first. 
 
Statistical Analysis  
Standard statistical tests will be used.  Descriptive statistics including means and 
standard deviations, or counts and percentages will be reported.   The principal 
analysis will compare cost of care using logisitic regression.  Also, demographic and 
baseline variables will be compared between operative and non-operative patients 
using t-test and chi-square test where applicable. 
A multivariate logistic regression analysis with cost as the dependent variables and 
a dichotomous variable indicating treatment modality will be performed to adjust 
for possible demographic or baseline differences between the two groups. 
Additional regression analysis will be conducted to determine if demographic 
factors, size or contamination or other factors predict poorer outcomes.  A p-value 
of less than 0.05 will be considered statistically significant.    
 
 
 
Citations: 
 
[1] Hampton OP.  The management of penetrating wounds and suppurative arthritis 
of the knee joint in the Mediterranean theater of operations.  J Bone Joint Surg.  
1946;28(4):659-680. 
 
Historical military article. 
 
[2]  Levy AS, Lefkoe TP, Whitelaw GP, Kohler S.  Management of penetrating 
pneutmatic nailgun injuries of the knee.  J Orthop Trauma.  1991;5(1):66-70. 
 

[3]  Patzakis MJ, Dorr LD, Ivler D, Moore TM, Harvey P.  The early management of 
open joint injuries.  J Bone Joint Surg.  1975;57-A(8):1065-1071. 
2.2 percent infection rate?   
 
[4]  Marvel JE, Marsh HO.  Management of penetrating injuries of the knee.  Clin 
Orthop Relat Res.  1977;122:268-272. 
Historic war wounds 
 
[5]Lanier WL.  A three-decade perspective on anesthesia safety.  Am Surg.  
2006;72(11):985-989. 
 
[6]Botney R.  Improving patient safety in anesthesia: a success story? Int J Radiat 
Oncol Biol Phys.  2008;71(1 Suppl):S182-S186. 
 
[7]Wolters U, Wolf T, Stutzer H, Schroder T.  ASA classification and perioperative 
variables as predictors of postoperative outcome.  Br J Anaesth.  1996;77(2):217-
222. 
 
[8]Chander S, Coakley G.  What’s new in the management of bacterial septic 
arthritis?  Curr Infect Dis Rep.  2011;13:478-484. 
 
[9]Tornetta P 3rd, Boes MT, Schepsis AA, Foster TE, Bhandari M, Garcia BS.  How 
effective is a saline arthrogram for wounds around the knee?  Clin Orthop Relat Res.  
2008;466:432-435. 
 
[10]Nord RM, Quach T, Walsh M, Pereira D, Tejwani NC.  Detection of traumatic 
arthrotomy of the knee using the saline solution load test.  J Bone Joint Surg Am.  
2009;91:66-70. 
 
[11]Metzger P, Carney J, Kuhn K, Booher K, Mazurek M.  Sensitivity of the saline load 
test with and without methylene blue dye in the diagnosis of artificial traumatic 
knee arthrotomies.  J Orthop Trauma.  Epub ahead of print. 
 
Traumatic Arthropathy 716.16 (ICD-9) 
Knee Arthroscopy for Infection with Lavage and Drainage 29871 (CPT) 
Knee Arthrotomy with exploration and draining or removal of foreign body (eg. 
Infection)  27310 (CPT) 
 
OR = $8238.70 (1 hr in room time) 
Recovery Room = $871.20 (1 hr) 
Average ER visit = $435.00  
Professional charge for CPT 29871 = $1780.00 
Average room and board per night = $948.00 
Anesthesia fee per unit = $452.75 x 4 units = $1,811.00 
 Total = $14,083.90 (Does not include any Abx or medications)