Operative and Non-operative Treatment of Traumatic Arthrotomies

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT02841644
• Collaborator: (none)
• Enrollment: 180
• Locations: 4
• Actual Duration (Months): 60
• Patients Per Site: 45
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Arthrotomy	Procedure: Operatively treated traumatic arthrotomy; Other: Non-operatively treated traumatic arthrotomy

Detailed Description

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. 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.

Orthopaedic Dogma Clearly, minimizing the risk of developing septic arthritis is important to every orthopaedic surgeon. Over sixty years ago, observation of a high rate of septic complications in combat injuries that violated the joint. 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. 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 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. 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. This doctrine was called into question when they showed that saline load arthrograms, as they were commonly performed, had a sensitivity of only 43%. Two years later, it was 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. Most recently, a study showed 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. 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. Patients with multiple medical comorbidities are at an even greater risk of a serious perioperative complication.

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.

Specific Aims:

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.

2. To determine the incidence of developing a septic arthritis in patients with a non-operatively treated traumatic arthrotomy.

3. To determine the incidence of developing a septic arthritis in patients with operative treatment of a traumatic arthrotomy.

4. To determine the need for additional surgery (ex: foreign body removal) in patients with a non-operatively treated traumatic arthrotomy.

5. To provide a description of traumatic arthrotomies successfully treated non-operatively.

Study Design Prospective Multi-center Observational Cohort

Study Design

• Study Type: Observational
• Actual Enrollment: 180 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Operative and Non-operative Treatment of Traumatic Arthrotomies: A Prospective Observational Study
• Actual Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Traumatic Arthrotomy- Treated Nonoperatively Patient diagnosed with traumatic arthrotomy treated nonoperatively.	Other: Non-operatively treated traumatic arthrotomy; non-operatively treated traumatic arthrotomy.
Traumatic Arthrotomy- Treated Operatively Patient diagnosed with traumatic arthrotomy treated operatively.	Procedure: Operatively treated traumatic arthrotomy; operatively treated traumatic arthrotomy.

Outcome Measures

Primary Outcome Measures

1. Cost of Treatments [12 months]

   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. To estimate cost associated with TAs, total charge data was acquired for all patients treated at the lead site.

2. Complications [12 months]

   Complications were defined as septic arthritis, return to the OR, rehospitalization, and osteomyelitis of the injured joint.

Secondary Outcome Measures

1. Comparing 3-Month Change in Veterans RAND 12-Item Health Survey (VR-12) by Treatment Method [baseline, 3 months]

   The veteran rand 12-tem health survey is used to determine change in health related quality of life to estimate disease burden. It is summarized into two scores, a physical component scores (PCS) (range 0-100) and mental component scores (range- 0-100). Higher score indicate better outcomes.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

1. Major Joints Include: i. Knee ii. Elbow iii. Wrist iv. Shoulder v. Hip vi. Ankle

Exclusion Criteria:

• Patients who will have severe problems with maintaining follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40506
2	Carolinas Medical Center- Main	Charlotte	North Carolina	United States	28204
3	Greenville Health System	Greenville	South Carolina	United States	29605
4	The University of Tennessee Health Science Center	Memphis	Texas	United States	38163

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Joseph Hsu, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 10, 2019

More Information

Publications

• Botney R. Improving patient safety in anesthesia: a success story? Int J Radiat Oncol Biol Phys. 2008;71(1 Suppl):S182-6. doi: 10.1016/j.ijrobp.2007.05.095.
• Chander S, Coakley G. What's New in the Management of Bacterial Septic Arthritis? Curr Infect Dis Rep. 2011 Oct;13(5):478-84. doi: 10.1007/s11908-011-0201-0.
• HAMPTON OP Jr. The management of penetrating wounds and suppurative arthritis of the knee joint in the Mediterranean Theater of Operations. J Bone Joint Surg Am. 1946 Oct;28(4):659-80.
• Lanier WL. A three-decade perspective on anesthesia safety. Am Surg. 2006 Nov;72(11):985-9; discussion 1021-30, 1133-48. Review.
• Levy AS, Lefkoe TP, Whitelaw GP, Kohler S. Management of penetrating pneumatic nailgun injuries of the knee. J Orthop Trauma. 1991;5(1):66-70.
• Marvel JE, Marsh HO. Management of penetrating injuries of the knee. Clin Orthop Relat Res. 1977 Jan-Feb;(122):268-72.
• 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. 2012 Jun;26(6):347-9. doi: 10.1097/BOT.0b013e3182255167.
• 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 Jan;91(1):66-70. doi: 10.2106/JBJS.G.01682.
• Patzakis MJ, Dorr LD, Ivler D, Moore TM, Harvey JP Jr. The early management of open joint injuries. A prospective study of one hundred and forty patients. J Bone Joint Surg Am. 1975 Dec;57(8):1065-70.
• Tornetta P 3rd, Boes MT, Schepsis AA, Foster TE, Bhandari M, Garcia E. How effective is a saline arthrogram for wounds around the knee? Clin Orthop Relat Res. 2008 Feb;466(2):432-5. doi: 10.1007/s11999-007-0006-5. Epub 2008 Jan 10.
• Wolters U, Wolf T, Stützer H, Schröder T. ASA classification and perioperative variables as predictors of postoperative outcome. Br J Anaesth. 1996 Aug;77(2):217-22.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02841644
• Other Study ID Numbers: 04-15-05E
• First Posted: Jul 22, 2016
• Last Update Posted: Jul 14, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided

Study Results

Participant Flow

Arm/Group Title	Traumatic Arthrotomy- Treated Nonoperatively	Traumatic Arthrotomy- Treated Operatively
Arm/Group Description	Patient diagnosed with traumatic arthrotomy treated nonoperatively. Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy.	Patient diagnosed with traumatic arthrotomy treated operatively. Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy.
Period Title: Overall Study
STARTED	60	120
COMPLETED	60	120
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Traumatic Arthrotomy- Treated Nonoperatively	Traumatic Arthrotomy- Treated Operatively	Total
Arm/Group Description	Patient diagnosed with traumatic arthrotomy treated nonoperatively. Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy.	Patient diagnosed with traumatic arthrotomy treated operatively. Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy.	Total of all reporting groups
Overall Participants	60	120	180
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	31	28.6	30.5
Sex: Female, Male (Count of Participants)
Female	17 28.3%	34 28.3%	51 28.3%
Male	43 71.7%	86 71.7%	129 71.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Cost of Treatments
Description	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. To estimate cost associated with TAs, total charge data was acquired for all patients treated at the lead site.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

We were unable to obtain total charges from half of our our patient population.

Arm/Group Title	Traumatic Arthrotomy- Treated Nonoperatively	Traumatic Arthrotomy- Treated Operatively
Arm/Group Description	Patient diagnosed with traumatic arthrotomy treated nonoperatively. Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy.	Patient diagnosed with traumatic arthrotomy treated operatively. Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy.
Measure Participants	23	67
Median (Full Range) [USD]	1089	11,973

2. Primary Outcome

Title	Complications
Description	Complications were defined as septic arthritis, return to the OR, rehospitalization, and osteomyelitis of the injured joint.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Traumatic Arthrotomy- Treated Nonoperatively	Traumatic Arthrotomy- Treated Operatively
Arm/Group Description	Patient diagnosed with traumatic arthrotomy treated nonoperatively. Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy.	Patient diagnosed with traumatic arthrotomy treated operatively. Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy.
Measure Participants	60	120
Count of Participants [Participants]	4 6.7%	18 15%

3. Secondary Outcome

Title	Comparing 3-Month Change in Veterans RAND 12-Item Health Survey (VR-12) by Treatment Method
Description	The veteran rand 12-tem health survey is used to determine change in health related quality of life to estimate disease burden. It is summarized into two scores, a physical component scores (PCS) (range 0-100) and mental component scores (range- 0-100). Higher score indicate better outcomes.
Time Frame	baseline, 3 months

Outcome Measure Data

Analysis Population Description

Missing VR-12 from 69 patients.

Arm/Group Title	Traumatic Arthrotomy- Treated Nonoperatively	Traumatic Arthrotomy- Treated Operatively
Arm/Group Description	Patient diagnosed with traumatic arthrotomy treated nonoperatively. Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy.	Patient diagnosed with traumatic arthrotomy treated operatively. Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy.
Measure Participants	28	83
VR-12 Physical Health: Baseline	49 (6.9)	48.1 (10.6)
VR-12 Mental Health: Baseline	50.7 (11.2)	51.8 (10.9)
VR-12 Physical Health: 3 month	36.9 (11.4)	32.1 (12.3)
VR-12 Mental Health: 3 Month	41.9 (7.4)	46.8 (8.9)
VR-12 Physical Health: Difference	-12.2 (12.7)	-16.0 (15.3)
VR-12 Mental Health: Difference	-8.8 (10.5)	-5.1 (12.3)

Adverse Events

Time Frame	1 year
Arm/Group Title	Traumatic Arthrotomy- Treated Nonoperatively		Traumatic Arthrotomy- Treated Operatively
Arm/Group Description	Patient diagnosed with traumatic arthrotomy treated nonoperatively. Non-operatively treated traumatic arthrotomy: non-operatively treated traumatic arthrotomy.		Patient diagnosed with traumatic arthrotomy treated operatively. Operatively treated traumatic arthrotomy: operatively treated traumatic arthrotomy.
All Cause Mortality
	Traumatic Arthrotomy- Treated Nonoperatively		Traumatic Arthrotomy- Treated Operatively
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/120 (0%)
Serious Adverse Events
	Traumatic Arthrotomy- Treated Nonoperatively		Traumatic Arthrotomy- Treated Operatively
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/120 (0%)
Other (Not Including Serious) Adverse Events
	Traumatic Arthrotomy- Treated Nonoperatively		Traumatic Arthrotomy- Treated Operatively
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/120 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.