N/A
N=180
Operative and Non-operative Treatment of Traumatic Arthrotomies
Traumatic Arthrotomy
Bottom Line
View on ClinicalTrials.gov: NCT02841644 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Cost of Treatments — 1089; 11,973 USD
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Operatively treated traumatic arthrotomy (Procedure); Non-operatively treated traumatic arthrotomy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cost of Treatments |
1089; 11,973 | — |
| PRIMARY Complications |
4; 18 | — |
| SECONDARY Comparing 3-Month Change in Veterans RAND 12-Item Health Survey (VR-12) by Treatment Method |
49; 48.1; 50.7; 51.8; 36.9; 32.1 | — |
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.
Eligibility Criteria
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.
a. 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
Data sourced from ClinicalTrials.gov (NCT02841644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.