Clinical trial NCT04786379: Surgical Management of Knee Septic Arthritis
Official title: Open vs Arthroscopic Treatment of Septic Arthritis in the Adult Native Knee: A Prospective Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Septic Arthritis
Keywords: orthopedic
septic arthritis
synovectomy
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients who are diagnosed with septic arthritis of the native knee will be randomized to either arthroscopic or open treatment.
Primary purpose: TREATMENT

Brief summary: Surgical excisional debridement is the mainstay of management in septic arthritis with necessary decompression, lavage, debridement, and partial synovectomy. However, there has been considerable debate over the optimal modality. Most surgeons perform an open arthrotomy or arthroscopic debridement, although serial aspiration can be considered as an option in very limited circumstances with patients who cannot tolerate surgery. While open arthrotomy has been often utilized, there has been an increasing number of proponents for arthroscopic treatment citing lower re-infection rates and better functional outcomes. However, there has been a lack of well-designed prospective studies comparing surgical treatment modalities for native knee septic arthritis. The goals of this present study are to determine if arthroscopic management of septic arthritis in the native knee resulted in a lower number of surgeries and a shorter length of stay compared to open arthrotomy. Secondary outcomes included differences in postoperative pain and improvements in Lysholm knee scores.


Eligibility criteria: Inclusion Criteria:

* Adults (\>18 years old)
* Have a diagnosis of septic arthritis of the native knee (synovial WBC \>50k or acrystalline elevated synovial WBC \>25,000 with high clinical suspicion)
* Willingness to participate in the study

Exclusion Criteria:

* Unwilling to participate in the study
* Acrystalline elevated synovial WBC \< 25,000
* Crystalline arthropathy with elevated synovial WBC but \< 50,000
* Have a history of a prior knee prosthesis (hemiarthroplasty, total knee arthroplasty)

Primary outcomes:
measure: Number of surgeries to obtain lasting clinical resolution
timeFrame: Through time period of initial admission (days; expected under 14 days)
measure: Hospital length of stay
timeFrame: Through time period of initial admission (days; expected under 14 days)
Secondary outcomes:
measure: Post Operative Pain Scores
timeFrame: Through time period of initial admission (days; expected under 14 days)
measure: Post Operative Opioid Use
timeFrame: Through time period of initial admission (days; expected under 14 days)
measure: Lysholm Knee Scale
timeFrame: Through anticipated follow up period of 3 month post operative appointment.
Other outcomes:
Locations:
city: El Paso
country: United States
facility: University Medical Center of El Paso
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center of El Paso
name: Adam Adler, MD
role: STUDY_DIRECTOR
References:
citation: Hunter JG, Gross JM, Dahl JD, Amsdell SL, Gorczyca JT. Risk factors for failure of a single surgical debridement in adults with acute septic arthritis. J Bone Joint Surg Am. 2015 Apr 1;97(7):558-64. doi: 10.2106/JBJS.N.00593.
citation: Bohler C, Dragana M, Puchner S, Windhager R, Holinka J. Treatment of septic arthritis of the knee: a comparison between arthroscopy and arthrotomy. Knee Surg Sports Traumatol Arthrosc. 2016 Oct;24(10):3147-3154. doi: 10.1007/s00167-015-3659-8. Epub 2015 May 28.
citation: Wirtz DC, Marth M, Miltner O, Schneider U, Zilkens KW. Septic arthritis of the knee in adults: treatment by arthroscopy or arthrotomy. Int Orthop. 2001;25(4):239-41. doi: 10.1007/s002640100226.
citation: Aim F, Delambre J, Bauer T, Hardy P. Efficacy of arthroscopic treatment for resolving infection in septic arthritis of native joints. Orthop Traumatol Surg Res. 2015 Feb;101(1):61-4. doi: 10.1016/j.otsr.2014.11.010. Epub 2015 Jan 23.