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Surgical Management of Knee Septic Arthritis

NCT ID: NCT04786379

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Septic Arthritis

Keywords

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orthopedic septic arthritis synovectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients who are diagnosed with septic arthritis of the native knee will be randomized to either arthroscopic or open treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with confirmed septic arthritis of the native knee

Group Type EXPERIMENTAL

Arthroscopic Irrigation and Debridement

Intervention Type PROCEDURE

Patients with confirmed septic arthritis treated with multiple small incisions to perform irrigation and debridement with partial synovectomy.

Open Arthrotomy with irrigation and debridement

Intervention Type PROCEDURE

Patients with confirmed septic arthritis treated with a single large incision, open arthrotomy to perform irrigation and debridement with partial synovectomy.

Interventions

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Arthroscopic Irrigation and Debridement

Patients with confirmed septic arthritis treated with multiple small incisions to perform irrigation and debridement with partial synovectomy.

Intervention Type PROCEDURE

Open Arthrotomy with irrigation and debridement

Patients with confirmed septic arthritis treated with a single large incision, open arthrotomy to perform irrigation and debridement with partial synovectomy.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Tech University Health Sciences Center, El Paso

OTHER

Sponsor Role lead

Responsible Party

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Matthew Wells

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Adler, MD

Role: STUDY_DIRECTOR

Texas Tech University Health Sciences Center of El Paso

Locations

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University Medical Center of El Paso

El Paso, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25834080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26017744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11561499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25623272 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB #E21085

Identifier Type: -

Identifier Source: org_study_id