Surgical Management of Knee Septic Arthritis

NCT04786379 | Terminated DMC

• 1 other identifier: IRB #E21085
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Arthritis

Keywords

orthopedic; septic arthritis; synovectomy

Outcome Measures

Primary Outcomes (2)

• Number of surgeries to obtain lasting clinical resolution

  The total number of surgeries performed during initial admission in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics.

  Through time period of initial admission (days; expected under 14 days)

• Hospital length of stay

  The total number of days in which the patient is initially admitted in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics.

  Through time period of initial admission (days; expected under 14 days)

Secondary Outcomes (3)

• Post Operative Pain Scores

  Through time period of initial admission (days; expected under 14 days)

• Post Operative Opioid Use

  Through time period of initial admission (days; expected under 14 days)

• Lysholm Knee Scale

  Through anticipated follow up period of 3 month post operative appointment.

Study Arms (1)

Patients with confirmed septic arthritis of the native knee

EXPERIMENTAL

Procedure: Arthroscopic Irrigation and Debridement; Procedure: Open Arthrotomy with irrigation and debridement

Interventions

Arthroscopic Irrigation and Debridement PROCEDURE

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

Patients with confirmed septic arthritis of the native knee

Open Arthrotomy with irrigation and debridement PROCEDURE

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

Patients with confirmed septic arthritis of the native knee

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

University Medical Center of El Paso

El Paso, Texas, 79905, United States

Location

Related Publications (4)

• 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.

  PMID: 25834080 BACKGROUND

• 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.

  PMID: 26017744 BACKGROUND

• 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.

  PMID: 11561499 BACKGROUND

• 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.

  PMID: 25623272 BACKGROUND

MeSH Terms

Conditions

Arthritis, Infectious

Interventions

Debridement; Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Adam Adler, MD

  Texas Tech University Health Sciences Center of El Paso

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients who are diagnosed with septic arthritis of the native knee will be randomized to either arthroscopic or open treatment.

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 8, 2021
• Study Start: April 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

US (1)