Surgical Management of Knee Septic Arthritis

Not Applicable

Terminated

• Conditions: Septic Arthritis
• Interventions: Procedure: Arthroscopic Irrigation and Debridement; Procedure: Open Arthrotomy with irrigation and debridement

• Registration Number: NCT04786379
• Lead Sponsor: Texas Tech University Health Sciences Center, El Paso

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-08
• Study Start: 2021-04-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with confirmed septic arthritis of the native knee	Arthroscopic Irrigation and Debridement	-
Patients with confirmed septic arthritis of the native knee	Open Arthrotomy with irrigation and debridement	-

Primary Outcome Measures

Name	Time	Method
Number of surgeries to obtain lasting clinical resolution	Through time period of initial admission (days; expected under 14 days)	The total number of surgeries performed during initial admission in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics.
Hospital length of stay	Through time period of initial admission (days; expected under 14 days)	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.

Secondary Outcome Measures

Name	Time	Method
Post Operative Pain Scores	Through time period of initial admission (days; expected under 14 days)	Daily morning and afternoon visual analogue scale reported by nursing staff. This value is reported on a scale of 0-10; a score of 0 indicates no pain while 10 indicates unbearable pain
Lysholm Knee Scale	Through anticipated follow up period of 3 month post operative appointment.	The Lysholm score is a 100-point scoring system for examining a patient's knee-specific symptoms including mechanical locking, instability, pain, swelling, stair climbing, and squatting. The scoring is between 0-100 points. A score of \<65 indicates poor knee function, 65-83 indicates fair knee function, 84-94 indicates a fair outcome, and 95-100 indicates excellent knee function. This scoring system will be obtained at 2 week, 6 week, and 3 months.
Post Operative Opioid Use	Through time period of initial admission (days; expected under 14 days)	All patients will have post operative pain medications which are to be utilized in a step wise manner for treating their pain. For example, if they are in minimal pain they will be given tylenol whereas unbearable pain will be treated with opioid analgesics. The average total post-operative opioid usage during initial admission will be reported as total morphine milligram equivalent.

Trial Locations

Locations (1)

University Medical Center of El Paso; 🇺🇸 El Paso, Texas, United States