Surgical Management of Knee Septic Arthritis

December 1, 2023 updated by: Matthew Wells, Texas Tech University Health Sciences Center, El Paso

Open vs Arthroscopic Treatment of Septic Arthritis in the Adult Native Knee: A Prospective Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • El Paso, Texas, United States, 79905
        • University Medical Center of El Paso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with confirmed septic arthritis of the native knee
Procedure: Arthroscopic Irrigation and Debridement
Patients with confirmed septic arthritis treated with multiple small incisions to perform irrigation and debridement with partial synovectomy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of surgeries to obtain lasting clinical resolution
Time Frame: 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.
Through time period of initial admission (days; expected under 14 days)
Hospital length of stay
Time Frame: 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.
Through time period of initial admission (days; expected under 14 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Pain Scores
Time Frame: 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
Through time period of initial admission (days; expected under 14 days)
Post Operative Opioid Use
Time Frame: 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.
Through time period of initial admission (days; expected under 14 days)
Lysholm Knee Scale
Time Frame: 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.
Through anticipated follow up period of 3 month post operative appointment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University Health Sciences Center, El Paso

Investigators

  • Study Director: Adam Adler, MD, Texas Tech University Health Sciences Center of El Paso

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #E21085

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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