Surgical Management of Knee Septic Arthritis

Sponsor
Texas Tech University Health Sciences Center, El Paso (Other)
Overall Status
Recruiting
CT.gov ID
NCT04786379
Collaborator
(none)
50
1
1
39
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Arthroscopic Irrigation and Debridement
  • Procedure: Open Arthrotomy with irrigation and debridement
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patients who are diagnosed with septic arthritis of the native knee will be randomized to either arthroscopic or open treatment.Patients who are diagnosed with septic arthritis of the native knee will be randomized to either arthroscopic or open treatment.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open vs Arthroscopic Treatment of Septic Arthritis in the Adult Native Knee: A Prospective Trial
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Center of El Paso El Paso Texas United States 79905

Sponsors and Collaborators

  • Texas Tech University Health Sciences Center, El Paso

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Matthew Wells, Principal Investigator, Texas Tech University Health Sciences Center, El Paso
ClinicalTrials.gov Identifier:
NCT04786379
Other Study ID Numbers:
  • IRB #E21085
First Posted:
Mar 8, 2021
Last Update Posted:
Jun 11, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Matthew Wells, Principal Investigator, Texas Tech University Health Sciences Center, El Paso
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 11, 2021