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Surgical Management of Knee Septic Arthritis

Primary Purpose

Septic Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arthroscopic Irrigation and Debridement
Open Arthrotomy with irrigation and debridement
Sponsored by
Texas Tech University Health Sciences Center, El Paso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Arthritis focused on measuring orthopedic, septic arthritis, synovectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Medical Center of El PasoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with confirmed septic arthritis of the native knee

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Post Operative Pain Scores
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
Post Operative Opioid Use
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.
Lysholm Knee Scale
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.

Full Information

First Posted
February 24, 2021
Last Updated
June 8, 2021
Sponsor
Texas Tech University Health Sciences Center, El Paso
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1. Study Identification

Unique Protocol Identification Number
NCT04786379
Brief Title
Surgical Management of Knee Septic Arthritis
Official Title
Open vs Arthroscopic Treatment of Septic Arthritis in the Adult Native Knee: A Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Tech University Health Sciences Center, El Paso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Arthritis
Keywords
orthopedic, septic arthritis, synovectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients who are diagnosed with septic arthritis of the native knee will be randomized to either arthroscopic or open treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with confirmed septic arthritis of the native knee
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Irrigation and Debridement
Intervention Description
Patients with confirmed septic arthritis treated with multiple small incisions to perform irrigation and debridement with partial synovectomy.
Intervention Type
Procedure
Intervention Name(s)
Open Arthrotomy with irrigation and debridement
Intervention Description
Patients with confirmed septic arthritis treated with a single large incision, open arthrotomy to perform irrigation and debridement with partial synovectomy.
Primary Outcome Measure Information:
Title
Number of surgeries to obtain lasting clinical resolution
Description
The total number of surgeries performed during initial admission in order to obtain appropriate clinical response and resultant discharge on outpatient antibiotics.
Time Frame
Through time period of initial admission (days; expected under 14 days)
Title
Hospital length of stay
Description
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.
Time Frame
Through time period of initial admission (days; expected under 14 days)
Secondary Outcome Measure Information:
Title
Post Operative Pain Scores
Description
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
Time Frame
Through time period of initial admission (days; expected under 14 days)
Title
Post Operative Opioid Use
Description
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.
Time Frame
Through time period of initial admission (days; expected under 14 days)
Title
Lysholm Knee Scale
Description
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.
Time Frame
Through anticipated follow up period of 3 month post operative appointment.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew E Wells, DO
Phone
915-215-5400
Email
matthew.wells@ttuhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Adler, MD
Organizational Affiliation
Texas Tech University Health Sciences Center of El Paso
Official's Role
Study Director
Facility Information:
Facility Name
University Medical Center of El Paso
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Wells, DO
Email
matthew.eric.wells@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25834080
Citation
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.
Results Reference
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PubMed Identifier
26017744
Citation
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.
Results Reference
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PubMed Identifier
11561499
Citation
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.
Results Reference
background
PubMed Identifier
25623272
Citation
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.
Results Reference
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Surgical Management of Knee Septic Arthritis

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