Surgical Management of Knee Septic Arthritis

Septic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04786379
• Other study ID #: IRB #E21085
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: December 2023
• Source: Texas Tech University Health Sciences Center, El Paso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Infectious
• Septic Arthritis

Intervention

Procedure:
• Arthroscopic Irrigation and Debridement
Patients with confirmed septic arthritis treated with multiple small incisions to perform irrigation and debridement with partial synovectomy.
• 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.

Locations

Country	Name	City	State
United States	University Medical Center of El Paso	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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	Through time period of initial admission (days; expected under 14 days)
Secondary	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.	Through time period of initial admission (days; expected under 14 days)
Secondary	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.	Through anticipated follow up period of 3 month post operative appointment.