Two-stage Arthroplasty for the Septic Arthritis of the Native Knee Joint

NCT05484284 | Completed

• 1 other identifier: 2022-0292
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Septic arthritis (SA) of the native knee joint is rare but difficult to manage. Open or arthroscopic debridement is currently the most widely used approach. The problem is that there is a 71% and 50% chance of requiring revision surgery, respectively. Patients with recurrent sepsis may require arthrodesis or amputation, which would result in severe functional loss. Therefore, there is an urgent need to find more effective surgical procedures. Investigators developed a two-stage exchange with low-dose antibiotics for the treatment of SA and evaluated its efficacy.

Conditions

Septic Arthritis

Outcome Measures

Primary Outcomes (7)

• Surgical success rate

  The clearance rate of infection

  two years postoperatively

• Surgical success rate

  The clearance rate of infection

  three years postoperatively

• Surgical success rate

  The clearance rate of infection

  four years postoperatively

• Surgical success rate

  The clearance rate of infection

  five years postoperatively

• Surgical success rate

  The clearance rate of infection

  six years postoperatively

• Surgical success rate

  The clearance rate of infection

  seven years postoperatively

• Surgical success rate

  The clearance rate of infection

  eight years postoperatively

Secondary Outcomes (1)

• change from baseline in knee joint function

  baseline, 1 month, 2 month, 3 month, 6 month, and yearly postoperatively

Study Arms (1)

All the patients

EXPERIMENTAL

patients received two-stage primary total knee arthroplasty with low-dose antibiotics

Procedure: two-stage primary total knee arthroplasty with low-dose antibiotics

Interventions

two-stage primary total knee arthroplasty with low-dose antibiotics PROCEDURE

Briefly, investigators completely debrided all necrotic soft tissue in the first stage of the operation. The surgical site was flushed twice with hydrogen peroxide, iodine, and saline solutions. Then, the antibiotic-loaded cement spacer was inserted. After surgery, a 10-day course of intravenous organism-specific antibiotics or vancomycin was administered, followed by oral antibiotic therapy. Second-stage reimplantation was performed once there was no sign of infection. The spacer was removed and the new prosthesis was implanted without the use of antibiotic-containing bone cement.

All the patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with SA based on one or more of the following: clinical presentations (fever, joint pain, restricted mobility, swelling and redness, and/or a discharging sinus communicating with the joint); elevated inflammation markers; evidence of infection on images; purulence in the joint, and positive frozen section or cultures
• Without infections at other sites
• Without venous thrombosis of the lower limbs
• American society of Anesthesiologists (ASA) physical status classification was either 1 or 2
• With complete data for the main indicators (routine blood test results, C-reactive protein level, erythrocyte sedimentation rate, X-ray and/or MRI scans of the surgical site, and the Knee Society Function scores).

You may not qualify if:

• Patients (\<60 yrs) without progression to advanced osteoarthritis
• In poor general condition who could not tolerate surgery

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 300001, China

Location

Related Publications (2)

• Ross JJ. Septic Arthritis of Native Joints. Infect Dis Clin North Am. 2017 Jun;31(2):203-218. doi: 10.1016/j.idc.2017.01.001. Epub 2017 Mar 30.

  PMID: 28366221 BACKGROUND

• Mathews CJ, Weston VC, Jones A, Field M, Coakley G. Bacterial septic arthritis in adults. Lancet. 2010 Mar 6;375(9717):846-55. doi: 10.1016/S0140-6736(09)61595-6.

  PMID: 20206778 BACKGROUND

MeSH Terms

Conditions

Arthritis, Infectious

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Lan Tang, MD

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 2, 2022
• Study Start: February 22, 2022
• Primary Completion: April 6, 2022
• Study Completion: April 22, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)