Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients

Active, not recruiting

• Conditions: Prosthesis Failure; Prosthesis Survival; Bariatric Surgery Candidate; Prosthesis-Related Infections; Arthritis Knee
• Interventions: Other: BAS; Other: Non-BAS

• Registration Number: NCT06433700
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Previous studies have investigated the outcomes of Knee Arthroplasty (KA) following Bariatric Surgery (BAS), but with substantial limitations as not stratifying for Body Mass Index (BMI) at time of KA or not addressing the type of BAS (gastric bypass, banding or sleeve). Since BMI varies greatly in patients with previous BAS, it is likely that BMI affects outcomes after KA in BAS-operated patients.

The investigators believe that stratifying for BMI would explain the contradictions with the previous research in this patient group when it comes to the risk of revision after KA.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-07
• Study First Submitted QC: 2024-05-27
• Study First Posted: 2024-05-30
• Study Start: 2024-06-01
• Status Verified: 2024-12
• Primary Completion: 2024-12-02
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90000

Inclusion Criteria

• Primary knee arthroplasty due to osteoarthritis

Exclusion Criteria

• Primary knee arthroplasty due to traumatic osteoarthritis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAS group	BAS	Patients who received bariatric surgery prior to their knee arthroplasty
Non-BAS group	Non-BAS	Patients who did not receive bariatric surgery prior to their knee arthroplasty

Primary Outcome Measures

Name	Time	Method
Hazard rate of Revision due to any cause	within 90 days and within 2 years	Revision surgery is defined as surgery with debridement and/or exchange of at least one component
Hazard rate of Revision due to infection	within 90 days and within 2 years	Our definition of infection is adapted from the European Bone and Joint Infection Society (EBJIS) criteria as at least one of the following A. An indication of deep infection is reported to the Danish knee arthroplasty register (DKR) by the surgeon on revision surgery B. At least 2 deep-tissue samples of phenotypically indistinguishable bacteria isolated from at least 3 deep-tissue samples C. One or more positive intraoperative samples from a closed fluid aspirate AND a biopsy (fluid AND tissue) of phenotypically indistinguishable bacteria isolated.

Secondary Outcome Measures

Name	Time	Method
Mortality	2 years postoperatively	Mortality registered in the Danish Civil Registration System (DCRS) by date
Hazard rate of Knee related antibiotic use within 30- and 90-days following KA	within 30- and 90-days following KA	the use of one of the following oral antibiotics: dicloxacillin, flucloxacillin, phenoxymethylpenicillin, amoxicillin, oral ciprofloxacin, roxithromycin, linezolid, cefuroxime and cefalexin
Hazard rate of Antibiotic use due to other causes	within 30- and 90-days following KA	the use of one of oral antibiotics other than those that were mentioned in outcome 3.

Trial Locations

Locations (1)

Orthopaedic department, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark