Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients

NCT06433700 | Completed

• 1 other identifier: p-2023-14433
• Study Type: observational
• Target: 99,965
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthesis Survival; Prosthesis-Related Infections; Arthritis Knee; Bariatric Surgery Candidate; Prosthesis Failure

Keywords

arthroplasty; revision; bariatric

Outcome Measures

Primary Outcomes (2)

• Hazard rate of Revision due to any cause

  Revision surgery is defined as surgery with debridement and/or exchange of at least one component

  within 90 days and within 2 years

• Hazard rate of Revision due to infection

  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.

  within 90 days and within 2 years

Secondary Outcomes (3)

• Hazard rate of Knee related antibiotic use within 30- and 90-days following KA

  within 30- and 90-days following KA

• Hazard rate of Antibiotic use due to other causes

  within 30- and 90-days following KA

• Mortality

  2 years postoperatively

Study Arms (2)

BAS group

Patients who received bariatric surgery prior to their knee arthroplasty

Other: BAS

Non-BAS group

Patients who did not receive bariatric surgery prior to their knee arthroplasty

Other: Non-BAS

Interventions

BAS OTHER

NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures (KJDF10 \& KJDF11 \[gastric bypass\]; KJDF20 \& KJDF21 \[gastric banding\]; KJDF40, KJDF41, KJDF96 \& KJDF97 \[gastric sleeve\]).

BAS group

Non-BAS OTHER

Patients without BAS codes

Non-BAS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators will include patients with primary/idiopathic or secondary (due to meniscus or cruciate ligament lesion) osteoarthritis (OA) who received primary KA in the period from 2011 and 2 years earlier to data-extraction date. Patients will be identified from the DKR. Patients are followed for 2 years, until first revision, death or migration, whichever comes first.

You may qualify if:

• Primary knee arthroplasty due to osteoarthritis

You may not qualify if:

• Primary knee arthroplasty due to traumatic osteoarthritis.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Orthopaedic department, Bispebjerg Hospital

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Prosthesis Failure; Prosthesis-Related Infections

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Søren Overgaard, MD,DMSc,Prof

  Department of orthopedic surgery, Bispebjerg University Hospital, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Fellow

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: May 30, 2024
• Study Start: June 1, 2024
• Primary Completion: December 2, 2024
• Study Completion: February 1, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)