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NCT Number: NCT06433700

Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients

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.

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Key information

Conditions

Arthritis Knee Bariatric Surgery Candidate Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Prosthesis Survival Prosthesis-Related Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopaedic department, Bispebjerg Hospital

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary knee arthroplasty due to osteoarthritis

Exclusion criteria

  • Primary knee arthroplasty due to traumatic osteoarthritis.

Treatment and study plan

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]).

Non-BAS

Other

Patients without BAS codes

Primary outcomes

  1. Hazard rate of Revision due to any cause

    Time frame: within 90 days and within 2 years

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

  2. Hazard rate of Revision due to infection

    Time frame: 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 outcomes

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

    Time frame: 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

  2. Hazard rate of Antibiotic use due to other causes

    Time frame: within 30- and 90-days following KA

    the use of one of oral antibiotics other than those that were mentioned in outcome 3.

  3. Mortality

    Time frame: 2 years postoperatively

    Mortality registered in the Danish Civil Registration System (DCRS) by date

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

Risk of Revision and Other Complications Following Knee Arthroplasty in Patients Previously Exposed to Bariatric Surgeries: A Nationwide, Register-based Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 30, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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