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CompletedNCT06433700Updated Feb 27, 2026

Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients

An observational study in Arthritis Knee, Bariatric Surgery Candidate and Prosthesis Failure, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Bispebjerg Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
99,965
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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

Keywords

  • arthroplasty
  • revision
  • bariatric
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In context

Prosthesis Failure

119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.

This study's enrollment of 99,965 is above the median of 119 across 49 observational studies indexed under Prosthesis Failure.

Browse Prosthesis Failure studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary knee arthroplasty due to osteoarthritis

Exclusion criteria

Exclusion Criteria:

  • Primary knee arthroplasty due to traumatic osteoarthritis.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
99,965 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherBAS

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

  • OtherNon-BAS

    Patients without BAS codes

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What researchers measure

Primary outcomes

  1. Hazard rate of Revision due to any cause

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

    Time frame: within 90 days and within 2 years

  2. 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.

    Time frame: within 90 days and within 2 years

Secondary outcomes

  1. Hazard rate of Knee related antibiotic use 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

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

  2. Hazard rate of Antibiotic use due to other causes

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

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

  3. Mortality

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

    Time frame: 2 years postoperatively

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Study locations

1 site
  • Orthopaedic department, Bispebjerg Hospital
    Copenhagen, Denmark
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06433700
Responsible party
Saber Muthanna Saber (Principal Investigator, PhD Fellow, Bispebjerg Hospital) — Principal investigator
First posted
May 30, 2024
Start date
Jun 1, 2024
Primary completion
Dec 2, 2024
Completion
Feb 1, 2025
Last update
Feb 27, 2026

Study contacts

Søren Overgaard, MD,DMSc,Prof
study director · Department of orthopedic surgery, Bispebjerg University Hospital, Denmark

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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