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Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06433700
Enrollment
99965
Registered
2024-05-30
Start date
2024-06-01
Completion date
2025-02-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

arthroplasty, revision, bariatric

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.

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

Sponsors

Bispebjerg Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primary knee arthroplasty due to osteoarthritis

Exclusion criteria

* Primary knee arthroplasty due to traumatic osteoarthritis.

Design outcomes

Primary

MeasureTime frameDescription
Hazard rate of Revision due to any causewithin 90 days and within 2 yearsRevision surgery is defined as surgery with debridement and/or exchange of at least one component
Hazard rate of Revision due to infectionwithin 90 days and within 2 yearsOur 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

MeasureTime frameDescription
Hazard rate of Knee related antibiotic use within 30- and 90-days following KAwithin 30- and 90-days following KAthe 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 causeswithin 30- and 90-days following KAthe use of one of oral antibiotics other than those that were mentioned in outcome 3.
Mortality2 years postoperativelyMortality registered in the Danish Civil Registration System (DCRS) by date

Countries

Denmark

Contacts

STUDY_DIRECTORSøren Overgaard, MD,DMSc,Prof

Department of orthopedic surgery, Bispebjerg University Hospital, Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026