Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients

NCT ID: NCT06433700

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

90000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BAS group

Patients who received bariatric surgery prior to their knee arthroplasty

BAS

Intervention Type 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 group

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

Non-BAS

Intervention Type OTHER

Patients without BAS codes

Interventions

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BAS

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

Intervention Type OTHER

Non-BAS

Patients without BAS codes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Primary knee arthroplasty due to osteoarthritis

Exclusion Criteria

* Primary knee arthroplasty due to traumatic osteoarthritis.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Saber Muthanna Saber

Principal Investigator, PhD Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Søren Overgaard, MD,DMSc,Prof

Role: STUDY_DIRECTOR

Department of orthopedic surgery, Bispebjerg University Hospital, Denmark

Locations

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Orthopaedic department, Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: SAP outlined

View Document

Document Type: Statistical Analysis Plan: Detailed SAP

View Document

Other Identifiers

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p-2023-14433

Identifier Type: -

Identifier Source: org_study_id