Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433700
• Other study ID #: p-2023-14433
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Bispebjerg Hospital
• Contact: Saber M. Saber, MD
• Phone: 004521299265
• Email: ssab0009[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90000
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary knee arthroplasty due to osteoarthritis

Exclusion Criteria:

• Primary knee arthroplasty due to traumatic osteoarthritis.

Related Conditions & MeSH terms

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

Intervention

Other:
• BAS
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
Patients without BAS codes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	within 30- and 90-days following KA
Secondary	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.	within 30- and 90-days following KA
Secondary	Mortality	Mortality registered in the Danish Civil Registration System (DCRS) by date	2 years postoperatively