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
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Bispebjerg Hospital |
Type | Measure | Description | Time frame | Safety issue |
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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 |
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