Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAS group | Patients who received bariatric surgery prior to their knee arthroplasty |
| |
| Non-BAS group | Patients who did not receive bariatric surgery prior to their knee arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAS | Other | NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures (KJDF10 & KJDF11 [gastric bypass]; KJDF20 & KJDF21 [gastric banding]; KJDF40, KJDF41, KJDF96 & KJDF97 [gastric sleeve]). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Søren Overgaard, MD,DMSc,Prof | Department of orthopedic surgery, Bispebjerg University Hospital, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic department, Bispebjerg Hospital | Copenhagen | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: SAP outlined | May 27, 2024 | May 27, 2024 | Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Detailed SAP | Nov 26, 2024 | Dec 2, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011475 | Prosthesis Failure |
| D016459 | Prosthesis-Related Infections |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| Non-BAS | Other | Patients without BAS codes |
|
| 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 |
| Mortality | Mortality registered in the Danish Civil Registration System (DCRS) by date | 2 years postoperatively |