## Protocol Section
### Identification Module
**NCT ID:** NCT06433700

**Brief Title:** Risk of Revision Following Knee Arthroplasty in Bariatric Surgery Patients

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

#### Organization Study ID Info
**ID:** p-2023-14433
#### Organization
**Class:** OTHER
**Full Name:** Bispebjerg Hospital
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-07
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Bispebjerg Hospital

#### Responsible Party

**Investigator Affiliation:** Bispebjerg Hospital

**Investigator Full Name:** Saber Muthanna Saber

**Investigator Title:** Principal Investigator, PhD Fellow

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Arthritis Knee

- Bariatric Surgery Candidate

- Prosthesis Failure

- Prosthesis Survival

- Prosthesis-Related Infections

**Keywords:**

- arthroplasty

- revision

- bariatric

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 90000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 2 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients who received bariatric surgery prior to their knee arthroplasty

**Intervention Names:**

- Other: BAS

**Label:** BAS group

#### Arm Group 2

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

**Intervention Names:**

- Other: Non-BAS

**Label:** Non-BAS group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BAS group

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

**Name:** BAS

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Non-BAS group

**Description:** Patients without BAS codes

**Name:** Non-BAS

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Revision surgery is defined as surgery with debridement and/or exchange of at least one component

**Measure:** Hazard rate of Revision due to any cause

**Time Frame:** within 90 days and within 2 years

**Description:** 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.

**Measure:** Hazard rate of Revision due to infection

**Time Frame:** within 90 days and within 2 years

#### Secondary Outcomes

**Description:** the use of one of the following oral antibiotics: dicloxacillin, flucloxacillin, phenoxymethylpenicillin, amoxicillin, oral ciprofloxacin, roxithromycin, linezolid, cefuroxime and cefalexin

**Measure:** Hazard rate of Knee related antibiotic use within 30- and 90-days following KA

**Time Frame:** within 30- and 90-days following KA

**Description:** the use of one of oral antibiotics other than those that were mentioned in outcome 3.

**Measure:** Hazard rate of Antibiotic use due to other causes

**Time Frame:** within 30- and 90-days following KA

**Description:** Mortality registered in the Danish Civil Registration System (DCRS) by date

**Measure:** Mortality

**Time Frame:** 2 years postoperatively

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Primary knee arthroplasty due to osteoarthritis

Exclusion Criteria:

* Primary knee arthroplasty due to traumatic osteoarthritis.

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ssab0009@regionh.dk

**Name:** Saber M. Saber, MD

**Phone:** 004521299265

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Department of orthopedic surgery, Bispebjerg University Hospital, Denmark

**Name:** Søren Overgaard, MD,DMSc,Prof

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-05-27

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 236674

- Type Abbrev: Prot_SAP

- Upload Date: 2024-05-27T06:03

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007239

- Term: Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M18866

- Name: Prosthesis-Related Infections

- Relevance: HIGH

- As Found: Prosthesis-Related Infections

- ID: M14338

- Name: Prosthesis Failure

- Relevance: HIGH

- As Found: Prosthesis Failure

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016459

- Term: Prosthesis-Related Infections

- ID: D000011475

- Term: Prosthesis Failure

### Misc Info Module

- Version Holder: 2024-05-31
