Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study

Not Applicable

• Conditions: Arthroplasty Complications; Infection Joint; Joint Infection
• Interventions: Procedure: Sequenced bilateral TKA; Procedure: Simultaneous bilateral total knee arthroplasty

• Registration Number: NCT04413565
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

The use of bilateral total knee replacements (TKR) is increasing with the number of patients with bilateral end-stage knee osteoarthritis. Bilateral TKR can be performed in three different ways: single-stage, two-team simultaneous bilateral TKR (two surgeons bilateral TKR); single-stage, a sequential bilateral TKR (single surgeon bilateral TKR); and two-stage bilateral TKR. Periprosthetic joint (PJI) infections are serious complications after TKR that negatively affect the aimed outcome, decrease patient satisfaction, and increase morbidity and mortality. The incidence of PJI is 1-2% and the number of cases is projected to grow as the indications for TKR continue to increase. Investigators will prospectively compare the incidence of periprosthetic joint infection between groups.

Detailed Description

924 knees (462 participants) will prospectively be randomized into 2 groups: two surgeons bilateral TKA and single surgeon bilateral TKA. While 2 surgeons will perform simultaneous total knee arthroplasty in the two surgeons' bilateral TKA group, one surgeon will perform sequentially in the single surgeon bilateral TKA group. The primary outcome is to compare the incidence of PJI between the groups. Secondary, logistic regression use to estimate the effect of two surgeons bilateral TKA and single surgeon bilateral TKA on the likelihood of a patient being infected.

Study Timeline

• Study Start: 2016-12-08
• Status Verified: 2020-05
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-05-29
• Last Update Submitted: 2020-05-29
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 413

Inclusion Criteria

Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization

Exclusion Criteria

no history of malignancy without severe extra-articular deformities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single surgeon bilateral TKA group	Sequenced bilateral TKA	One surgeon will perform sequentially tptal knee arthroplasty in this group
Two surgeon bilateral TKA group	Simultaneous bilateral total knee arthroplasty	2 surgeons will perform simultaneous total knee arthroplasty in this group.

Primary Outcome Measures

Name	Time	Method
Infection incedence	90 days	Early infection rates

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey