NCT04413565

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 413 (estimated)
• Sponsor: Bezmialem Vakif University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection Joint
• Joint Infection
• Arthroplasty Complications

Interventions

Type	Name	Description
PROCEDURE	Simultaneous bilateral total knee arthroplasty	Two surgeon bilateral TKA group
PROCEDURE	Sequenced bilateral TKA	Single surgeon bilateral TKA group

Timeline

• Start date: 2016-12-08
• Primary completion: 2020-11-30
• Completion: 2020-12-31
• First posted: 2020-06-04
• Last updated: 2020-06-04

Locations

1 site across 1 country: Turkey (Türkiye)