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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

413 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-08

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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

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Infection Joint Joint Infection Arthroplasty Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Two surgeon bilateral TKA group

2 surgeons will perform simultaneous total knee arthroplasty in this group.

Group Type EXPERIMENTAL

Simultaneous bilateral total knee arthroplasty

Intervention Type PROCEDURE

Two surgeon bilateral TKA group

Single surgeon bilateral TKA group

One surgeon will perform sequentially tptal knee arthroplasty in this group

Group Type ACTIVE_COMPARATOR

Sequenced bilateral TKA

Intervention Type PROCEDURE

Single surgeon bilateral TKA group

Interventions

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Simultaneous bilateral total knee arthroplasty

Two surgeon bilateral TKA group

Intervention Type PROCEDURE

Sequenced bilateral TKA

Single surgeon bilateral TKA group

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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