Staged Versus Simultaneous Bilateral Knee Arthroplasty

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-19

Study Completion Date

2026-12-31

Brief Summary

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The purpose of this study is to assist surgeons and patients in answering the question "Should I have both knees replaced at the same time, or should I just do one and wait to do the second one?"

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Detailed Description

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This is a multi-center randomized controlled trial of 224 patients in order to clearly delineate differences in post-operative outcomes and the trajectory of recovery between simultaneous and staged bilateral KA. The primary outcome measure is difference in generic health related quality of life between the two groups measured 1 year following surgery. Secondary outcome measures include differences in joint specific scores, time off work, satisfaction and costs.

This trial will inform patients and clinicians about differences in recovery, function and efficacy of the procedure to aid in the selection of treatment pathway to best suit the patient.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized to either simultaneous or staged bilateral KA procedures using randomly generated numbers permuted in blocks of 10.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Total Knee Arthroplasty (TKA)

Patient will have complete replacement - Simultaneous vs Staged

Group Type ACTIVE_COMPARATOR

Simultaneous Knee Arthroplasty (UKA)

Intervention Type PROCEDURE

Patient will have both knees completed under one anesthetic.

Staged Knee Arthroplasty (UKA)

Intervention Type PROCEDURE

Patient will have knees completed under 2 anesthetics.

Unicompartmental Knee Arthroplasty (UKA)

Patient will have half-knee replacement (partial) - Simultaneous vs Staged

Group Type ACTIVE_COMPARATOR

Simultaneous Knee Arthroplasty (UKA)

Intervention Type PROCEDURE

Patient will have both knees completed under one anesthetic.

Staged Knee Arthroplasty (UKA)

Intervention Type PROCEDURE

Patient will have knees completed under 2 anesthetics.

Interventions

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Simultaneous Knee Arthroplasty (UKA)

Patient will have both knees completed under one anesthetic.

Intervention Type PROCEDURE

Staged Knee Arthroplasty (UKA)

Patient will have knees completed under 2 anesthetics.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients considering bilateral knee arthroplasty
* Patients must sign the consent form
* Patients must be willing to complete the study questionnaires for the duration of the study

Exclusion Criteria

* Patients who require simultaneous bilateral knee replacement surgery in order to manage significant bilateral flexion or valgus knee contractures where staged procedures may result in suboptimal outcomes by increasing the risk of post-operative flexion contracture in the "first replaced" knee
* patients who are unable to complete the questionnaires

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes