Staged Versus Simultaneous Bilateral Knee Arthroplasty

Orthopaedic Innovation Centre

Status: Active, not recruiting

Conditions: Knee Osteoarthritis

Treatments: Procedure: Simultaneous Knee Arthroplasty (UKA); Procedure: Staged Knee Arthroplasty (UKA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03564730

B2017-046

Details and patient eligibility

About

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?"

Full description

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.

Enrollment: 224 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

Total Knee Arthroplasty (TKA)

Active Comparator group

Description:

Patient will have complete replacement - Simultaneous vs Staged

Treatment:

Procedure: Staged Knee Arthroplasty (UKA)

Procedure: Simultaneous Knee Arthroplasty (UKA)

Unicompartmental Knee Arthroplasty (UKA)

Active Comparator group

Description:

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

Treatment:

Procedure: Staged Knee Arthroplasty (UKA)

Procedure: Simultaneous Knee Arthroplasty (UKA)