Trials / Active Not Recruiting
Active Not RecruitingNCT03564730
Staged Versus Simultaneous Bilateral Knee Arthroplasty
Randomized Control Trial of Staged Versus Simultaneous Bilateral Total Knee Arthroplasty
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 224 (estimated)
- Sponsor
- Orthopaedic Innovation Centre · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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?"
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Simultaneous Knee Arthroplasty (UKA) | Patient will have both knees completed under one anesthetic. |
| PROCEDURE | Staged Knee Arthroplasty (UKA) | Patient will have knees completed under 2 anesthetics. |
Timeline
- Start date
- 2018-03-19
- Primary completion
- 2026-04-01
- Completion
- 2026-12-01
- First posted
- 2018-06-21
- Last updated
- 2026-02-20
Locations
8 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT03564730. Inclusion in this directory is not an endorsement.