Staged Versus Simultaneous Bilateral Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Randomized Control Trial of Staged Versus Simultaneous Bilateral Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03564730
• Other study ID #: B2017-046
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: December 2026

Study information

• Verified date: June 2023
• Source: Orthopaedic Innovation Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?"

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 224
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Simultaneous Knee Arthroplasty (UKA)
Patient will have both knees completed under one anesthetic.
• Staged Knee Arthroplasty (UKA)
Patient will have knees completed under 2 anesthetics.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	St. Joseph's - McMaster University	Hamilton	Ontario
Canada	Kingston Health Sciences Center - KGH	Kingston	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	McGill University	Montréal	Quebec
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Concordia Hospital	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Orthopaedic Innovation Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Veterans Rand 12-item Health Survey Score (VR-12)	The VR-12 is a 12-item questionnaire corresponding to eight principal physical and mental health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health; patient-reported.	1 Year
Secondary	Joint function (Oxford-12 knee score)	The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option (0-4). A total of the 12 items will indicated the joint function; lower total score = poorer function.	Pre-operative, 6 months, 12 months, 18 months, 24 months
Secondary	Return to work	Assessment of ability to return to work and time away from work following surgery.	Pre-operative, 6 months, 12 months, 18 months, 24 months
Secondary	Patient satisfaction	Evaluate change in patient-reported satisfaction using a Likaert scale; 1=Very Satisfied to 5=Very Unsatisfied.	6 months, 12 months, 18 months, 24 months
Secondary	Complications	Evaluation type and frequency of complication (adverse events).	Intraoperative, 6 months, 12 months, 18 months, 24 months
Secondary	Hospital stay	Number of days in hospital	Up to 1 week
Secondary	Transfusion rate	Number of unit transfused during hospital stay.	Up to 1 week
Secondary	Costs of knee replacement surgery	An attempt to calculate costs of surgery using length of stay data to calculate cost between Simultaneous vs Staged procedures. Length of stay will be calculated in days/hours.	Up to 1 week