Staged Versus Simultaneous Bilateral Knee Arthroplasty

Randomized Control Trial of Staged Versus Simultaneous Bilateral Total Knee Arthroplasty

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?"

Study Overview

• Status: Active, not recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Simultaneous Knee Arthroplasty (UKA); Procedure: Staged Knee Arthroplasty (UKA)

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.

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trevor Gascoyne; Phone Number: 204-926-1235; Email: tgascoyne@orthoinno.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2P 3C5
      • University of Calgary
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 3S8
      • Concordia Hospital
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's - McMaster University
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Center - KGH
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
  • Quebec
    • Montréal, Quebec, Canada, H3A 0G4
      • McGill University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Total Knee Arthroplasty (TKA); Patient will have complete replacement - Simultaneous vs Staged	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.
Active Comparator: Unicompartmental Knee Arthroplasty (UKA); Patient will have half-knee replacement (partial) - Simultaneous vs Staged	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Complications	Evaluation type and frequency of complication (adverse events).	Intraoperative, 6 months, 12 months, 18 months, 24 months
Hospital stay	Number of days in hospital	Up to 1 week
Transfusion rate	Number of unit transfused during hospital stay.	Up to 1 week
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

Collaborators and Investigators

• Sponsor: Orthopaedic Innovation Centre
• Investigators: Principal Investigator: Eric R. Bohm, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Bilateral, staged, simultaneous
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: B2017-046

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No