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Staged Versus Simultaneous Bilateral Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Simultaneous Knee Arthroplasty (UKA)
Staged Knee Arthroplasty (UKA)
Sponsored by
Orthopaedic Innovation Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Bilateral, staged, simultaneous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Calgary
  • Concordia Hospital
  • St. Joseph's - McMaster University
  • Kingston Health Sciences Center - KGH
  • London Health Sciences Centre
  • Ottawa Hospital Research Institute
  • St. Michael's Hospital
  • McGill University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Total Knee Arthroplasty (TKA)

Unicompartmental Knee Arthroplasty (UKA)

Arm Description

Patient will have complete replacement - Simultaneous vs Staged

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Return to work
Assessment of ability to return to work and time away from work following surgery.
Patient satisfaction
Evaluate change in patient-reported satisfaction using a Likaert scale; 1=Very Satisfied to 5=Very Unsatisfied.
Complications
Evaluation type and frequency of complication (adverse events).
Hospital stay
Number of days in hospital
Transfusion rate
Number of unit transfused during hospital stay.
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.

Full Information

First Posted
June 11, 2018
Last Updated
June 26, 2023
Sponsor
Orthopaedic Innovation Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03564730
Brief Title
Staged Versus Simultaneous Bilateral Knee Arthroplasty
Official Title
Randomized Control Trial of Staged Versus Simultaneous Bilateral Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthopaedic Innovation Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Bilateral, staged, simultaneous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to either simultaneous or staged bilateral KA procedures using randomly generated numbers permuted in blocks of 10.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Total Knee Arthroplasty (TKA)
Arm Type
Active Comparator
Arm Description
Patient will have complete replacement - Simultaneous vs Staged
Arm Title
Unicompartmental Knee Arthroplasty (UKA)
Arm Type
Active Comparator
Arm Description
Patient will have half-knee replacement (partial) - Simultaneous vs Staged
Intervention Type
Procedure
Intervention Name(s)
Simultaneous Knee Arthroplasty (UKA)
Intervention Description
Patient will have both knees completed under one anesthetic.
Intervention Type
Procedure
Intervention Name(s)
Staged Knee Arthroplasty (UKA)
Intervention Description
Patient will have knees completed under 2 anesthetics.
Primary Outcome Measure Information:
Title
Veterans Rand 12-item Health Survey Score (VR-12)
Description
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.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Joint function (Oxford-12 knee score)
Description
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.
Time Frame
Pre-operative, 6 months, 12 months, 18 months, 24 months
Title
Return to work
Description
Assessment of ability to return to work and time away from work following surgery.
Time Frame
Pre-operative, 6 months, 12 months, 18 months, 24 months
Title
Patient satisfaction
Description
Evaluate change in patient-reported satisfaction using a Likaert scale; 1=Very Satisfied to 5=Very Unsatisfied.
Time Frame
6 months, 12 months, 18 months, 24 months
Title
Complications
Description
Evaluation type and frequency of complication (adverse events).
Time Frame
Intraoperative, 6 months, 12 months, 18 months, 24 months
Title
Hospital stay
Description
Number of days in hospital
Time Frame
Up to 1 week
Title
Transfusion rate
Description
Number of unit transfused during hospital stay.
Time Frame
Up to 1 week
Title
Costs of knee replacement surgery
Description
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.
Time Frame
Up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric R. Bohm, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2P 3C5
Country
Canada
Facility Name
Concordia Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K 3S8
Country
Canada
Facility Name
St. Joseph's - McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Kingston Health Sciences Center - KGH
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
McGill University
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 0G4
Country
Canada

12. IPD Sharing Statement

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Staged Versus Simultaneous Bilateral Knee Arthroplasty

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