NCT03564730

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?"

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
6mo left

Started Mar 2018

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2018Dec 2026

Study Start

First participant enrolled

March 19, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

8 years

First QC Date

June 11, 2018

Last Update Submit

February 19, 2026

Conditions

Knee Osteoarthritis

Keywords

Bilateral, staged, simultaneous

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Joint function (Oxford-12 knee score)

    Pre-operative, 6 months, 12 months, 18 months, 24 months

  • Return to work

    Pre-operative, 6 months, 12 months, 18 months, 24 months

  • Patient satisfaction

    6 months, 12 months, 18 months, 24 months

  • Complications

    Intraoperative, 6 months, 12 months, 18 months, 24 months

  • Hospital stay

    Up to 1 week

  • +2 more secondary outcomes

Study Arms (2)

Total Knee Arthroplasty (TKA)

ACTIVE COMPARATOR

Patient will have complete replacement - Simultaneous vs Staged

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

Unicompartmental Knee Arthroplasty (UKA)

ACTIVE COMPARATOR

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

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

Interventions

Simultaneous Knee Arthroplasty (UKA)PROCEDURE

Patient will have both knees completed under one anesthetic.

Total Knee Arthroplasty (TKA)Unicompartmental Knee Arthroplasty (UKA)
Staged Knee Arthroplasty (UKA)PROCEDURE

Patient will have knees completed under 2 anesthetics.

Total Knee Arthroplasty (TKA)Unicompartmental Knee Arthroplasty (UKA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Calgary

Calgary, Alberta, T2P 3C5, Canada

Location

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

Location

St. Joseph's - McMaster University

Hamilton, Ontario, L8N 4A6, Canada

Location

Kingston Health Sciences Center - KGH

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

McGill University

Montreal, Quebec, H3A 0G4, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Eric R. Bohm, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized to either simultaneous or staged bilateral KA procedures using randomly generated numbers permuted in blocks of 10.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

June 21, 2018

Study Start

March 19, 2018

Primary Completion

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations

CA(8)