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Staged Versus Simultaneous Bilateral Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03564730
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Orthopaedic Innovation Centre

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?"

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Simultaneous Knee Arthroplasty (UKA) Procedure: Staged Knee Arthroplasty (UKA) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Staged Versus Simultaneous Bilateral Total Knee Arthroplasty
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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.




Primary Outcome Measures :
  1. Veterans Rand 12-item Health Survey Score (VR-12) [ Time Frame: 1 Year ]
    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 :
  1. Joint function (Oxford-12 knee score) [ Time Frame: Pre-operative, 6 months, 12 months, 18 months, 24 months ]
    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.

  2. Return to work [ Time Frame: Pre-operative, 6 months, 12 months, 18 months, 24 months ]
    Assessment of ability to return to work and time away from work following surgery.

  3. Patient satisfaction [ Time Frame: 6 months, 12 months, 18 months, 24 months ]
    Evaluate change in patient-reported satisfaction using a Likaert scale; 1=Very Satisfied to 5=Very Unsatisfied.

  4. Complications [ Time Frame: Intraoperative, 6 months, 12 months, 18 months, 24 months ]
    Evaluation type and frequency of complication (adverse events).

  5. Hospital stay [ Time Frame: Up to 1 week ]
    Number of days in hospital

  6. Transfusion rate [ Time Frame: Up to 1 week ]
    Number of unit transfused during hospital stay.

  7. Costs of knee replacement surgery [ Time Frame: Up to 1 week ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564730


Contacts
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Contact: Sarah Tran 204-926-1231 stran@orthoinno.com
Contact: Trevor Gascoyne 204-926-1235 tgascoyne@orthoinno.com

Locations
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Canada, Manitoba
Concordia Hospital Recruiting
Winnipeg, Manitoba, Canada, R2K 3S8
Contact: Sarah Tran    204-926-1231    stran@orthoinno.com   
Contact: Trevor Gascoyne    204-926-1235    tgascoyne@orthoinno.com   
Principal Investigator: Eric Bohm, MD MSc FRCSC         
Sub-Investigator: David Hedden, MD FRCSC         
Sub-Investigator: Colin Burnell, MD FRCSC         
Sub-Investigator: Thomas Turgeon, MD MPH FRCSC         
Canada, Ontario
St. Joseph's - McMaster University Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Breanne Flood       bflood@stjosham.on.ca   
Principal Investigator: Vickas Khanna, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Eva Galos       Eva.Galos@lhsc.on.ca   
Principal Investigator: Edward Vasarhelyi, MD         
Sub-Investigator: James Howard, MD         
Sub-Investigator: Brent Lanting, MD         
Sub-Investigator: Steven MacDonald, MD         
Sub-Investigator: Douglas Naudie, MD         
Sub-Investigator: Richard McCalden, MD         
Sub-Investigator: Emil Schemitsch, MD         
Canada, Quebec
McGill University Not yet recruiting
Montréal, Quebec, Canada, H3A 0G4
Contact: Karen Smith       karenwall@hotmail.com   
Principal Investigator: Michael Tanzer, MD         
Sponsors and Collaborators
Orthopaedic Innovation Centre
Investigators
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Principal Investigator: Eric R. Bohm, MD University of Manitoba

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Responsible Party: Orthopaedic Innovation Centre
ClinicalTrials.gov Identifier: NCT03564730    
Other Study ID Numbers: B2017-046
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Orthopaedic Innovation Centre:
Bilateral, staged, simultaneous
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases