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NCT Number: NCT03564730

Staged Versus Simultaneous Bilateral 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?"

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simultaneous Knee Arthroplasty (UKA)

Procedure

Patient will have both knees completed under one anesthetic.

Staged Knee Arthroplasty (UKA)

Procedure

Patient will have knees completed under 2 anesthetics.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Orthopaedic Innovation Centre

Other

Registry information

Official study title

Randomized Control Trial of Staged Versus Simultaneous Bilateral Total Knee Arthroplasty

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2018
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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