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Completed

NCT Number: NCT03554720

RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs

The principal objective of this study is to compare migration patterns between the Attune and Attune S+ PS knee systems using model-based RSA over the first 2 post-operative years. Secondary objectives include; comparison of 2-year migration values against published thresholds for adequate short-term fixation, quantify changes in functional and health status of subjects following surgery and compare between study groups, and assess occurrences of complications following surgery.

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Key information

Conditions

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

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Concordia Hospital, Winnipeg, Manitoba, Canada

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About this study

This is a multi-centre, randomized controlled trial of patients undergoing posterior-stabilized total knee arthroplasty. In this study, the investigators propose to randomize 50 subjects to receive either the standard Attune PS TKA (n=25) or the enhanced fixation Attune S+ PS TKA (n=25) and follow them for a period of 2 years post-operatively. The primary outcome of the study will be stability of fixation of the tibial baseplate as measured by model-based RSA. Secondary outcomes will be to determine the functionality of patients after surgery using self-reported questionnaires.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
  • Between the ages of 21 and 80 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent

Exclusion criteria

  • Active or prior infection
  • Medical condition precluding major surgery

Treatment and study plan

ATTUNE PS Knee

Device

The ATTUNE PS Knee is the standard implants.

ATTUNE S+ PS Knee

Device

The ATTUNE S+ PS Knee is the enhanced fixation.

Primary outcomes

  1. RSA Migration

    Time frame: 2 Years

    Migration of the tibial and femoral components between the 2 device designs.

Secondary outcomes

  1. Knee Replacement Expectation Survey (KRES)

    Time frame: Preoperative

    The KRES is a patient reported questionnaire that consists of 19 questions. The questions ask how each expectation is important in the treatment of the knee. The scale is rated: 1 (Very important) to 5 (This does not apply to me). The score ranges from 19 to 95 with higher scores associated with higher expectations.

  2. European Quality of Life (EQ-5D-5L)

    Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years

    Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments. The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.

  3. Pain score

    Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years

    Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable)

  4. Patient satisfaction

    Time frame: Preoperative, 6 Months, 1 Year and 2 Years

    Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported pain severity as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied)

  5. Oxford 12 Knee

    Time frame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years

    Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments, patient reported outcome

  6. University of California at Los Angeles (UCLA) Activity Level scale

    Time frame: Preoperative, 6 Months, 1 Year and 2 Years]

    Evaluate and compare the change in UCLA activity score compared to baseline in the study cohort. UCLA activity scores range from 1 to 10, and is a measure of activity with 10 being most active.

  7. Pain Catastrophizing Scale (PCS)

    Time frame: Preoperative and 1 Year

    The patient are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain. Each PCS item is rated on a 5-point scale: 0 (not at all) to 4 (all the time). The PCS total score is computed by summing responses to the 13 items. PCS total scores range from 0 - 52.

  8. Pre-operative Patient's Knee Implant Performance (PKIP)

    Time frame: Preoperative, 6 Months, 1 Year and 2 Years

    The Pre-surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient reported questionnaire that consists of 24 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likaert- like response option.

  9. Patient complications

    Time frame: Preoperative, 1 Week, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years

    Evaluate the type and frequency of the complications/adverse events.

Sponsors and collaborators

Lead sponsor

Canadian Radiostereometric Analysis Network

Other

Collaborators

  • Dalhousie University
  • London Health Sciences Centre
  • Orthopaedic Innovation Centre

Registry information

Official study title

Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Traditional Versus Enhanced-Fixation Device Designs

Important dates

Study start
2018
Primary completion
2021
Study completion
2024
First posted
Jun 13, 2018
Registry last updated
Jan 17, 2024

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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