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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 3, 2021

Detailed Description

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.

Interventions

  • Device: ATTUNE PS Knee
    • The ATTUNE PS Knee is the standard implants.
  • Device: ATTUNE S+ PS Knee
    • The ATTUNE S+ PS Knee is the enhanced fixation.

Arms, Groups and Cohorts

  • Active Comparator: Standard implants
    • ATTUNE PS Knee
  • Active Comparator: Enhanced-Fixation
    • ATTUNE S+ PS Knee

Clinical Trial Outcome Measures

Primary Measures

  • RSA Migration
    • Time Frame: 2 Years
    • Migration of the tibial and femoral components between the 2 device designs.

Secondary Measures

  • 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.
  • 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.
  • 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)
  • 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)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Canadian Radiostereometric Analysis Network
  • Collaborator
    • Orthopaedic Innovation Centre
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thomas Turgeon, MD MPH FRCSC, Principal Investigator, University of Manitoba
    • Glen Richardson, MD MSc FRCSC, Principal Investigator, Dalhousie University
    • Douglas Naudie, MD FRCSC, Principal Investigator, London Health Sciences Centre

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