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

Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Traditional Versus 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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: ATTUNE PS Knee; Device: ATTUNE S+ PS Knee

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 3S8
      • Concordia Hospital
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard implants; ATTUNE PS Knee	Device: ATTUNE PS Knee; The ATTUNE PS Knee is the standard implants.
Active Comparator: Enhanced-Fixation; ATTUNE S+ PS Knee	Device: ATTUNE S+ PS Knee; The ATTUNE S+ PS Knee is the enhanced fixation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RSA Migration	Migration of the tibial and femoral components between the 2 device designs.	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Replacement Expectation Survey (KRES)	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.	Preoperative
European Quality of Life (EQ-5D-5L)	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.	Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Pain score	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)	Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Patient satisfaction	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)	Preoperative, 6 Months, 1 Year and 2 Years
Oxford 12 Knee	Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments, patient reported outcome	Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
University of California at Los Angeles (UCLA) Activity Level scale	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.	Preoperative, 6 Months, 1 Year and 2 Years]
Pain Catastrophizing Scale (PCS)	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.	Preoperative and 1 Year
Pre-operative Patient's Knee Implant Performance (PKIP)	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.	Preoperative, 6 Months, 1 Year and 2 Years
Patient complications	Evaluate the type and frequency of the complications/adverse events.	Preoperative, 1 Week, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years

Collaborators and Investigators

• Sponsor: Canadian Radiostereometric Analysis Network
• Collaborators: Dalhousie University; London Health Sciences Centre; Orthopaedic Innovation Centre
• Investigators: Principal Investigator: Thomas Turgeon, MD MPH FRCSC, University of Manitoba; Principal Investigator: Glen Richardson, MD MSc FRCSC, Dalhousie University; Principal Investigator: Douglas Naudie, MD FRCSC, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2018
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): January 15, 2024

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HS21601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes