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
1 other identifier
interventional
50
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable knee-osteoarthritis
Started Jul 2018
Longer than P75 for not_applicable knee-osteoarthritis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2018
CompletedStudy Start
First participant enrolled
July 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2024
CompletedJanuary 17, 2024
January 1, 2024
3.3 years
May 18, 2018
January 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
RSA Migration
Migration of the tibial and femoral components between the 2 device designs.
2 Years
Secondary Outcomes (9)
Knee Replacement Expectation Survey (KRES)
Preoperative
European Quality of Life (EQ-5D-5L)
Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Pain score
Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Patient satisfaction
Preoperative, 6 Months, 1 Year and 2 Years
Oxford 12 Knee
Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
- +4 more secondary outcomes
Study Arms (2)
Standard implants
ACTIVE COMPARATORATTUNE PS Knee
Enhanced-Fixation
ACTIVE COMPARATORATTUNE S+ PS Knee
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Active or prior infection
- Medical condition precluding major surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Radiostereometric Analysis Networklead
- Orthopaedic Innovation Centrecollaborator
- Dalhousie Universitycollaborator
- London Health Sciences Centrecollaborator
Study Sites (2)
Concordia Hospital
Winnipeg, Manitoba, R2K 3S8, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2018
First Posted
June 13, 2018
Study Start
July 4, 2018
Primary Completion
November 3, 2021
Study Completion
January 15, 2024
Last Updated
January 17, 2024
Record last verified: 2024-01