Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Traditional Versus Enhanced-Fixation Device Designs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 4
- Primary Endpoint
- RSA Migration
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
RSA Migration
Time Frame: 2 Years
Migration of the tibial and femoral components between the 2 device designs.
Secondary Outcomes
- 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)
- University of California at Los Angeles (UCLA) Activity Level scale(Preoperative, 6 Months, 1 Year and 2 Years])
- Pre-operative Patient's Knee Implant Performance (PKIP)(Preoperative, 6 Months, 1 Year and 2 Years)
- Knee Replacement Expectation Survey (KRES)(Preoperative)
- Pain Catastrophizing Scale (PCS)(Preoperative and 1 Year)
- Patient complications(Preoperative, 1 Week, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years)