Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Anatomic (Femur First) to Neutral Mechanical Alignment Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 4
- Primary Endpoint
- Implant migration
Study Overview
Brief Summary
The purpose of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system using model-based RSA over the first 2 post-operative years.
Detailed Description
This is a multi-centre, randomized controlled trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune S+ fixed bearing TKR system. Patients will be randomized to two study groups:
- Neutral mechanical alignment;
- Anatomical alignment.
The principal objective of this study is to compare migration patterns between mechanical and anatomic alignment surgical techniques for the Attune S+ CR-FB knee system 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, comparison of functional and health status of subjects following surgery, comparison of intra-operative soft-tissue releases, incidence of complications and adverse events, and to assess several health economic parameters relating to the surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The patient will not be informed of their study allocation.
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
- •Varus knee deformity of 0 to 10 degrees
- •Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
- •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
- •Inflammatory arthropathy
- •Prior patellectomy
- •PCL deficiency
- •Major Coronal plane deformity
- •Valgus alignment
- •Bone defects requiring augments, cones and/or stemmed implants
- •Body Mass Index 45 or more
Outcomes
Primary Outcomes
Implant migration
Time Frame: 2 years
Measured via radiosteriometric analysis (RSA)
Secondary Outcomes
- Patient satisfaction: VAS(Preoperative, 3 Months, 6 Months, 1 Year, 2 Years)
- Patient complications(Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 2 Years)
- Oxford-12 knee score(Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Pain VAS(Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 2 Years)
- Peri-operative pain management(Intraoperative)
- Blood loss(Intraoperative)
- Pain Catastrophizing Scale (PCS)(Pre-operative, 12 months)
- 7. University of California at Los Angeles (UCLA) Activity Level scale(Pre-operative, 6 months, 1 year, 2 years)
- Hospital stay(Up to 1 week)
- European Quality of Life (EQ-5D-5L)(Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Pre-operative Patient's Knee Implant Performance (PKIP)(Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years)
- Length of surgery(Intraoperative)
- Tourniquet time(Intraoperative)
- Anesthesia type(Intraoperative)
- Soft tissue release(Intraoperative)