Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Knee Osteoarthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be randomized to either Neutral mechanical alignment or Anatomical alignment using randomly generated numbers permuted in blocks of 4.Masking: Single (Participant)Masking Description: The patient will not be informed of their study allocation.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 80 years
- Gender
- Both males and females
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 stud...
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.
Tracking Information
- NCT #
- NCT04079751
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Thomas Turgeon Concordia Joint Replacement Group
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