Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System

Canadian Radiostereometric Analysis Network

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Procedure: Anatomical Alignment; Procedure: Neutral Mechanical Alignment

Study type: Interventional

Funder types: Other

Identifiers

NCT04079751

B2018-139

Details and patient eligibility

About

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.

Full 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:

1. Neutral mechanical alignment;
2. 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.

Enrollment: 52 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
2. Varus knee deformity of 0 to 10 degrees
3. Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
4. Between the ages of 21 and 80 inclusive
5. Patients willing and able to comply with follow-up requirements and self-evaluations
6. Ability to give informed consent

Exclusion criteria

1. Active or prior infection
2. Medical condition precluding major surgery
3. Inflammatory arthropathy
4. Prior patellectomy
5. PCL deficiency
6. Major Coronal plane deformity
7. Valgus alignment
8. Bone defects requiring augments, cones and/or stemmed implants
9. Body Mass Index 45 or more

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Neutral Mechanical Alignment

Active Comparator group

Description:

Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment

Treatment:

Procedure: Neutral Mechanical Alignment

Anatomical Alignment

Active Comparator group

Description:

Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment

Treatment:

Procedure: Anatomical Alignment