Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System

NCT ID: NCT04079751

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-05
• Study Completion Date: 2022-02-01

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:

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neutral Mechanical Alignment

Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment

Group Type: ACTIVE_COMPARATOR

Neutral Mechanical Alignment

Intervention Type: PROCEDURE

Hip-knee-ankle angle of 180° ± 3°.

Anatomical Alignment

Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment

Group Type: ACTIVE_COMPARATOR

Anatomical Alignment

Intervention Type: PROCEDURE

Restoring a patient's pre-diseased limb alignment

Interventions

Neutral Mechanical Alignment

Hip-knee-ankle angle of 180° ± 3°.

Intervention Type: PROCEDURE

Anatomical Alignment

Restoring a patient's pre-diseased limb alignment

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Radiostereometric Analysis Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Turgeon

Role: PRINCIPAL_INVESTIGATOR

Concordia Joint Replacement Group

Locations

Concordia Hospital

Winnipeg, Manitoba, Canada

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Other Identifiers

B2018-139

Identifier Type: -

Identifier Source: org_study_id