Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System

NCT04079751 | Completed

• 1 other identifier: B2018-139
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Implant migration

  Measured via radiosteriometric analysis (RSA)

  2 years

Secondary Outcomes (15)

• Oxford-12 knee score

  Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years

• Pain Catastrophizing Scale (PCS)

  Pre-operative, 12 months

• 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

• 7. University of California at Los Angeles (UCLA) Activity Level scale

  Pre-operative, 6 months, 1 year, 2 years

Study Arms (2)

Neutral Mechanical Alignment

ACTIVE COMPARATOR

Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment

Procedure: Neutral Mechanical Alignment

Anatomical Alignment

ACTIVE COMPARATOR

Total knee arthroplasty: Neutral Mechanical Alignment vs Anatomical Alignment

Procedure: Anatomical Alignment

Interventions

Neutral Mechanical Alignment PROCEDURE

Hip-knee-ankle angle of 180° ± 3°.

Neutral Mechanical Alignment

Anatomical Alignment PROCEDURE

Restoring a patient's pre-diseased limb alignment

Anatomical Alignment

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Radiostereometric Analysis Network: lead

Study Sites (2)

Concordia Hospital

Winnipeg, Manitoba, R2K 3S8, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Thomas Turgeon

  Concordia Joint Replacement Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will not be informed of their study allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to either Neutral mechanical alignment or Anatomical alignment using randomly generated numbers permuted in blocks of 4.

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: September 6, 2019
• Study Start: May 5, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

CA (2)