Clinical trial NCT04079751: Trial Comparing Alignment Techniques - RSA of ATTUNE Knee System
Official title: Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Anatomic (Femur First) to Neutral Mechanical Alignment Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Canadian Radiostereometric Analysis Network
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either Neutral mechanical alignment or Anatomical alignment using randomly generated numbers permuted in blocks of 4.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Implant migration
timeFrame: 2 years
Secondary outcomes:
measure: Oxford-12 knee score
timeFrame: Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Pre-operative, 12 months
measure: European Quality of Life (EQ-5D-5L)
timeFrame: Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Pre-operative Patient's Knee Implant Performance (PKIP)
timeFrame: Pre-operative, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: 7. University of California at Los Angeles (UCLA) Activity Level scale
timeFrame: Pre-operative, 6 months, 1 year, 2 years
measure: Pain VAS
timeFrame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 2 Years
measure: Patient satisfaction: VAS
timeFrame: Preoperative, 3 Months, 6 Months, 1 Year, 2 Years
measure: Patient complications
timeFrame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year, 2 Years
measure: Hospital stay
timeFrame: Up to 1 week
measure: Tourniquet time
timeFrame: Intraoperative
measure: Length of surgery
timeFrame: Intraoperative
measure: Blood loss
timeFrame: Intraoperative
measure: Anesthesia type
timeFrame: Intraoperative
measure: Peri-operative pain management
timeFrame: Intraoperative
measure: Soft tissue release
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Concordia Hospital
state: Manitoba
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Concordia Joint Replacement Group
name: Thomas Turgeon
role: PRINCIPAL_INVESTIGATOR
References: