Clinical trial NCT03554720: RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs
Official title: Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Traditional Versus Enhanced-Fixation Device Designs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Canadian Radiostereometric Analysis Network
Sponsor class: OTHER
Collaborators: name: Orthopaedic Innovation Centre
name: Dalhousie University
name: London Health Sciences Centre
First posted: 2018-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The principal objective of this study is to compare migration patterns between the Attune and Attune S+ PS knee systems 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, quantify changes in functional and health status of subjects following surgery and compare between study groups, and assess occurrences of complications following surgery.

Detailed description: This is a multi-centre, randomized controlled trial of patients undergoing posterior-stabilized total knee arthroplasty. In this study, the investigators propose to randomize 50 subjects to receive either the standard Attune PS TKA (n=25) or the enhanced fixation Attune S+ PS TKA (n=25) and follow them for a period of 2 years post-operatively. The primary outcome of the study will be stability of fixation of the tibial baseplate as measured by model-based RSA. Secondary outcomes will be to determine the functionality of patients after surgery using self-reported questionnaires.

Eligibility criteria: Inclusion Criteria:

* Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
* 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

Exclusion Criteria:

* Active or prior infection
* Medical condition precluding major surgery

Primary outcomes:
measure: RSA Migration
timeFrame: 2 Years
Secondary outcomes:
measure: Knee Replacement Expectation Survey (KRES)
timeFrame: Preoperative
measure: European Quality of Life (EQ-5D-5L)
timeFrame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
measure: Pain score
timeFrame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
measure: Patient satisfaction
timeFrame: Preoperative, 6 Months, 1 Year and 2 Years
measure: Oxford 12 Knee
timeFrame: Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
measure: University of California at Los Angeles (UCLA) Activity Level scale
timeFrame: Preoperative, 6 Months, 1 Year and 2 Years]
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Preoperative and 1 Year
measure: Pre-operative Patient's Knee Implant Performance (PKIP)
timeFrame: Preoperative, 6 Months, 1 Year and 2 Years
measure: Patient complications
timeFrame: Preoperative, 1 Week, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
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: University of Manitoba
name: Thomas Turgeon, MD MPH FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Glen Richardson, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Centre
name: Douglas Naudie, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References: