RSA of the ATTUNE Knee System: RCT Comparing Traditional Vs Enhanced-Fixation Device Designs

Knee Osteoarthritis Clinical Trial

Official title:

Radiostereometric Analysis (RSA) of the ATTUNE Knee System: A Randomized Controlled Trial Comparing Traditional Versus Enhanced-Fixation Device Designs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554720
• Other study ID #: HS21601
• Status: Completed
• Phase: N/A
• Start date: July 4, 2018
• Est. completion date: January 15, 2024

Study information

• Verified date: January 2024
• Source: Canadian Radiostereometric Analysis Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 15, 2024
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• ATTUNE PS Knee
The ATTUNE PS Knee is the standard implants.
• ATTUNE S+ PS Knee
The ATTUNE S+ PS Knee is the enhanced fixation.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	Concordia Hospital	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
Canadian Radiostereometric Analysis Network	Dalhousie University, London Health Sciences Centre, Orthopaedic Innovation Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RSA Migration	Migration of the tibial and femoral components between the 2 device designs.	2 Years
Secondary	Knee Replacement Expectation Survey (KRES)	The KRES is a patient reported questionnaire that consists of 19 questions. The questions ask how each expectation is important in the treatment of the knee. The scale is rated: 1 (Very important) to 5 (This does not apply to me). The score ranges from 19 to 95 with higher scores associated with higher expectations.	Preoperative
Secondary	European Quality of Life (EQ-5D-5L)	Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments. The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.	Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Secondary	Pain score	Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable)	Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Secondary	Patient satisfaction	Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported pain severity as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied)	Preoperative, 6 Months, 1 Year and 2 Years
Secondary	Oxford 12 Knee	Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in functional outcomes assessments, patient reported outcome	Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years
Secondary	University of California at Los Angeles (UCLA) Activity Level scale	Evaluate and compare the change in UCLA activity score compared to baseline in the study cohort. UCLA activity scores range from 1 to 10, and is a measure of activity with 10 being most active.	Preoperative, 6 Months, 1 Year and 2 Years]
Secondary	Pain Catastrophizing Scale (PCS)	The patient are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain. Each PCS item is rated on a 5-point scale: 0 (not at all) to 4 (all the time). The PCS total score is computed by summing responses to the 13 items. PCS total scores range from 0 - 52.	Preoperative and 1 Year
Secondary	Pre-operative Patient's Knee Implant Performance (PKIP)	The Pre-surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient reported questionnaire that consists of 24 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likaert- like response option.	Preoperative, 6 Months, 1 Year and 2 Years
Secondary	Patient complications	Evaluate the type and frequency of the complications/adverse events.	Preoperative, 1 Week, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years