NCT01746524

Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System

Prospective, Single Arm Multiconfiguration Investigation to Assess Functional Performance of Attune™ Primary Total Knee Arthroplasty System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,138 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one of four contemporary knee configurations will be pooled to establish a contemporary dataset. The primary objective of this study is to evaluate the pre-operative (approximately -90 to -1 day before surgery) to minimum one year (approximately 304 to 668 days) postoperative functional performance improvement for the Attune™ primary, cemented TKA system as measured by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score (KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining rotating platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and posterior stabilized rotating platform (Attune™ PS RP).

Detailed description

The study is designed as a prospective, single arm stratified, multi-center investigation. Approximately 20 study sites, worldwide, will enroll 1040 subjects (1040 knees). Each study is expected to enroll approximately 52 subjects (approximately 52 knees). An additional 10 subjects per site may be recruited at sites which have Sub-Investigators participating in the study. Cohort reallocation is permitted. There will be no control group. One thousand and forty (1040)Subjects will be stratified into 4 subgroups of 260: cruciate retaining fixed bearing(CR FB), posterior stabilized fixed bearing (PS FB), cruciate retaining rotating platform (CR RP), and posterior stabilized rotating platform (PS RP). Treatment assignment in this study is not randomized. Each site will only enroll patients in one of the four knee configuration sub-groups most commonly used as their standard of care.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DEVICE	ATTUNE Primary Total Knee Arthroplasty	Patients will undergo a primary, cemented total knee replacement using one of the four configurations of the Attune knee (CR FB, PS FB, CR RP, PS RP).

Timeline

• Start date: 2012-11-01
• Primary completion: 2018-03-05
• Completion: 2018-03-05
• First posted: 2012-12-11
• Last updated: 2019-04-11

Locations

20 sites across 4 countries: United States, Australia, New Zealand, United Kingdom