NCT02574312

ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty

Comparison of Alignment Achieved Using Single-Use Versus Reusable Instrumentation in Total Knee Arthroplasty (TKA): A Prospective, Non-Randomized Multi-center Investigation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee Arthroplasty.

Detailed description

This study is designed as comparative, sequential, non-randomized, multi-center investigation. Up to four sites will recruit approximately 88 subjects. Each site is expected to implant the ATTUNE primary cemented total knee in approximately 22 subjects. The sequential design requires all ATTUNE TKA with reusable instruments be completed before doing any ATTUNE TKA with single use instruments. The mechanical axis alignment will be assessed at the 3 month follow-up by independent radiographic review.

Conditions

• Osteoarthritis
• Post-traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	ATTUNE TKA with ATTUNE RUI	ATTUNE TKA with ATTUNE RUI
DEVICE	ATTUNE TKA with ATTUNE SUI	ATTUNE TKA with ATTUNE SUI

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-03-28
• Completion: 2019-03-28
• First posted: 2015-10-12
• Last updated: 2020-04-09
• Results posted: 2020-04-09

Locations

4 sites across 2 countries: United States, United Kingdom