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

Osteoarthritis Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Osteoarthritis
• Post-traumatic Arthritis

• NCT number: NCT02574312
• Study type: Interventional
• Source: DePuy Orthopaedics
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Completion date: March 28, 2019