NCT01064531

Mini Stem Radiostereometric Analysis Study

A Randomized Controlled Trial to Compare Implant Migration of the MIS Stem Versus The Synergy Total Hip System by Radiostereometric Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to assess migration of the MIS Stem compared to the Synergy Hip System using Radiostereometric Analysis (RSA), and to assess the long-term safety and effectiveness of the study device. This study will document any device-related surgical or post-operative complications and adverse radiographic observations. Subjects meeting the entrance criteria specified in this protocol will be randomized as they become available.

Detailed description

The purpose of the current investigation is to compare migration of the device after implantation with a modular, short hip stem called the "MIS Stem" or a standard THA using the Synergy Hip System using RSA. The intended use of this product is for patients with inflammatory and non-inflammatory degenerative joint disease who require a primary total hip replacement.

Conditions

• Osteoarthritis, Hip

Interventions

Type	Name	Description
DEVICE	MIS Femoral Neck Stem implant

Timeline

• Start date: 2009-06-30
• Primary completion: 2016-04-22
• Completion: 2016-04-22
• First posted: 2010-02-08
• Last updated: 2020-04-09
• Results posted: 2020-04-09

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study