NCT01464645

Post-Market Study of the Modular Revision Hip System

Prospective Multicenter Open Label Study Examining the Short-term Safety and Efficacy of the Modular Revision Hip System (MRHS)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Encore Medical, L.P. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the short term efficacy of the MRH system as well as determine if operating room time is decreased using this simple, two-tray system.

Detailed description

The main goal of Revision Total Hip Arthroplasty (THA) is to restore the patient's hip function by repairing the patient's kinematics. However, a revision hip surgery represents a challenge for even the most experienced surgeon. Loss of bone stock, joint stability, infection, fracture, trochanteric non-union, and difficulty in implant or cement removal are all potential issues that a surgeon must consider for each presenting patient. These challenges require hip implant systems to provide an intraoperative flexibility that is not normally required for primary THA. The Lima Modular Revision Hip System uses modular stem and neck components to allow for surgical versatility when selecting leg length, offset and version. The purpose of this study is to examine the short term safety and efficacy of the Modular Revision Hip System (MHRS) using radiologic success and Harris Hip Scores as endpoints. The study will take place at multiple sites across the United States and will include only subjects who meet the indications for use criteria for the Modular Revision Hip system and who are candidates for revision hip replacement surgery. Target enrollment will be 200 subjects with up to 25 subjects at 15 sites across the United States.

Conditions

• Aseptic Loosening
• Osteolysis
• Traumatic Fracture
• Failed Total Hip Implant

Interventions

Type	Name	Description
DEVICE	Modular Revision Hip System	Hip System that is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.

Timeline

• Start date: 2012-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2011-11-03
• Last updated: 2018-10-10

Locations

6 sites across 1 country: United States