NCT02285842

Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 143 (actual)
• Sponsor: MicroPort Orthopedics Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

Detailed description

MicroPort Orthopedics Inc. (MPO) currently markets several total hip arthroplasty (THA) and resurfacing components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these components. The objectives of this study are to evaluate component survivorship, total functional outcome scores, and radiographic outcomes of implanted subjects at out to 10 years follow-up.

Conditions

• Joint Disease

Interventions

Type	Name	Description
DEVICE	Primary hip resurfacing device	CONSERVE® Press-Fit Femoral Components

Timeline

• Start date: 2014-12-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2014-11-07
• Last updated: 2023-06-07

Locations

1 site across 1 country: Canada