Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components
NCT02285842 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 143
Last updated 2023-06-07
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.
Conditions
- Joint Disease
Interventions
- DEVICE
-
Primary hip resurfacing device
CONSERVE® Press-Fit Femoral Components
Sponsors & Collaborators
-
MicroPort Orthopedics Inc.
lead INDUSTRY
Principal Investigators
-
Paul Beaule, MD · Ottawa Hospital Research Institute
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-12-31
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
Countries
- Canada
Study Locations
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