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ACTIVE NOT RECRUITING
NCT02314702

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems

Sponsor: MicroPort Orthopedics Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

OBSERVATIONAL

Enrollment

26

Start Date

2015-09-04

Completion Date

2027-10

Last Updated

2022-10-13

Healthy Volunteers

No

Conditions

Interventions

DEVICE

PROFEMUR® L Revision Femoral Stem

Revision Total Hip Arthroplasty

Locations (1)

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom