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ACTIVE NOT RECRUITING
NCT02239783

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems

Sponsor: MicroPort Orthopedics Inc.

View on ClinicalTrials.gov

Summary

Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have 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

143

Start Date

2014-11

Completion Date

2028-11

Last Updated

2023-11-18

Healthy Volunteers

No

Conditions

Interventions

DEVICE

total hip arthroplasty implant

Locations (1)

Ottawa Hospital

Ottawa, Ontario, Canada