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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