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ENROLLING BY INVITATION
NCT03576573

Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components

Sponsor: MicroPort Orthopedics Inc.

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

OBSERVATIONAL

Enrollment

143

Start Date

2019-03-27

Completion Date

2032-12

Last Updated

2023-11-14

Healthy Volunteers

No

Conditions

Interventions

DEVICE

PROCOTYL® C

Hip Arthroplasty

Locations (1)

Elbe Kliniken Buxtehude

Buxtehude, Germany