Trials / Enrolling By Invitation
Enrolling By InvitationNCT03576573
Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 143 (estimated)
- Sponsor
- MicroPort Orthopedics Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PROCOTYL® C | Hip Arthroplasty |
Timeline
- Start date
- 2019-03-27
- Primary completion
- 2032-12-01
- Completion
- 2032-12-01
- First posted
- 2018-07-03
- Last updated
- 2023-11-14
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03576573. Inclusion in this directory is not an endorsement.