Trials / Active Not Recruiting
Active Not RecruitingNCT03865667
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Preserve Femoral Stem
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 63 (actual)
- 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 | PROFEMUR® Preserve Femoral Stem | Total Hip Total Hip Arthroscopy |
Timeline
- Start date
- 2019-01-15
- Primary completion
- 2032-01-01
- Completion
- 2032-01-01
- First posted
- 2019-03-07
- Last updated
- 2023-04-28
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03865667. Inclusion in this directory is not an endorsement.