Trials / Active Not Recruiting
Active Not RecruitingNCT02314702
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 26 (actual)
- Sponsor
- MicroPort Orthopedics Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PROFEMUR® L Revision Femoral Stem | Revision Total Hip Arthroplasty |
Timeline
- Start date
- 2015-09-04
- Primary completion
- 2026-10-01
- Completion
- 2027-10-01
- First posted
- 2014-12-11
- Last updated
- 2022-10-13
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02314702. Inclusion in this directory is not an endorsement.