Trials / Withdrawn
WithdrawnNCT02507258
PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (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) and resurfacing components marketed in the European Union (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 the medial device directives (MEDDEV) 2.12/2 rev 2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell | PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component |
Timeline
- Start date
- 2017-12-01
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2015-07-23
- Last updated
- 2018-06-07
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02507258. Inclusion in this directory is not an endorsement.