Trials / Active Not Recruiting
Active Not RecruitingNCT02823834
PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components
Post Market Clinical Follow-up Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 121 (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 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® Gladiator Plasma Femoral Stems | THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components |
Timeline
- Start date
- 2017-06-16
- Primary completion
- 2027-06-01
- Completion
- 2027-06-01
- First posted
- 2016-07-06
- Last updated
- 2022-07-08
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02823834. Inclusion in this directory is not an endorsement.