Trials / Withdrawn
WithdrawnNCT04615039
Post Market Clinical Follow-Up Study for MicroPort PROFEMUR® Preserve Classic Femoral Stem
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- MicroPort Orthopedics Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PROFEMUR® Preserve Classic Femoral Stem | Single study group of subjects, either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with any type of polyethylene and ceramic acetabular shells, acetabular liners and femoral heads. |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2033-12-01
- Completion
- 2033-12-01
- First posted
- 2020-11-04
- Last updated
- 2021-12-27
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04615039. Inclusion in this directory is not an endorsement.