Trials / Completed
CompletedNCT01690689
Investigation of a Customized Femoral Resurfacing Implant
Investigation of a Customized Femoral Resurfacing Implant (Episealer® Knee Condyle Device) to Assess the Safety Profile and Performance for 2 Years Post-operatively
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Episurf Medical Inc. · Industry
- Sex
- All
- Age
- 30 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose is to assess the safety profile and performance of a femoral resurfacing implant for localized chondral lesions.
Detailed description
The implant's safety profile will be assessed by incidence of any subject having any of the seven identified implant-related clinical undesirable side effects. This will be analyzed with a one-side exact binomial test on significance level 0.05, at 24 months post-operatively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implant surgery | surgery |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2017-03-31
- Completion
- 2017-03-31
- First posted
- 2012-09-24
- Last updated
- 2020-12-17
Locations
3 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT01690689. Inclusion in this directory is not an endorsement.