Trials / Terminated
TerminatedNCT03579212
Evaluation of the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur
National, Multicentre, Prospective, Retrospective, Observational Study, to Evaluate the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 16 (actual)
- Sponsor
- Hyprevention · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
HIPPON 100 is a national, multicentre, prospective, retrospective, descriptive and non-interventional study, in patients having a Y-STRUT® medical device implanted to prevent a high risk of impending pathological fracture. The primary objective of this study is to evaluate the performance of the studied medical device by measuring the frequency of patient with a fracture at the implantation site within 1 year after implantation. A total of 100 patients from France will be enrolled (until November 2018) and followed up to 24 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Y-STRUT® (Hyprevention, Pessac, France) | The studied medical device consists of two components implanted in the proximal femur, combined with bone cement. |
Timeline
- Start date
- 2016-11-01
- Primary completion
- 2021-02-28
- Completion
- 2021-02-28
- First posted
- 2018-07-06
- Last updated
- 2021-04-14
Locations
4 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03579212. Inclusion in this directory is not an endorsement.