Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): EC withdrawal with termination of the NB contract
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Pathological Fracture of Hip | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Y-STRUT® (Hyprevention, Pessac, France) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Frequency of post-operative fracture [Performance of the device]
- timeFrame
- At 12 months
- description
- Frequency of patient with a fracture at the implantation site
Secondary outcomes (9)
- measure
- Frequency of post-operative fracture [Performance of the device]
- timeFrame
- At 6 and 24 months
- description
- Frequency of patient with a fracture at the implantation site
- measure
- Pain [Tolerance of the device]
- timeFrame
- immediate post-op, and at 6, 12 and 24 months
- description
- Self-evaluation of pain using VAS (Visual Analogue Scale), going from 0 (no pain) to 10 (maximum).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient ≥ 18 years old * Patient with information form signed to participate in the study; * Patient presenting a cancer with bone metastases at the level of the proximal femur and having a Y-STRUT® medical device implanted; * Patient able to complete a questionnaire. Exclusion Criteria: * Patient who refuse to participate to this study; * Patient already enrolled in a clinical study, excluding his participation to HIPPON100.
References
Publications (0)
Data not yet available