Evaluation of the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur
- Conditions
- Pathological Fracture of HipBone Metastases
- Registration Number
- NCT03579212
- Lead Sponsor
- Hyprevention
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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.
- Patient who refuse to participate to this study;
- Patient already enrolled in a clinical study, excluding his participation to HIPPON100.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of post-operative fracture [Performance of the device] At 12 months Frequency of patient with a fracture at the implantation site
- Secondary Outcome Measures
Name Time Method Quality of life [Tolerance of the device] pre-operative, immediate post-op, and at 6, 12 and 24 months Assessment of the quality of life using EORTC QLQ-C15-PAL questionnaire: the European Organization for Research and Treatment of Cancer (EORTC) has developed the QLQ-C15-PAL questionnaire (quality of life questionnaire with 15 items), a short version of the QLQ-C30 for palliative (PAL) care. Scale ranges go from 15 (better) to 63 points (worse) at the maximum.
Hospitalisation duration [feasibility of the procedure] At inclusion (day 1) Measuring mean/median hospitalisation duration.
Frequency of post-operative fracture [Performance of the device] At 6 and 24 months Frequency of patient with a fracture at the implantation site
Rates of complications [feasibility of the procedure] At inclusion (day 1) Assessing types and frequencies of procedures complications.
Pain [Tolerance of the device] immediate post-op, and at 6, 12 and 24 months Self-evaluation of pain using VAS (Visual Analogue Scale), going from 0 (no pain) to 10 (maximum).
Surgical procedure duration [feasibility of the procedure] At inclusion (day 1) Measuring mean/median intervention duration.
Resumption of weight-bearing [Tolerance of the device] immediate post-op, and at 6, 12 and 24 months Assessment of resumption of weight-bearing (yes/no at each visit)
Recording of adverse events and device effects [Safety of the device] At 6, 12 and 24 months Recording of the medical device vigilance: all serious adverse events, all adverse events linked to the device or the operative technique, and any other important event reported.
Calculation of associated costs [Economic impact of the procedure] At the end of the study (24 months from the last included patient) Evaluation of each cost associated with all the collected data linked to the procedure (implantation costs, hospitalisation costs, treatments for pain and other events). Then, the different costs are added together to determine the mean total cost of a procedure.
Trial Locations
- Locations (4)
Hopital Tenon - AP-HP
🇫🇷Paris, France
CHU Toulouse
🇫🇷Toulouse, France
CHU Caen
🇫🇷Caen, France
Hôpital européen Georges-Pompidou
🇫🇷Paris, France