Clinical trial NCT03579212: Evaluation of the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pathological Fracture of Hip
Bone Metastases
Keywords: Osteosynthesis
Prophylactic consolidation
Proximal femur
Lead sponsor: Hyprevention
Sponsor class: INDUSTRY
First posted: 2018-07-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with a Y-STRUT® device to strengthen pre-fractural tumour-induced lesions at the level of the proximal femur.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of post-operative fracture [Performance of the device]
timeFrame: At 12 months
Secondary outcomes:
measure: Frequency of post-operative fracture [Performance of the device]
timeFrame: At 6 and 24 months
measure: Pain [Tolerance of the device]
timeFrame: immediate post-op, and at 6, 12 and 24 months
measure: Resumption of weight-bearing [Tolerance of the device]
timeFrame: immediate post-op, and at 6, 12 and 24 months
measure: Quality of life [Tolerance of the device]
timeFrame: pre-operative, immediate post-op, and at 6, 12 and 24 months
measure: Recording of adverse events and device effects [Safety of the device]
timeFrame: At 6, 12 and 24 months
measure: Surgical procedure duration [feasibility of the procedure]
timeFrame: At inclusion (day 1)
measure: Hospitalisation duration [feasibility of the procedure]
timeFrame: At inclusion (day 1)
measure: Rates of complications [feasibility of the procedure]
timeFrame: At inclusion (day 1)
measure: Calculation of associated costs [Economic impact of the procedure]
timeFrame: At the end of the study (24 months from the last included patient)
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen
city: Paris
country: France
facility: Hôpital européen Georges-Pompidou
city: Paris
country: France
facility: Hopital Tenon - AP-HP
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
References: