TerminatedNot Applicable

Evaluation of the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur

Stopped: EC withdrawal with termination of the NB contract

France16 participantsStarted 2016-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Frequency of post-operative fracture [Performance of the device]

Timeframe: At 12 months

Trial details

NCT IDNCT03579212

SponsorHyprevention

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-02-28

View on ClinicalTrials.gov More Pathological Fracture of Hip trials