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

Hyprevention

Status: Terminated

Conditions: Pathological Fracture of Hip; Bone Metastases

Treatments: Device: Y-STRUT® (Hyprevention, Pessac, France)

Study type: Observational

Funder types: Industry

Identifiers

NCT03579212

HIPPON100

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.