Evaluation of the Clinical Efficacy of Y-STRUT® Medical Device Implanted for Contralateral Percutaneous Internal Fixation of Proximal Femur, in Patient With a Low Energy Per Trochanteric Fracture on the First Side

Hyprevention

Status: Terminated

Conditions: Osteoporosis; Fracture of Hip

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

Study type: Observational

Funder types: Industry

Identifiers

NCT03648775

HIP50

Details and patient eligibility

About

HIP50 is a national, multicentre, prospective, observational study, in patients presenting a first low energy per trochanteric hip fracture on one side and treated with Y-STRUT® device implanted on the contralateral proximal femur as percutaneous internal fixation to prevent contralateral hip fracture in case of osteoporosis.

The primary objective of this study is to evaluate the clinical efficacy 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 50 patients from France will be enrolled (until December 2020) and followed up to 24 months.

Enrollment: 10 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient of 60 years and older, according to CE indication;
• Patient with information form signed to participate in the study;
• Patients presenting a first low energy hip fracture on one side and having a Y-STRUT® device implanted on the contralateral hip between 0 and 120 days after the treatment of the fracture of the first hip;

Exclusion criteria

• Patient who refuse to participate to this study;
• Patient implanted with Y-STRUT® for another indication;
• Patient already enrolled in a clinical study, excluding his participation to HIP50.