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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-06

Study Completion Date

2020-03-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Fracture of Hip Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Y-STRUT® (Hyprevention, Pessac, France)

The studied medical device consists of two components implanted in the proximal femur, combined with bone cement.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No