MedTrace Logo

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

NCT03648775 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2020-04-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Y-STRUT® (Hyprevention, Pessac, France)

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

Sponsors & Collaborators

  • Hyprevention

    lead INDUSTRY

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-06
Primary Completion
2020-03-24
Completion
2020-03-24

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03648775 on ClinicalTrials.gov