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

NCT03579212 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2021-04-14

No results posted yet for this study

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.

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
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2021-02-28
Completion
2021-02-28

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 NCT03579212 on ClinicalTrials.gov