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

Terminated

• Conditions: Fracture of Hip; Osteoporosis

• Registration Number: NCT03648775
• Lead Sponsor: Hyprevention

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-06
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Primary Completion: 2020-03-24
• Study Completion: 2020-03-24
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of post-operative fracture [Clinical efficacy of the device]	At 12 months	Frequency of Y-STRUT® implanted patients with a fracture at the implantation site

Secondary Outcome Measures

Name	Time	Method
Pain [safety and feasibility of the device]	At 3, 12 and 24 months	Self-evaluation of hip pain using VAS (Visual Analogue Scale), going from 0 (no pain) to 10 (maximum).
Recording of adverse events and device effects [safety and feasibility of the device]	At 3, 12 and 24 months	Recording of the medical device vigilance: all serious adverse events, all adverse events linked to the device or the operative technique, and any other important event reported.
Frequency of post-operative fracture [Clinical efficacy of the device]	At 3 and 24 months	Frequency of Y-STRUT® implanted patients with a fracture at the implantation site
Surgical procedure duration [learning curve of the procedure]	At the end of the inclusion period (24 months from the first included patient)	Measuring mean/median intervention duration of each procedure. Then, all the durations of successive procedures will be compared among all the investigators.
Rate of complications [learning curve of the procedure]	At the end of the inclusion period (24 months from the first included patient)	Assessing types and frequencies of procedures complications (per-op and post-op). Then, all the rate of complications will be compared among all the investigators.
Recording of concomitants treatments [safety and feasibility of the device]	At 3, 12 and 24 months	Recording of all concomitants treatments: analgesic for pain, anti-osteoporotic treatment and other treatments.
Walking conditions [safety and feasibility of the device]	At 3, 12 and 24 months	Assessment of resumption of weight-bearing (yes/no, aid)
Hospitalisation duration [learning curve of the procedure]	At the end of the inclusion period (24 months from the first included patient)]	Measuring mean/median hospitalisation duration. Then, all the durations of successive hospitalisations will be compared among all the investigators.

Trial Locations

Locations (5)

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

Hôpital Privé d'Ambérieu; 🇫🇷 Ambérieu-en-Bugey, France

Centre Hospitalier Universitaire Grenoble Alpes; 🇫🇷 La Tronche, France

Centre Hospitalier Régional Orléans; 🇫🇷 Orléans, France

Nouvelle Clinique de Tours Plus St Gatien; 🇫🇷 Tours, France