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

National, Multicentre, Prospective, Observational Study, to Evaluate 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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoporosis; Fracture of Hip
• Intervention / Treatment: Device: Y-STRUT® (Hyprevention, Pessac, France)

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Ambérieu-en-Bugey, France, 01500
    • Hôpital Privé d'Ambérieu
  • Clamart, France, 92140
    • Hôpital Antoine Béclère
  • La Tronche, France, 38700
    • Centre Hospitalier Universitaire Grenoble Alpes
  • Orléans, France, 45100
    • Centre Hospitalier Régional Orléans
  • Tours, France, 37000
    • Nouvelle Clinique de Tours Plus St Gatien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hyprevention

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2017
• Primary Completion (Actual): March 24, 2020
• Study Completion (Actual): March 24, 2020

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Osteosynthesis; Prophylactic consolidation; Proximal femur
• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Leg Injuries; Musculoskeletal Diseases; Bone Diseases; Femoral Fractures; Hip Injuries; Bone Diseases, Metabolic; Fractures, Bone; Hip Fractures; Osteoporosis
• Other Study ID Numbers: HIP50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No