Study Stopped
Suspension of the study upon the decision of the notified body
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
1 other identifier
observational
10
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2017
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 6, 2017
CompletedFirst Submitted
Initial submission to the registry
August 21, 2018
CompletedFirst Posted
Study publicly available on registry
August 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2020
CompletedApril 29, 2020
April 1, 2020
2.3 years
August 21, 2018
April 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Frequency of post-operative fracture [Clinical efficacy of the device]
At 3 and 24 months
Recording of concomitants treatments [safety and feasibility of the device]
At 3, 12 and 24 months
Pain [safety and feasibility of the device]
At 3, 12 and 24 months
Walking conditions [safety and feasibility of the device]
At 3, 12 and 24 months
Recording of adverse events and device effects [safety and feasibility of the device]
At 3, 12 and 24 months
- +3 more secondary outcomes
Interventions
The studied medical device consists of two components implanted in the proximal femur, combined with bone cement.
Eligibility Criteria
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.
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hypreventionlead
Study Sites (5)
Hôpital Privé d'Ambérieu
Ambérieu-en-Bugey, 01500, France
Hôpital Antoine Béclère
Clamart, 92140, France
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, 38700, France
Centre Hospitalier Régional Orléans
Orléans, 45100, France
Nouvelle Clinique de Tours Plus St Gatien
Tours, 37000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2018
First Posted
August 27, 2018
Study Start
December 6, 2017
Primary Completion
March 24, 2020
Study Completion
March 24, 2020
Last Updated
April 29, 2020
Record last verified: 2020-04