Clinical trial NCT03648775: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fracture of Hip
Osteoporosis
Keywords: Osteosynthesis
Prophylactic consolidation
Proximal femur
Lead sponsor: Hyprevention
Sponsor class: INDUSTRY
First posted: 2018-08-27
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of post-operative fracture [Clinical efficacy of the device]
timeFrame: At 12 months
Secondary outcomes:
measure: Frequency of post-operative fracture [Clinical efficacy of the device]
timeFrame: At 3 and 24 months
measure: Recording of concomitants treatments [safety and feasibility of the device]
timeFrame: At 3, 12 and 24 months
measure: Pain [safety and feasibility of the device]
timeFrame: At 3, 12 and 24 months
measure: Walking conditions [safety and feasibility of the device]
timeFrame: At 3, 12 and 24 months
measure: Recording of adverse events and device effects [safety and feasibility of the device]
timeFrame: At 3, 12 and 24 months
measure: Surgical procedure duration [learning curve of the procedure]
timeFrame: At the end of the inclusion period (24 months from the first included patient)
measure: Hospitalisation duration [learning curve of the procedure]
timeFrame: At the end of the inclusion period (24 months from the first included patient)]
measure: Rate of complications [learning curve of the procedure]
timeFrame: At the end of the inclusion period (24 months from the first included patient)
Other outcomes:
Locations:
city: Ambérieu-en-Bugey
country: France
facility: Hôpital Privé d'Ambérieu
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
city: Orléans
country: France
facility: Centre Hospitalier Régional Orléans
city: Tours
country: France
facility: Nouvelle Clinique de Tours Plus St Gatien
Study officials:
References: