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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Hyprevention · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fracture of Hip
• Osteoporosis

Interventions

Type	Name	Description
DEVICE	Y-STRUT® (Hyprevention, Pessac, France)	The studied medical device consists of two components implanted in the proximal femur, combined with bone cement.

Timeline

• Start date: 2017-12-06
• Primary completion: 2020-03-24
• Completion: 2020-03-24
• First posted: 2018-08-27
• Last updated: 2020-04-29

Locations

5 sites across 1 country: France