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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03648775
• Other study ID #: HIP50
• Status: Terminated
• Start date: December 6, 2017
• Est. completion date: March 24, 2020

Study information

• Verified date: April 2020
• Source: Hyprevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 24, 2020
• Est. primary completion date: March 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fracture of Hip
• Fractures, Bone
• Hip Fractures
• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Privé d'Ambérieu	Ambérieu-en-Bugey
France	Hôpital Antoine Béclère	Clamart
France	Centre Hospitalier Universitaire Grenoble Alpes	La Tronche
France	Centre Hospitalier Régional Orléans	Orléans
France	Nouvelle Clinique de Tours Plus St Gatien	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Hyprevention

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Walking conditions [safety and feasibility of the device]	Assessment of resumption of weight-bearing (yes/no, aid)	At 3, 12 and 24 months
Secondary	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
Secondary	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)
Secondary	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)]
Secondary	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)