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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

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ClinicalTrials.gov Identifier: NCT03648775
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Hyprevention

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 2018) and followed up to 24 months.


Condition or disease Intervention/treatment
Fracture of Hip Osteoporosis Device: Y-STRUT® (Hyprevention, Pessac, France)

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine



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


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


Secondary Outcome Measures :
  1. Frequency of post-operative fracture [Clinical efficacy of the device] [ Time Frame: At 3 and 24 months ]
    Frequency of Y-STRUT® implanted patients with a fracture at the implantation site

  2. Recording of concomitants treatments [safety and feasibility of the device] [ Time Frame: At 3, 12 and 24 months ]
    Recording of all concomitants treatments: analgesic for pain, anti-osteoporotic treatment and other treatments.

  3. Pain [safety and feasibility of the device] [ Time Frame: At 3, 12 and 24 months ]
    Self-evaluation of hip pain using VAS (Visual Analogue Scale), going from 0 (no pain) to 10 (maximum).

  4. Walking conditions [safety and feasibility of the device] [ Time Frame: At 3, 12 and 24 months ]
    Assessment of resumption of weight-bearing (yes/no, aid)

  5. Recording of adverse events and device effects [safety and feasibility of the device] [ Time Frame: At 3, 12 and 24 months ]
    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.

  6. Surgical procedure duration [learning curve of the procedure] [ Time Frame: At the end of the inclusion period (24 months from the first included patient) ]
    Measuring mean/median intervention duration of each procedure. Then, all the durations of successive procedures will be compared among all the investigators.

  7. Hospitalisation duration [learning curve of the procedure] [ Time Frame: At the end of the inclusion period (24 months from the first included patient)] ]
    Measuring mean/median hospitalisation duration. Then, all the durations of successive hospitalisations will be compared among all the investigators.

  8. Rate of complications [learning curve of the procedure] [ Time Frame: At the end of the inclusion period (24 months from the first included patient) ]
    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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648775


Contacts
Contact: Cécile VIENNEY +33557102852 c.vienney@hyprevention.com

Locations
France
Centre Hospitalier Universitaire GRENOBLE ALPES Recruiting
La Tronche, France, 38700
Contact: Jérôme TONETTI, Pr       JTonetti@chu-grenoble.fr   
Nouvelle Clinique de Tours Plus St Gatien Recruiting
Tours, France, 37000
Contact: Damien BABUSIAUX, Dr       damien.babusiaux@gmail.com   
Sponsors and Collaborators
Hyprevention

Responsible Party: Hyprevention
ClinicalTrials.gov Identifier: NCT03648775     History of Changes
Other Study ID Numbers: HIP50
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hyprevention:
Osteosynthesis
Prophylactic consolidation
Proximal femur

Additional relevant MeSH terms:
Hip Fractures
Fractures, Bone
Osteoporosis
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Femoral Fractures
Hip Injuries
Leg Injuries