Fracture of HipNCT03648775
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
An observational study of Fracture of Hip and Osteoporosis, run by Hyprevention at 5 sites in France.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Fracture of Hip, Osteoporosis
- What is being tested?
- Y-STRUT® (Hyprevention, Pessac, France)
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 5 sitesFrance
- Study dates
- 6 Dec 2017to 24 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Privé d'Ambérieu
Ambérieu-en-Bugey, 01500
Hôpital Antoine Béclère
Clamart, 92140
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, 38700
Centre Hospitalier Régional Orléans
Orléans, 45100
Nouvelle Clinique de Tours Plus St Gatien
Tours, 37000
About this study
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
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
- Being tested
- Y-STRUT® (Hyprevention, Pessac, France)
- Keywords
- Osteosynthesis, Prophylactic consolidation, Proximal femur
- Medical subject headings
- Hip Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-STRUT® (Hyprevention, Pessac, France)Device
The studied medical device consists of two components implanted in the proximal femur, combined with bone cement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of post-operative fracture [Clinical efficacy of the device]
Frequency of Y-STRUT® implanted patients with a fracture at the implantation site
Measured: At 12 months
Secondary outcomes (8)
Frequency of post-operative fracture [Clinical efficacy of the device]
Frequency of Y-STRUT® implanted patients with a fracture at the implantation site
Measured: At 3 and 24 months
Recording of concomitants treatments [safety and feasibility of the device]
Recording of all concomitants treatments: analgesic for pain, anti-osteoporotic treatment and other treatments.
Measured: At 3, 12 and 24 months
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).
Measured: At 3, 12 and 24 months
Walking conditions [safety and feasibility of the device]
Assessment of resumption of weight-bearing (yes/no, aid)
Measured: At 3, 12 and 24 months
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.
Measured: At 3, 12 and 24 months
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.
Measured: At the end of the inclusion period (24 months from the first included patient)
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.
Measured: At the end of the inclusion period (24 months from the first included patient)]
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.
Measured: At the end of the inclusion period (24 months from the first included patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start6 Dec 2017
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Why it stopped: Suspension of the study upon the decision of the notified body
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyprevention
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648775
- Sponsor's protocol ID
- HIP50
- Status last verified
- Apr 2020
- First submitted
- 21 Aug 2018
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03648775
- Acronym / sponsor ID
- HIP50
- Conditions
- Fracture of Hip, Osteoporosis
- Keywords
- Osteosynthesis, Prophylactic consolidation, Proximal femur
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Suspension of the study upon the decision of the notified body
- Enrolment
- 10 participants (actual)
- Lead sponsor
- HypreventionIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Y-STRUT® (Hyprevention, Pessac, France)The studied medical device consists of two components implanted in the proximal femur, combined with bone cement. | Device | – |
Primary outcome
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
8 secondary outcomes
Frequency of post-operative fracture [Clinical efficacy of the device]
Time frame: At 3 and 24 months
Recording of concomitants treatments [safety and feasibility of the device]
Time frame: At 3, 12 and 24 months
Pain [safety and feasibility of the device]
Time frame: At 3, 12 and 24 months
Walking conditions [safety and feasibility of the device]
Time frame: At 3, 12 and 24 months
Recording of adverse events and device effects [safety and feasibility of the device]
Time frame: At 3, 12 and 24 months
Surgical procedure duration [learning curve of the procedure]
Time frame: At the end of the inclusion period (24 months from the first included patient)
Hospitalisation duration [learning curve of the procedure]
Time frame: At the end of the inclusion period (24 months from the first included patient)]
Rate of complications [learning curve of the procedure]
Time frame: At the end of the inclusion period (24 months from the first included patient)
Results and safety
The study was stopped early (reason given: Suspension of the study upon the decision of the notified body). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fracture of Hip and Osteoporosis, run by Hyprevention at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Suspension of the study upon the decision of the notified body). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of post-operative fracture [Clinical efficacy of the device] (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.