Pathological Fracture of HipNCT03579212
Evaluation of the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur
An observational study of Pathological Fracture of Hip and Bone Metastases, run by Hyprevention at 4 sites in France.
Trial summary
HIPPON 100 is a national, multicentre, prospective, retrospective, descriptive and non-interventional study, in patients having a Y-STRUT® medical device implanted to prevent a high risk of impending pathological fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathological Fracture of Hip, Bone Metastases
- What is being tested?
- Y-STRUT® (Hyprevention, Pessac, France)
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2016to 28 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with a Y-STRUT® device to strengthen pre-fractural tumour-induced lesions at the level of the proximal femur.
Who may be able to join
- Patient ≥ 18 years old
- Patient with information form signed to participate in the study;
- Patient presenting a cancer with bone metastases at the level of the proximal femur and having a Y-STRUT® medical device implanted;
- Patient able to complete a questionnaire.
Who cannot join
- Patient who refuse to participate to this study;
- Patient already enrolled in a clinical study, excluding his participation to HIPPON100.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Caen
Caen, 14033
Hôpital européen Georges-Pompidou
Paris, 75015
Hopital Tenon - AP-HP
Paris, 75020
CHU Toulouse
Toulouse, 31059
About this study
Official title: National, Multicentre, Prospective, Retrospective, Observational Study, to Evaluate the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur
HIPPON 100 is a national, multicentre, prospective, retrospective, descriptive and non-interventional study, in patients having a Y-STRUT® medical device implanted to prevent a high risk of impending pathological fracture.
The primary objective of this study is to evaluate the performance 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 100 patients from France will be enrolled (until November 2018) and followed up to 24 months.
- Conditions
- Pathological Fracture of Hip, Bone Metastases
- Being tested
- Y-STRUT® (Hyprevention, Pessac, France)
- Keywords
- Osteosynthesis, Prophylactic consolidation, Proximal femur
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 [Performance of the device]
Frequency of patient with a fracture at the implantation site
Measured: At 12 months
Secondary outcomes (9)
Frequency of post-operative fracture [Performance of the device]
Frequency of patient with a fracture at the implantation site
Measured: At 6 and 24 months
Pain [Tolerance of the device]
Self-evaluation of pain using VAS (Visual Analogue Scale), going from 0 (no pain) to 10 (maximum).
Measured: immediate post-op, and at 6, 12 and 24 months
Resumption of weight-bearing [Tolerance of the device]
Assessment of resumption of weight-bearing (yes/no at each visit)
Measured: immediate post-op, and at 6, 12 and 24 months
Quality of life [Tolerance of the device]
Assessment of the quality of life using EORTC QLQ-C15-PAL questionnaire: the European Organization for Research and Treatment of Cancer (EORTC) has developed the QLQ-C15-PAL questionnaire (quality of life questionnaire with 15 items), a short version of the QLQ-C30 for palliative (PAL) care. Scale ranges go from 15 (better) to 63 points (worse) at the maximum.
Measured: pre-operative, immediate post-op, and at 6, 12 and 24 months
Recording of adverse events and device effects [Safety 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 6, 12 and 24 months
Surgical procedure duration [feasibility of the procedure]
Measuring mean/median intervention duration.
Measured: At inclusion (day 1)
Hospitalisation duration [feasibility of the procedure]
Measuring mean/median hospitalisation duration.
Measured: At inclusion (day 1)
Rates of complications [feasibility of the procedure]
Assessing types and frequencies of procedures complications.
Measured: At inclusion (day 1)
Calculation of associated costs [Economic impact of the procedure]
Evaluation of each cost associated with all the collected data linked to the procedure (implantation costs, hospitalisation costs, treatments for pain and other events). Then, the different costs are added together to determine the mean total cost of a procedure.
Measured: At the end of the study (24 months from the last included patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study startNov 2016
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Why it stopped: EC withdrawal with termination of the NB contract
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyprevention
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579212
- Sponsor's protocol ID
- HIPPON100
- Status last verified
- Jun 2020
- First submitted
- 22 Sep 2017
- Last updated
- 14 Apr 2021
- 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 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National, Multicentre, Prospective, Retrospective, Observational Study, to Evaluate the Performance of Y-STRUT® Medical Device to Strengthen Pre-fractural Tumour-induced Lesions at the Level of the Proximal Femur
- ClinicalTrials.gov ID
- NCT03579212
- Acronym / sponsor ID
- HIPPON100
- Conditions
- Pathological Fracture of Hip, Bone Metastases
- Keywords
- Osteosynthesis, Prophylactic consolidation, Proximal femur
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: EC withdrawal with termination of the NB contract
- Enrolment
- 16 participants (actual)
- Lead sponsor
- HypreventionIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 6 Jul 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.
HIPPON 100 is a national, multicentre, prospective, retrospective, descriptive and non-interventional study, in patients having a Y-STRUT® medical device implanted to prevent a high risk of impending pathological fracture.
The primary objective of this study is to evaluate the performance 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 100 patients from France will be enrolled (until November 2018) and followed up to 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with a Y-STRUT® device to strengthen pre-fractural tumour-induced lesions at the level of the proximal femur.
Key inclusion criteria (4 listed)
- Patient ≥ 18 years old
- Patient with information form signed to participate in the study;
- Patient presenting a cancer with bone metastases at the level of the proximal femur and having a Y-STRUT® medical device implanted;
- Patient able to complete a questionnaire.
Key exclusion criteria (2 listed)
- Patient who refuse to participate to this study;
- Patient already enrolled in a clinical study, excluding his participation to HIPPON100.
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 [Performance of the device]
Time frame: At 12 months
Frequency of patient with a fracture at the implantation site
9 secondary outcomes
Frequency of post-operative fracture [Performance of the device]
Time frame: At 6 and 24 months
Pain [Tolerance of the device]
Time frame: immediate post-op, and at 6, 12 and 24 months
Resumption of weight-bearing [Tolerance of the device]
Time frame: immediate post-op, and at 6, 12 and 24 months
Quality of life [Tolerance of the device]
Time frame: pre-operative, immediate post-op, and at 6, 12 and 24 months
Recording of adverse events and device effects [Safety of the device]
Time frame: At 6, 12 and 24 months
Surgical procedure duration [feasibility of the procedure]
Time frame: At inclusion (day 1)
Hospitalisation duration [feasibility of the procedure]
Time frame: At inclusion (day 1)
Rates of complications [feasibility of the procedure]
Time frame: At inclusion (day 1)
Calculation of associated costs [Economic impact of the procedure]
Time frame: At the end of the study (24 months from the last included patient)
Results and safety
The study was stopped early (reason given: EC withdrawal with termination of the NB contract). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathological Fracture of Hip and Bone Metastases, run by Hyprevention at 4 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 4 inclusion and 2 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 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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: EC withdrawal with termination of the NB contract). 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 [Performance 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 14 Apr 2021.