Neoplasms, Bone TissueWAZA-ARYNCT03887494
Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY)
A study testing Implantation in people with Neoplasms, Bone Tissue and Pain, Intractable, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Bone metastases appear in many cancers. They are associated with severe pain that is refractory to standard treatment. Improving the quality of life and better pain relief is therefore an essential goal of the treatment of metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Bone Tissue, Pain, Intractable, Hip Fractures
- What is being tested?
- Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 6 Sep 2019to 30 Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- age >= 18 years
- patient with a lytic or mixed matrix bone metastasis of the superior femoral epiphysis visualized in imaging
- MIRELS score ≥8 within 20 days prior to inclusion,
- ECOG-PS 2 or 3 within 20 days prior to inclusion,
- Cervico-diaphyseal angle between 115 ° and 135 ° inclusive,
- Length of the proximal part of the femur greater than or equal to 90 mm
- Patient refusing gamma nail
- Life expectancy greater than 6 months
Who cannot join
- Act of general anesthesia impossible,
- ECOG <2 (patients eligible for nailing treatment),
- INR <0.7 in the 24 hours preceding the intervention,
- Platelets <70000 / mm3 within 24 hours of surgery,
- Allergy previously known by the patient to PEEK and / or PMMA,
- Patient who previously had a cementoplasty of the target lesion,
Show all 9Show fewer
- Osteolysis of the target epiphyseal cortex> 2/3 of the circumference of the epiphyseal cortex,
- Pre-fracture lesions of the underlying ipsilateral diaphysis or ipsilateral acetabulum
- Patient unable or unwilling to give written consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Multi-center Study of Impact of Femoral "Y-strut" Implant on Pain and Quality of Life in Patients With Lytic Bone Metastases of the Femoral Neck
Bone metastases appear in many cancers. They are associated with severe pain that is refractory to standard treatment. Improving the quality of life and better pain relief is therefore an essential goal of the treatment of metastatic disease. The most common site of long bone metastases is the superior femoral epiphysis.
The usual management of patients with bone metastases in the superior femoral epiphysis is based on gamma implant osteosynthesis when there is a known risk of fracture (Mirels score> 8). Nonetheless this surgery is only accessible to a few patients because of the associated morbidities.
Read more
Percutaneous cementoplasty has been developed to treat patients who are not eligible for conventional surgery. It consists in a filling of the bone cavity created by metastasis using an acrylic resin. However, these approaches do not completely prevent the risk of upper femoral epiphyseal fracture due to the low mechanical resistance of the resin to shear movements.
The Y-STRUT® implantable medical device was developed to overcome this risk of superior femoral epiphyseal fracture by the biomechanical strengthening of the proximal femur in addition to cementoplasty. It has been successfully tested in more than 70 patients with cancer but access to reimbursement and the APHP market have been postponed due to lack of sufficient clinical evidence.
The investigators propose this prospective phase 2a study in order to provide evidence of the performance of the Y-STRUT® implant.
Read the detailed description
The design consists in a multicenter national open simple arm trial.
All eligible patients with a lytic bone metastases of the superior femoral epiphysis will be included.
The main objective of this study is to describe the impact of the Y-STRUT® implant on the quality of life of patients with lytic bone metastases of the femoral neck by comparing quality of life scores before and one month after the intervention of implantation of the implant.
- Conditions
- Neoplasms, Bone Tissue, Pain, Intractable, Hip Fractures
- Being tested
- Implantation
- Keywords
- Implantable device, Hip fractures
- Medical subject headings
- Neoplasms, Bone Tissue, Pain, Intractable, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantationDevice
Implantation of Y-Strut + cementoplasty in the femoral neck
| Study group | Role | What they receive |
|---|---|---|
| Y-Strut Implant | Experimental | Single interventional arm Receives: Device: Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Quality of Life for each patient within one month after the implantation
Measure of the Quality of Life score using the questionary of quality of life of the European Organization for Research and Treatment of Cancer BM-22.
Patients answer at 22 questions to describe their quality of life during the past week. For each question, patient must choose between 1.not at all, 2.a little, 3.enough, 4.a lot. A global score is calculated by adding the 22 score of each questions. The higher value of this global score represents the better outcome.
Measured: 30 days
Secondary outcomes (18)
Target lesion fracture within one month after the implantation
Number of target lesion fracture
Measured: 30 days
Target lesion fracture within 2 months after the implantation
Number of target lesion fracture
Measured: 2 months
Non-target femoral fracture within 2 months after the implantation
Number of Non-target femoral fracture
Measured: 2 months
Non-target femoral fracture within one month after the implantation
Number of Non-target femoral fracture
Measured: 30 days
Analgesic medication needs (type and dose) within one month after the implantation
Consumption of analgesic medication
Measured: 30 days
Analgesic medication needs (type and dose) within 2 months after the implantation
Consumption of analgesic medication
Measured: 2 months
total AE/SAE within one month after the implantation
Number of AE/SAE
Measured: 30 days
total AE/SAE within 2 months after the implantation
Number of AE/SAE
Measured: 2 months
AE/SAE imputable to the device (number) within one month after the implantation
Number of AE/SAE imputable to the device
Measured: 30 days
AE/SAE imputable to the device (number) within 2 months after the implantation
Number of AE/SAE imputable to the device
Measured: 2 months
AE/SAE imputable to the implatation (number) within one month after the implantation
Number of AE/SAE imputable to the implatation
Measured: 30 days
AE/SAE imputable to the implatation (number) within 2 months after the implantation
Number of AE/SAE imputable to the implatation
Measured: 2 months
Morphinic mean dose per day within one month after the implantation
Consumption of morphinic mean dose per day during the month after the procedure
Measured: 30 days
Morphinic mean dose per day within 2 months after the implantation
Consumption of morphinic mean dose per day during the 2 months after the procedure
Measured: 2 months
Quality of Life score (EORTC QLQ BM-22) within 2 months after the implantation
Measure of the Quality of Life score using the questionary of quality of life of the European Organization for Research and Treatment of Cancer BM-22.
Patients answer at 22 questions to describe their quality of life during the past week. For each question, patient must choose between 1.not at all, 2.a little, 3.enough, 4.a lot. A global score is calculated by adding the 22 score of each questions. The higher value of this global score represents the better outcome.
Measured: 2 months
Pain score at target site within 2 months after the implantation: VAS
Use of Visual Analog Scale (VAS) to evaluate the pain at target site (between 0: no pain to 10: intolerable pain)
Measured: 2 months
Length of stay within 2 months after the implantation
Length of stay at hospital
Measured: 2 months
Exit mode of hospital within 2 months after the implantation
at home, re-education unit
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start6 Sep 2019 (estimated)
- Primary completion22 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, Bone TissueStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Hyprevention
- Responsible party
- Sponsor
- Investigators
- Olivier Pellerin, MD, PhD, Principal investigator, AP-HP, Hôpital Européen Georges Pompidou, ParisFrançois Cornelis, MD, PhD, Principal investigator, AP-HP, Hôpital Tenon, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887494
- Sponsor's protocol ID
- K171014J
- Other IDs
- 2018-A01901-54
- Acronym
- WAZA-ARY
- Status last verified
- Sep 2019
- First submitted
- 21 Mar 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD underlying published results
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-center Study of Impact of Femoral "Y-strut" Implant on Pain and Quality of Life in Patients With Lytic Bone Metastases of the Femoral Neck
- ClinicalTrials.gov ID
- NCT03887494
- Acronym / sponsor ID
- WAZA-ARY / K171014J
- Conditions
- Neoplasms, Bone Tissue, Pain, Intractable, Hip Fractures
- Keywords
- Implantable device, Hip fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Hyprevention
- Study start
- 6 Sep 2019 (estimated)
- Primary completion
- 22 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 25 Mar 2019 (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.
Bone metastases appear in many cancers. They are associated with severe pain that is refractory to standard treatment. Improving the quality of life and better pain relief is therefore an essential goal of the treatment of metastatic disease. The most common site of long bone metastases is the superior femoral epiphysis.
The usual management of patients with bone metastases in the superior femoral epiphysis is based on gamma implant osteosynthesis when there is a known risk of fracture (Mirels score> 8). Nonetheless this surgery is only accessible to a few patients because of the associated morbidities.
Percutaneous cementoplasty has been developed to treat patients who are not eligible for conventional surgery. It consists in a filling of the bone cavity created by metastasis using an acrylic resin. However, these approaches do not completely prevent the risk of upper femoral epiphyseal fracture due to the low mechanical resistance of the resin to shear movements.
The Y-STRUT® implantable medical device was developed to overcome this risk of superior femoral epiphyseal fracture by the biomechanical strengthening of the proximal femur in addition to cementoplasty. It has been successfully tested in more than 70 patients with cancer but access to reimbursement and the APHP market have been postponed due to lack of sufficient clinical evidence.
The investigators propose this prospective phase 2a study in order to provide evidence of the performance of the Y-STRUT® implant.
Detailed description
The design consists in a multicenter national open simple arm trial.
All eligible patients with a lytic bone metastases of the superior femoral epiphysis will be included.
The main objective of this study is to describe the impact of the Y-STRUT® implant on the quality of life of patients with lytic bone metastases of the femoral neck by comparing quality of life scores before and one month after the intervention of implantation of the implant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Y-Strut Implant | Experimental | Device: ImplantationSingle interventional arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age >= 18 years
- patient with a lytic or mixed matrix bone metastasis of the superior femoral epiphysis visualized in imaging
- MIRELS score ≥8 within 20 days prior to inclusion,
- ECOG-PS 2 or 3 within 20 days prior to inclusion,
- Cervico-diaphyseal angle between 115 ° and 135 ° inclusive,
Key exclusion criteria (9 listed)
- Act of general anesthesia impossible,
- ECOG <2 (patients eligible for nailing treatment),
- INR <0.7 in the 24 hours preceding the intervention,
- Platelets <70000 / mm3 within 24 hours of surgery,
- Allergy previously known by the patient to PEEK and / or PMMA,
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 |
|---|---|---|
| ImplantationImplantation of Y-Strut + cementoplasty in the femoral neck | Device | Y-Strut Implant |
Primary outcome
Measure of Quality of Life for each patient within one month after the implantation
Time frame: 30 days
Measure of the Quality of Life score using the questionary of quality of life of the European Organization for Research and Treatment of Cancer BM-22. Patients answer at 22 questions to describe their quality of life during the past week. For each question, patient must choose between 1.not at all, 2.a little, 3.enough, 4.a lot. A global score is calculated by adding the 22 score of each questions. The higher value of this global score represents the better outcome.
18 secondary outcomes
Target lesion fracture within one month after the implantation
Time frame: 30 days
Target lesion fracture within 2 months after the implantation
Time frame: 2 months
Non-target femoral fracture within 2 months after the implantation
Time frame: 2 months
Non-target femoral fracture within one month after the implantation
Time frame: 30 days
Analgesic medication needs (type and dose) within one month after the implantation
Time frame: 30 days
Analgesic medication needs (type and dose) within 2 months after the implantation
Time frame: 2 months
total AE/SAE within one month after the implantation
Time frame: 30 days
total AE/SAE within 2 months after the implantation
Time frame: 2 months
AE/SAE imputable to the device (number) within one month after the implantation
Time frame: 30 days
AE/SAE imputable to the device (number) within 2 months after the implantation
Time frame: 2 months
AE/SAE imputable to the implatation (number) within one month after the implantation
Time frame: 30 days
AE/SAE imputable to the implatation (number) within 2 months after the implantation
Time frame: 2 months
Morphinic mean dose per day within one month after the implantation
Time frame: 30 days
Morphinic mean dose per day within 2 months after the implantation
Time frame: 2 months
Quality of Life score (EORTC QLQ BM-22) within 2 months after the implantation
Time frame: 2 months
Pain score at target site within 2 months after the implantation: VAS
Time frame: 2 months
Length of stay within 2 months after the implantation
Time frame: 2 months
Exit mode of hospital within 2 months after the implantation
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Individual participant dataSharing planned: Yes. IPD underlying published results
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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.
Olivier Pellerin, MD, PhD principal investigator
AP-HP, Hôpital Européen Georges Pompidou, Paris
François Cornelis, MD, PhD principal investigator
AP-HP, Hôpital Tenon, Paris
Questions about this trial
What is this clinical trial studying?
A study testing Implantation in people with Neoplasms, Bone Tissue and Pain, Intractable, run by Assistance Publique - Hôpitaux de Paris.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Pellerin, MD, PhD (+33156092660, olivier.pellerin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of Quality of Life for each patient within one month after the implantation (time frame: 30 days). 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 10 Sep 2019.