Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY) (WAZA-ARY)
Primary Purpose
Neoplasms, Bone Tissue, Pain, Intractable, Hip Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implantation
Sponsored by
About this trial
This is an interventional supportive care trial for Neoplasms, Bone Tissue focused on measuring Implantable device, Hip fractures
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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,
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Y-Strut Implant
Arm Description
Single interventional arm
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Target lesion fracture within one month after the implantation
Number of target lesion fracture
Target lesion fracture within 2 months after the implantation
Number of target lesion fracture
Non-target femoral fracture within 2 months after the implantation
Number of Non-target femoral fracture
Non-target femoral fracture within one month after the implantation
Number of Non-target femoral fracture
Analgesic medication needs (type and dose) within one month after the implantation
Consumption of analgesic medication
Analgesic medication needs (type and dose) within 2 months after the implantation
Consumption of analgesic medication
total AE/SAE within one month after the implantation
Number of AE/SAE
total AE/SAE within 2 months after the implantation
Number of AE/SAE
AE/SAE imputable to the device (number) within one month after the implantation
Number of AE/SAE imputable to the device
AE/SAE imputable to the device (number) within 2 months after the implantation
Number of AE/SAE imputable to the device
AE/SAE imputable to the implatation (number) within one month after the implantation
Number of AE/SAE imputable to the implatation
AE/SAE imputable to the implatation (number) within 2 months after the implantation
Number of AE/SAE imputable to the implatation
Morphinic mean dose per day within one month after the implantation
Consumption of morphinic mean dose per day during the month after the procedure
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
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.
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)
Length of stay within 2 months after the implantation
Length of stay at hospital
Exit mode of hospital within 2 months after the implantation
at home, re-education unit
Full Information
NCT ID
NCT03887494
First Posted
March 21, 2019
Last Updated
September 9, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Hyprevention
1. Study Identification
Unique Protocol Identification Number
NCT03887494
Brief Title
Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY)
Acronym
WAZA-ARY
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 6, 2019 (Anticipated)
Primary Completion Date
May 22, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Hyprevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Bone Tissue, Pain, Intractable, Hip Fractures
Keywords
Implantable device, Hip fractures
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Y-Strut Implant
Arm Type
Experimental
Arm Description
Single interventional arm
Intervention Type
Device
Intervention Name(s)
Implantation
Intervention Description
Implantation of Y-Strut + cementoplasty in the femoral neck
Primary Outcome Measure Information:
Title
Measure of Quality of Life for each patient within one month after the implantation
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Target lesion fracture within one month after the implantation
Description
Number of target lesion fracture
Time Frame
30 days
Title
Target lesion fracture within 2 months after the implantation
Description
Number of target lesion fracture
Time Frame
2 months
Title
Non-target femoral fracture within 2 months after the implantation
Description
Number of Non-target femoral fracture
Time Frame
2 months
Title
Non-target femoral fracture within one month after the implantation
Description
Number of Non-target femoral fracture
Time Frame
30 days
Title
Analgesic medication needs (type and dose) within one month after the implantation
Description
Consumption of analgesic medication
Time Frame
30 days
Title
Analgesic medication needs (type and dose) within 2 months after the implantation
Description
Consumption of analgesic medication
Time Frame
2 months
Title
total AE/SAE within one month after the implantation
Description
Number of AE/SAE
Time Frame
30 days
Title
total AE/SAE within 2 months after the implantation
Description
Number of AE/SAE
Time Frame
2 months
Title
AE/SAE imputable to the device (number) within one month after the implantation
Description
Number of AE/SAE imputable to the device
Time Frame
30 days
Title
AE/SAE imputable to the device (number) within 2 months after the implantation
Description
Number of AE/SAE imputable to the device
Time Frame
2 months
Title
AE/SAE imputable to the implatation (number) within one month after the implantation
Description
Number of AE/SAE imputable to the implatation
Time Frame
30 days
Title
AE/SAE imputable to the implatation (number) within 2 months after the implantation
Description
Number of AE/SAE imputable to the implatation
Time Frame
2 months
Title
Morphinic mean dose per day within one month after the implantation
Description
Consumption of morphinic mean dose per day during the month after the procedure
Time Frame
30 days
Title
Morphinic mean dose per day within 2 months after the implantation
Description
Consumption of morphinic mean dose per day during the 2 months after the procedure
Time Frame
2 months
Title
Quality of Life score (EORTC QLQ BM-22) within 2 months after the implantation
Description
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.
Time Frame
2 months
Title
Pain score at target site within 2 months after the implantation: VAS
Description
Use of Visual Analog Scale (VAS) to evaluate the pain at target site (between 0: no pain to 10: intolerable pain)
Time Frame
2 months
Title
Length of stay within 2 months after the implantation
Description
Length of stay at hospital
Time Frame
2 months
Title
Exit mode of hospital within 2 months after the implantation
Description
at home, re-education unit
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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,
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Pellerin, MD, PhD
Phone
+33156092660
Email
olivier.pellerin@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Carole Dean, PhD
Phone
+33156093719
Email
carole.dean@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Pellerin, MD, PhD
Organizational Affiliation
AP-HP, Hôpital Européen Georges Pompidou, Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François Cornelis, MD, PhD
Organizational Affiliation
AP-HP, Hôpital Tenon, Paris
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD underlying published results
IPD Sharing Time Frame
One year after the last publication
IPD Sharing Access Criteria
Data sharing must be accepted by the sponsor and the PI based on scientific project and scientific involvement of the PI team.
Teams wishing obtain IPD must meet the sponsor and IP team to present scientifical (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Tecnical faisability and financial support will be discussed before mandatory contractualization.
Learn more about this trial
Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY)
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