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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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neoplasms, Bone Tissue focused on measuring Implantable device, Hip fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 21, 2019
    Last Updated
    September 9, 2019
    Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    Hyprevention
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    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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