Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (WAZA-ARY) (WAZA-ARY)

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.

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.

Study Overview

• Status: Unknown
• Conditions: Neoplasms, Bone Tissue; Hip Fractures; Pain, Intractable
• Intervention / Treatment: Device: Implantation

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier Pellerin, MD, PhD; Phone Number: +33156092660; Email: olivier.pellerin@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Y-Strut Implant; Single interventional arm	Device: Implantation; Implantation of Y-Strut + cementoplasty in the femoral neck

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion fracture within one month after the implantation	Number of target lesion fracture	30 days
Target lesion fracture within 2 months after the implantation	Number of target lesion fracture	2 months
Non-target femoral fracture within 2 months after the implantation	Number of Non-target femoral fracture	2 months
Non-target femoral fracture within one month after the implantation	Number of Non-target femoral fracture	30 days
Analgesic medication needs (type and dose) within one month after the implantation	Consumption of analgesic medication	30 days
Analgesic medication needs (type and dose) within 2 months after the implantation	Consumption of analgesic medication	2 months
total AE/SAE within one month after the implantation	Number of AE/SAE	30 days
total AE/SAE within 2 months after the implantation	Number of AE/SAE	2 months
AE/SAE imputable to the device (number) within one month after the implantation	Number of AE/SAE imputable to the device	30 days
AE/SAE imputable to the device (number) within 2 months after the implantation	Number of AE/SAE imputable to the device	2 months
AE/SAE imputable to the implatation (number) within one month after the implantation	Number of AE/SAE imputable to the implatation	30 days
AE/SAE imputable to the implatation (number) within 2 months after the implantation	Number of AE/SAE imputable to the implatation	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	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	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.	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)	2 months
Length of stay within 2 months after the implantation	Length of stay at hospital	2 months
Exit mode of hospital within 2 months after the implantation	at home, re-education unit	2 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Hyprevention
• Investigators: Principal Investigator: Olivier Pellerin, MD, PhD, AP-HP, Hôpital Européen Georges Pompidou, Paris; Principal Investigator: François Cornelis, MD, PhD, AP-HP, Hôpital Tenon, Paris

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 6, 2019
• Primary Completion (ANTICIPATED): May 22, 2020
• Study Completion (ANTICIPATED): June 30, 2020

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (ACTUAL): March 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Implantable device, Hip fractures
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Leg Injuries; Musculoskeletal Diseases; Bone Diseases; Neoplasms, Connective Tissue; Femoral Fractures; Hip Injuries; Bone Neoplasms; Hip Fractures; Pain, Intractable; Neoplasms, Bone Tissue
• Other Study ID Numbers: K171014J; 2018-A01901-54 (OTHER: Eudract Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No