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

NCT ID: NCT03887494

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-06
• Study Completion Date: 2020-06-30

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.

Conditions

Neoplasms, Bone Tissue; Pain, Intractable; Hip Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Y-Strut Implant

Single interventional arm

Group Type: EXPERIMENTAL

Implantation

Intervention Type: DEVICE

Implantation of Y-Strut + cementoplasty in the femoral neck

Interventions

Implantation

Implantation of Y-Strut + cementoplasty in the femoral neck

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hyprevention

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Pellerin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Hôpital Européen Georges Pompidou, Paris

François Cornelis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Hôpital Tenon, Paris

Central Contacts

Olivier Pellerin, MD, PhD

Role: CONTACT

olivier.pellerin@aphp.fr

+33156092660

Carole Dean, PhD

Role: CONTACT

carole.dean@aphp.fr

+33156093719

Other Identifiers

2018-A01901-54

Identifier Type: OTHER

Identifier Source: secondary_id

K171014J

Identifier Type: -

Identifier Source: org_study_id