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

NCT03887494 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-09-10

No results posted yet for this study

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.

Conditions

  • Neoplasms, Bone Tissue
  • Pain, Intractable
  • Hip Fractures

Interventions

DEVICE

Implantation

Implantation of Y-Strut + cementoplasty in the femoral neck

Sponsors & Collaborators

  • Hyprevention

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Olivier Pellerin, MD, PhD · AP-HP, Hôpital Européen Georges Pompidou, Paris

  • François Cornelis, MD, PhD · AP-HP, Hôpital Tenon, Paris

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-06
Primary Completion
2020-05-22
Completion
2020-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03887494 on ClinicalTrials.gov