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

NCT03887494 | Unknown

• 2 other identifiers: K171014J2018-A01901-54
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neoplasms, Bone Tissue; Pain, Intractable; Hip Fractures

Keywords

Implantable device, Hip fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Target lesion fracture within one month after the implantation

  30 days

• Target lesion fracture within 2 months after the implantation

  2 months

• Non-target femoral fracture within 2 months after the implantation

  2 months

• Non-target femoral fracture within one month after the implantation

  30 days

• Analgesic medication needs (type and dose) within one month after the implantation

  30 days

Study Arms (1)

Y-Strut Implant

EXPERIMENTAL

Single interventional arm

Device: Implantation

Interventions

Implantation DEVICE

Implantation of Y-Strut + cementoplasty in the femoral neck

Y-Strut Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>= 18 years
• patient with a lytic or mixed matrix bone metastasis of the superior femoral epiphysis visualized in imaging
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Hyprevention: collaborator

MeSH Terms

Conditions

Neoplasms, Bone Tissue; Pain, Intractable; Hip Fractures

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Olivier Pellerin, MD, PhD

  AP-HP, Hôpital Européen Georges Pompidou, Paris

  PRINCIPAL INVESTIGATOR

• François Cornelis, MD, PhD

  AP-HP, Hôpital Tenon, Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Pellerin, MD, PhD

CONTACT

+33156092660; olivier.pellerin@aphp.fr

Carole Dean, PhD

CONTACT

+33156093719; carole.dean@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 25, 2019
• Study Start: September 6, 2019
• Primary Completion: May 22, 2020
• Study Completion: June 30, 2020
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: One year after the last publication
• 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.