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

Not Applicable

• Conditions: Hip Fractures; Pain, Intractable; Neoplasms, Bone Tissue

• Registration Number: NCT03887494
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-25
• Status Verified: 2019-09
• Study Start: 2019-09-06
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-10
• Primary Completion: 2020-05-22
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measure of Quality of Life for each patient within one month after the implantation	30 days	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

Name	Time	Method
Non-target femoral fracture within one month after the implantation	30 days	Number of Non-target femoral fracture
Analgesic medication needs (type and dose) within one month after the implantation	30 days	Consumption of analgesic medication
total AE/SAE within 2 months after the implantation	2 months	Number of AE/SAE
AE/SAE imputable to the implatation (number) within one month after the implantation	30 days	Number of AE/SAE imputable to the implatation
Target lesion fracture within one month after the implantation	30 days	Number of target lesion fracture
Target lesion fracture within 2 months after the implantation	2 months	Number of target lesion fracture
AE/SAE imputable to the device (number) within one month after the implantation	30 days	Number of AE/SAE imputable to the device
AE/SAE imputable to the device (number) within 2 months after the implantation	2 months	Number of AE/SAE imputable to the device
Non-target femoral fracture within 2 months after the implantation	2 months	Number of Non-target femoral fracture
total AE/SAE within one month after the implantation	30 days	Number of AE/SAE
Analgesic medication needs (type and dose) within 2 months after the implantation	2 months	Consumption of analgesic medication
AE/SAE imputable to the implatation (number) within 2 months after the implantation	2 months	Number of AE/SAE imputable to the implatation
Morphinic mean dose per day within one month after the implantation	30 days	Consumption of morphinic mean dose per day during the month after the procedure
Pain score at target site within 2 months after the implantation: VAS	2 months	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	2 months	Length of stay at hospital
Morphinic mean dose per day within 2 months after the implantation	2 months	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	2 months	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.
Exit mode of hospital within 2 months after the implantation	2 months	at home, re-education unit