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

Hip Fractures Clinical Trial

— WAZA-ARY  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03887494
• Other study ID #: K171014J
• Secondary ID: 2018-A01901-54
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 6, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: September 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Olivier Pellerin, MD, PhD
• Phone: +33156092660
• Email: olivier.pellerin[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 30, 2020
• Est. primary completion date: May 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Implantation
Implantation of Y-Strut + cementoplasty in the femoral neck

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Hyprevention

Outcome

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