Clinical trial NCT03887494: Study of the Impact of the Femoral Implant "Y-strut" on Lytic Bone Metastases of the Femoral Neck (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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms, Bone Tissue
Pain, Intractable
Hip Fractures
Keywords: Implantable device, Hip fractures
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Hyprevention
First posted: 2019-03-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Measure of Quality of Life for each patient within one month after the implantation
timeFrame: 30 days
Secondary outcomes:
measure: Target lesion fracture within one month after the implantation
timeFrame: 30 days
measure: Target lesion fracture within 2 months after the implantation
timeFrame: 2 months
measure: Non-target femoral fracture within 2 months after the implantation
timeFrame: 2 months
measure: Non-target femoral fracture within one month after the implantation
timeFrame: 30 days
measure: Analgesic medication needs (type and dose) within one month after the implantation
timeFrame: 30 days
measure: Analgesic medication needs (type and dose) within 2 months after the implantation
timeFrame: 2 months
measure: total AE/SAE within one month after the implantation
timeFrame: 30 days
measure: total AE/SAE within 2 months after the implantation
timeFrame: 2 months
measure: AE/SAE imputable to the device (number) within one month after the implantation
timeFrame: 30 days
measure: AE/SAE imputable to the device (number) within 2 months after the implantation
timeFrame: 2 months
measure: AE/SAE imputable to the implatation (number) within one month after the implantation
timeFrame: 30 days
measure: AE/SAE imputable to the implatation (number) within 2 months after the implantation
timeFrame: 2 months
measure: Morphinic mean dose per day within one month after the implantation
timeFrame: 30 days
measure: Morphinic mean dose per day within 2 months after the implantation
timeFrame: 2 months
measure: Quality of Life score (EORTC QLQ BM-22) within 2 months after the implantation
timeFrame: 2 months
measure: Pain score at target site within 2 months after the implantation: VAS
timeFrame: 2 months
measure: Length of stay within 2 months after the implantation
timeFrame: 2 months
measure: Exit mode of hospital within 2 months after the implantation
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: AP-HP, Hôpital Européen Georges Pompidou, Paris
name: Olivier Pellerin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP, Hôpital Tenon, Paris
name: François Cornelis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: