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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
Implantation of Y-Strut + cementoplasty in the femoral neck
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.
Time frame: 30 days
Target lesion fracture within one month after the implantation
Number of target lesion fracture
Time frame: 30 days
Target lesion fracture within 2 months after the implantation
Number of target lesion fracture
Time frame: 2 months
Non-target femoral fracture within 2 months after the implantation
Number of Non-target femoral fracture
Time frame: 2 months
Non-target femoral fracture within one month after the implantation
Number of Non-target femoral fracture
Time frame: 30 days
Analgesic medication needs (type and dose) within one month after the implantation
Consumption of analgesic medication
Time frame: 30 days
Analgesic medication needs (type and dose) within 2 months after the implantation
Consumption of analgesic medication
Time frame: 2 months
total AE/SAE within one month after the implantation
Number of AE/SAE
Time frame: 30 days
total AE/SAE within 2 months after the implantation
Number of AE/SAE
Time frame: 2 months
AE/SAE imputable to the device (number) within one month after the implantation
Number of AE/SAE imputable to the device
Time frame: 30 days
AE/SAE imputable to the device (number) within 2 months after the implantation
Number of AE/SAE imputable to the device
Time frame: 2 months
AE/SAE imputable to the implatation (number) within one month after the implantation
Number of AE/SAE imputable to the implatation
Time frame: 30 days
AE/SAE imputable to the implatation (number) within 2 months after the implantation
Number of AE/SAE imputable to the implatation
Time frame: 2 months
Morphinic mean dose per day within one month after the implantation
Consumption of morphinic mean dose per day during the month after the procedure
Time frame: 30 days
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
Time frame: 2 months
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.
Time frame: 2 months
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)
Time frame: 2 months
Length of stay within 2 months after the implantation
Length of stay at hospital
Time frame: 2 months
Exit mode of hospital within 2 months after the implantation
at home, re-education unit
Time frame: 2 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.