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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 22, 2019

Keywords

ClinConnect Summary

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.

Gender

ALL

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.