NCT03453905

Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Patients with metastases to proximal femur, who are evaluated fr the risk of pathologic fracture in order to decide on preventive fixation vs follow-up constitute the study population. The patients will be randomized in two arms. First arm - the decision of treatment will rely on conventional decision algorithm including specialist judgement and Mirels' score. Second arm- the decision on treatment will be supported by CTFEA analysis of bone structure and quantitative simulation-based estimate of fracture risk, in addition to the conventional decision algorithm. Operation rates, pathologic fracture rates and additional secondary outcomes will be compared between the two study arms.

Conditions

• Bone Neoplasm of Hip (Diagnosis)
• Orthopedic Disorder
• Bone Metastases
• Proximal Femoral Metaphyseal Abnormality

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CTFEA	CT scans are used to generate a finite element model of patient-specific long bones. The bone model is loaded in stance position. Load based on patient's weight and the mechanical response, including the risk of fracture, is computed.
OTHER	Conventional decision algorithm	Decision on surgery vs follow-up will be based on expert opinion and Mirels' score

Timeline

• Start date: 2018-03-01
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2018-03-05
• Last updated: 2018-03-05