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

Tel-Aviv Sourasky Medical Center162 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

162

Conditions

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

Interventions

CTFEADIAGNOSTIC_TEST

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.

Conventional decision algorithmOTHER

Decision on surgery vs follow-up will be based on expert opinion and Mirels' score

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Metastatic bone disease of femur 2. Patients who undergo a CT scan (soft tissue kernel/filter, 120 kVp), and have at least 2/3 of both femurs visible in the CT scan. If CT scan is performed at the Sourasky medical center it must be according to the protocol in Appendix A. Exclusion Criteria: 1. Ipsilateral previous surgery with or without implants 2. Low quality CT scan or CT does not include at least 2/3 of the femurs. 3. History of fractures, radiation or surgeries in lower limbs. 4. Inability to provide informed consent

Outcomes

Primary Outcomes

Primary efficacy hypothesis

To compare proportion of patients undergoing surgery in the treatment group vs the control group.

Time frame: four years

Secondary Outcomes

Composite endpoint

pathological fracture during 4 months of follow up OR death within 30 days after prophylactic surgery in patients who underwent surgery OR surgical complications within 4 months of follow up: infection, re-operation, mechanical failure

Time frame: 4 months