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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: CTFEA
* Other: Conventional decision algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic bone disease of femur 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: Ipsilateral previous surgery with or without implants Low quality CT scan or CT does not include at least 2/3 of the femurs. History of fractures, radiation or surgeries in lower limbs. Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to two arms and followed prospectively
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTFEA<br>Decision on preventive surgery vs follow-up will be based on expert judgement, Mirels' score and CTFEA | Diagnostic Test: CTFEA<br>* 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.<br>* Other names: CT-based Finite Element Analysis;|
| Other: Mirels<br>Decision on preventive surgery vs follow-up will be based on expert judgement and Mirels' score | Other: Conventional decision algorithm<br>* Decision on surgery vs follow-up will be based on expert opinion and Mirels' score<br>* Other names: Conventional;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy hypothesis | To compare proportion of patients undergoing surgery in the treatment group vs the control group. | four years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT-based Finite Element Analysis, Randomized Controlled Study, Preventive bone fixation, Randomized Controlled Trial