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

Tel Aviv Sourasky Medical Center

Status: Unknown

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

Treatments: Diagnostic Test: CTFEA; Other: Conventional decision algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT03453905

0532-17-TLV

Details and patient eligibility

About

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

CTFEA

Experimental group

Description:

Decision on preventive surgery vs follow-up will be based on expert judgement, Mirels' score and CTFEA

Treatment:

Diagnostic Test: CTFEA

Mirels

Other group

Description:

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

Treatment:

Other: Conventional decision algorithm