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

Not Applicable

• Conditions: Bone Neoplasm of Hip (Diagnosis); Orthopedic Disorder; Bone Metastases; Proximal Femoral Metaphyseal Abnormality
• Interventions: Other: Conventional decision algorithm; Diagnostic Test: CTFEA

• Registration Number: NCT03453905
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-02-26
• Last Update Submitted: 2018-02-26
• Study Start: 2018-03-01
• Study First Posted: 2018-03-05
• Last Update Posted: 2018-03-05
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirels	Conventional decision algorithm	Decision on preventive surgery vs follow-up will be based on expert judgement and Mirels' score
CTFEA	CTFEA	Decision on preventive surgery vs follow-up will be based on expert judgement, Mirels' score and CTFEA

Primary Outcome Measures

Name	Time	Method
Primary efficacy hypothesis	four years	To compare proportion of patients undergoing surgery in the treatment group vs the control group.

Secondary Outcome Measures

Name	Time	Method
Composite endpoint	4 months	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