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

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03453905

Collaborator

(none)

162

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Neoplasm of Hip (Diagnosis) Orthopedic Disorder Bone Metastases Proximal Femoral Metaphyseal Abnormality	Diagnostic Test: CTFEA Other: Conventional decision algorithm	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be randomized to two arms and followed prospectivelyPatients will be randomized to two arms and followed prospectively

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2018

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTFEA Decision on preventive surgery vs follow-up will be based on expert judgement, Mirels' score and CTFEA	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 Names: CT-based Finite Element Analysis
Other: Mirels Decision on preventive surgery vs follow-up will be based on expert judgement and Mirels' score	Other: Conventional decision algorithm Decision on surgery vs follow-up will be based on expert opinion and Mirels' score Other Names: Conventional

Arm

Intervention/Treatment

Experimental: CTFEA

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

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 Names:

CT-based Finite Element Analysis

Other: Mirels

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

Other: Conventional decision algorithm

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

Other Names:

Conventional

Outcome Measures

Primary Outcome Measures

Primary efficacy hypothesis [four years]
To compare proportion of patients undergoing surgery in the treatment group vs the control group.

Secondary Outcome Measures

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

Other Outcome Measures

All-cause mortality [4 years]
All-cause mortality
Number of patients who became unable to ambulate [4 years]
Number of patients who became unable to ambulate for any reason. Inability to ambulate will be determined by an orthopedic surgeon from anamnesis and physical examination.
Number of participants who sustained a pathological fracture [4 months]
Number of participants who sustained a pathological fracture. Diagnosis of pathological fracture will be determined by an orthopedic surgeon based on imaging.
Death [30 days]
Death within 30 days after prophylactic surgery
Surgical complications [4 months]
Infection, re-operation, mechanical failure within 4 months of follow up
Number of surgeries avoided [4 months]
The number of surgeries "avoided" - presented only in the group of Intervention and only in patients without the safety endpoint within 4 months of follow up. Specifically, number of patients without the safety endpoint in whom a physician changed his/her decision to operate based on the CT-based FE analysis.
Agreement of two measures of fracture risk [One week]
Agreement between the pathological fracture risk estimated using Mirels' scale and the pathological fracture risk CT-based FE simulation analysis. Risk levels determined by either of the estimates: low, medium, high
Patients who denied surgery [4 months]
Number of patients who did not undergo a prophylactic surgery, in whom the CT-based FE analysis showed a risk above moderate for fractures in future and who developed a fracture during the 4 months of follow-up - calculated in both study groups.
Complications that could be prevented by CTFEA [One month]
Number of patients who underwent a prophylactic surgery, in whom the CT-based FE analysis showed a mild-moderate risk of a fracture and who devel-oped a complication (as defined in a composite safety endpoint) - calculated in both study groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.