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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. (ZYCTFEA)

Primary Purpose

Bone Neoplasm of Hip (Diagnosis), Orthopedic Disorder, Bone Metastases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CTFEA
Conventional decision algorithm
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Neoplasm of Hip (Diagnosis) focused on measuring CT-based Finite Element Analysis, Randomized Controlled Study, Preventive bone fixation, Randomized Controlled Trial

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    CTFEA

    Mirels

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    February 15, 2018
    Last Updated
    February 26, 2018
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03453905
    Brief Title
    Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.
    Acronym
    ZYCTFEA
    Official Title
    Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2018 (Anticipated)
    Primary Completion Date
    March 1, 2022 (Anticipated)
    Study Completion Date
    March 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Neoplasm of Hip (Diagnosis), Orthopedic Disorder, Bone Metastases, Proximal Femoral Metaphyseal Abnormality
    Keywords
    CT-based Finite Element Analysis, Randomized Controlled Study, Preventive bone fixation, Randomized Controlled Trial

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be randomized to two arms and followed prospectively
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    162 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CTFEA
    Arm Type
    Experimental
    Arm Description
    Decision on preventive surgery vs follow-up will be based on expert judgement, Mirels' score and CTFEA
    Arm Title
    Mirels
    Arm Type
    Other
    Arm Description
    Decision on preventive surgery vs follow-up will be based on expert judgement and Mirels' score
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    CTFEA
    Other Intervention Name(s)
    CT-based Finite Element Analysis
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional decision algorithm
    Other Intervention Name(s)
    Conventional
    Intervention Description
    Decision on surgery vs follow-up will be based on expert opinion and Mirels' score
    Primary Outcome Measure Information:
    Title
    Primary efficacy hypothesis
    Description
    To compare proportion of patients undergoing surgery in the treatment group vs the control group.
    Time Frame
    four years
    Secondary Outcome Measure Information:
    Title
    Composite endpoint
    Description
    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
    Other Pre-specified Outcome Measures:
    Title
    All-cause mortality
    Description
    All-cause mortality
    Time Frame
    4 years
    Title
    Number of patients who became unable to ambulate
    Description
    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.
    Time Frame
    4 years
    Title
    Number of participants who sustained a pathological fracture
    Description
    Number of participants who sustained a pathological fracture. Diagnosis of pathological fracture will be determined by an orthopedic surgeon based on imaging.
    Time Frame
    4 months
    Title
    Death
    Description
    Death within 30 days after prophylactic surgery
    Time Frame
    30 days
    Title
    Surgical complications
    Description
    Infection, re-operation, mechanical failure within 4 months of follow up
    Time Frame
    4 months
    Title
    Number of surgeries avoided
    Description
    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.
    Time Frame
    4 months
    Title
    Agreement of two measures of fracture risk
    Description
    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
    Time Frame
    One week
    Title
    Patients who denied surgery
    Description
    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.
    Time Frame
    4 months
    Title
    Complications that could be prevented by CTFEA
    Description
    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
    Time Frame
    One month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Haggai Schermann, MD
    Phone
    0528771014
    Ext
    +972
    Email
    sheralmi@bu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amir Sternheim, MD
    Email
    amirst@tlvmc.gov.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amir Sternheim, MD
    Organizational Affiliation
    Tel-Aviv Sourasky Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The individual participant data will remain in TLVMC and will not be shared
    Citations:
    PubMed Identifier
    19487532
    Citation
    Bickels J, Dadia S, Lidar Z. Surgical management of metastatic bone disease. J Bone Joint Surg Am. 2009 Jun;91(6):1503-16. doi: 10.2106/JBJS.H.00175.
    Results Reference
    background
    PubMed Identifier
    2684463
    Citation
    Mirels H. Metastatic disease in long bones. A proposed scoring system for diagnosing impending pathologic fractures. Clin Orthop Relat Res. 1989 Dec;(249):256-64.
    Results Reference
    background
    PubMed Identifier
    25761000
    Citation
    Goodheart JR, Cleary RJ, Damron TA, Mann KA. Simulating activities of daily living with finite element analysis improves fracture prediction for patients with metastatic femoral lesions. J Orthop Res. 2015 Aug;33(8):1226-34. doi: 10.1002/jor.22887. Epub 2015 May 21.
    Results Reference
    background
    PubMed Identifier
    17706228
    Citation
    Yosibash Z, Trabelsi N, Milgrom C. Reliable simulations of the human proximal femur by high-order finite element analysis validated by experimental observations. J Biomech. 2007;40(16):3688-99. doi: 10.1016/j.jbiomech.2007.06.017. Epub 2007 Aug 13.
    Results Reference
    background
    PubMed Identifier
    21497354
    Citation
    Trabelsi N, Yosibash Z, Wutte C, Augat P, Eberle S. Patient-specific finite element analysis of the human femur--a double-blinded biomechanical validation. J Biomech. 2011 Jun 3;44(9):1666-72. doi: 10.1016/j.jbiomech.2011.03.024. Epub 2011 Apr 15. Erratum In: J Biomech. 2012 Feb 23;45(4):724-5.
    Results Reference
    background
    PubMed Identifier
    25284156
    Citation
    Yosibash Z, Plitman Mayo R, Dahan G, Trabelsi N, Amir G, Milgrom C. Predicting the stiffness and strength of human femurs with real metastatic tumors. Bone. 2014 Dec;69:180-90. doi: 10.1016/j.bone.2014.09.022. Epub 2014 Oct 2.
    Results Reference
    background
    PubMed Identifier
    28326347
    Citation
    Benca E, Patsch JM, Mayr W, Pahr DH, Windhager R. The insufficiencies of risk analysis of impending pathological fractures in patients with femoral metastases: A literature review. Bone Rep. 2016 Mar 2;5:51-56. doi: 10.1016/j.bonr.2016.02.003. eCollection 2016 Dec.
    Results Reference
    background
    PubMed Identifier
    25724521
    Citation
    Nazarian A, Entezari V, Zurakowski D, Calderon N, Hipp JA, Villa-Camacho JC, Lin PP, Cheung FH, Aboulafia AJ, Turcotte R, Anderson ME, Gebhardt MC, Cheng EY, Terek RM, Yaszemski M, Damron TA, Snyder BD. Treatment Planning and Fracture Prediction in Patients with Skeletal Metastasis with CT-Based Rigidity Analysis. Clin Cancer Res. 2015 Jun 1;21(11):2514-9. doi: 10.1158/1078-0432.CCR-14-2668. Epub 2015 Feb 27.
    Results Reference
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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.

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