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
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
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
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
NCT ID
NCT03453905
First Posted
February 15, 2018
Last Updated
February 26, 2018
Sponsor
Tel-Aviv Sourasky Medical Center
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
background
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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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