Clinical trial NCT03453905: Evaluation of the Ability of CT-based Finite Element Analysis (CTFEA) to Predict Fractures in Patients With Metastases: a Randomized Controlled Study.
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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-03-05
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to two arms and followed prospectively
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary efficacy hypothesis
timeFrame: four years
Secondary outcomes:
measure: Composite endpoint
timeFrame: 4 months
Other outcomes:
measure: All-cause mortality
timeFrame: 4 years
measure: Number of patients who became unable to ambulate
timeFrame: 4 years
measure: Number of participants who sustained a pathological fracture
timeFrame: 4 months
measure: Death
timeFrame: 30 days
measure: Surgical complications
timeFrame: 4 months
measure: Number of surgeries avoided
timeFrame: 4 months
measure: Agreement of two measures of fracture risk
timeFrame: One week
measure: Patients who denied surgery
timeFrame: 4 months
measure: Complications that could be prevented by CTFEA
timeFrame: One month
Locations:
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Amir Sternheim, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.