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

Bone Metastases Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03453905
• Other study ID #: 0532-17-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: February 15, 2018
• Last updated: February 26, 2018
• Start date: March 1, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2018
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Haggai Schermann, MD
• Phone: 0528771014
• Email: sheralmi[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Metastases
• Bone Neoplasm of Hip (Diagnosis)
• Bone Neoplasms
• Musculoskeletal Diseases
• Neoplasm Metastasis
• Orthopedic Disorder
• Proximal Femoral Metaphyseal Abnormality

Intervention

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:
• Conventional decision algorithm
Decision on surgery vs follow-up will be based on expert opinion and Mirels' score

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

References & Publications (8)

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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2007 Aug 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-cause mortality	All-cause mortality	4 years
Other	Number of patients who became unable to ambulate	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.	4 years
Other	Number of participants who sustained a pathological fracture	Number of participants who sustained a pathological fracture. Diagnosis of pathological fracture will be determined by an orthopedic surgeon based on imaging.	4 months
Other	Death	Death within 30 days after prophylactic surgery	30 days
Other	Surgical complications	Infection, re-operation, mechanical failure within 4 months of follow up	4 months
Other	Number of surgeries avoided	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.	4 months
Other	Agreement of two measures of fracture risk	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	One week
Other	Patients who denied surgery	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.	4 months
Other	Complications that could be prevented by CTFEA	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	One month
Primary	Primary efficacy hypothesis	To compare proportion of patients undergoing surgery in the treatment group vs the control group.	four years
Secondary	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	4 months