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

Browse trials for

• Neoplasm Metastasis 3,508
• Bone Neoplasms 320
• Musculoskeletal Diseases 656

Keywords

• CT-based Finite Element Analysis
• Randomized Controlled Study
• Preventive bone fixation
• Randomized Controlled Trial

Study arms

• Experimental
  CTFEA

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

  Diagnostic Test: CTFEA

• Other
  Mirels

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

  Other: Conventional decision algorithm

Interventions

• Diagnostic testCTFEA

  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.

  Also known as: CT-based Finite Element Analysis

• OtherConventional decision algorithm

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

  Also known as: Conventional

Primary outcomes

1. Primary efficacy hypothesis

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

   Time frame: four years

Secondary outcomes

1. 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

   Time frame: 4 months

Other outcomes

1. All-cause mortality

   All-cause mortality

   Time frame: 4 years

2. 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.

   Time frame: 4 years

3. 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.

   Time frame: 4 months

4. Death

   Death within 30 days after prophylactic surgery

   Time frame: 30 days

5. Surgical complications

   Infection, re-operation, mechanical failure within 4 months of follow up

   Time frame: 4 months

6. 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.

   Time frame: 4 months

7. 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

   Time frame: One week

8. 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.

   Time frame: 4 months

9. 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

   Time frame: One month

Publications

• 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. PubMed 19487532 ↗
• 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. PubMed 2684463 ↗
• 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. PubMed 25761000 ↗
• 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. PubMed 17706228 ↗
• 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. PubMed 21497354 ↗
• 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. PubMed 25284156 ↗
• 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. PubMed 28326347 ↗
• 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. PubMed 25724521 ↗

Individual participant data

Plan to share: No — The individual participant data will remain in TLVMC and will not be shared