Bone Metastases, Bone Neoplasm of Hip (Diagnosis), Orthopedic Disorder, Proximal Femoral Metaphyseal Abnormality
Conditions
Keywords
CT-based Finite Element Analysis, Randomized Controlled Study, Preventive bone fixation, Randomized Controlled Trial
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.
Interventions
OTHERConventional decision algorithm
Decision on surgery vs follow-up will be based on expert opinion and Mirels' score
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.
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients will be randomized to two arms and followed prospectively
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary efficacy hypothesis | four years | To compare proportion of patients undergoing surgery in the treatment group vs the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint | 4 months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who became unable to ambulate | 4 years | 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. |
| Number of participants who sustained a pathological fracture | 4 months | Number of participants who sustained a pathological fracture. Diagnosis of pathological fracture will be determined by an orthopedic surgeon based on imaging. |
| Death | 30 days | Death within 30 days after prophylactic surgery |
| Surgical complications | 4 months | Infection, re-operation, mechanical failure within 4 months of follow up |
| Number of surgeries avoided | 4 months | 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. |
| Agreement of two measures of fracture risk | One week | 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 |
| Patients who denied surgery | 4 months | 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. |
| Complications that could be prevented by CTFEA | One month | 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 |
| All-cause mortality | 4 years | All-cause mortality |
Contacts
Primary ContactHaggai Schermann, MD
Backup ContactAmir Sternheim, MD
Outcome results
None listed