An interventional study of CTFEA and Conventional decision algorithm in Bone Neoplasm of Hip (Diagnosis), Orthopedic Disorder and Bone Metastases, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Prevention
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.
752 studies on the registry are indexed under Musculoskeletal Diseases; 164 are open to participants now.
This study's planned enrollment of 162 is above the median of 76 across 518 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 554 studies on the registry; 51 are open to participants now.
Compared within Musculoskeletal Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Decision on preventive surgery vs follow-up will be based on expert judgement, Mirels' score and CTFEA
Diagnostic Test: CTFEA
Decision on preventive surgery vs follow-up will be based on expert judgement and Mirels' score
Other: Conventional decision algorithm
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
Decision on surgery vs follow-up will be based on expert opinion and Mirels' score
Also known as: Conventional
Primary efficacy hypothesis
To compare proportion of patients undergoing surgery in the treatment group vs the control group.
Time frame: four years
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
All-cause mortality
All-cause mortality
Time frame: 4 years
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
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
Death
Death within 30 days after prophylactic surgery
Time frame: 30 days
Surgical complications
Infection, re-operation, mechanical failure within 4 months of follow up
Time frame: 4 months
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
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
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
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
No study locations are listed for this record.
Plan to share: No — The individual participant data will remain in TLVMC and will not be shared
Start is estimated for Mar 2018; primary completion for Mar 2022, 48 months later.
Of 251 non-industry interventional studies with no phase under Musculoskeletal Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 48 months is above that.
Counting every sponsor, half of 266 studies reached it within 16 months; a quarter within 6 and three quarters within 36.
Musculoskeletal Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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