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| Name | Class |
|---|---|
| National Taiwan University Hospital, Yun-Lin Branch | OTHER |
| National Taiwan University Hospital Hsin-Chu Branch | OTHER |
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The goal of this interventional randomized controlled trial is to compare the clinical outcomes in treating extremities pathological fractures (fractures of limbs caused by metastatic tumors) or impending pathological fractures with short or long intramedullary nails. The main questions it aims to answer are:
Participants who meet surgical indication will be randomized into either the long or short intramedullary nail group after informed consent. The patient will receive bone fixation with the corresponding prosthesis.
Participants will be randomized into either long or short intramedullary nail groups. Participants in the long intramedullary nail group will be fixed with a longer intramedullary nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures, while patients in the short intramedullary nail group will be fixed with a shorter intramedullary nail (defined as less than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures. Follow-up will be performed at 1, 3, 6, and 12 months after surgery to analyze the patient's function, blood sampling values, and imaging follow-up. The functional capacity will be evaluated by PROMIS questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short intramedullary nails | Experimental | The patients receives bone fixation with short intramedullary nails for extremity metastases. |
|
| Long intramedullary nails | Active Comparator | The patients receives bone fixation with long intramedullary nails for extremity metastases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internal fixation with short intramedullary nails | Device | Intramedullary nailing is a method of internal fixation used to treat fractures. An intramedullary nail is a metal rod forced into the marrow canal of a bone to stabilize and align fractures. Participants in this group will be fixed with a shorter intramedullary nail (defined as defined as less than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures. |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation rate | Percentage of patients receiving revision surgery within 1 year after the intervention. The primary outcome should be compared using non-inferior tests. The non-inferior margin was pre-specified at 25.4%. | Up to 1 year after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in functional outcome on the Patient-Reported Outcomes Measurement Information System-29 scoring at 1,3,6,12 months after the intervention | The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluates physical, mental, and social health in adults and children. It's used to measure symptoms and other aspects of health status in a wide variety of chronic diseases. PROMIS-29 is a particular version of this system that covers multiple domains of health and function. It consists of 29 items in total, spanning seven domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference. Each domain has four questions, with the exception of the pain interference domain, which has five. Each question is scored from 1-5, the higher score indicates better function or quality of life. The sum of the PROMIS results in the raw score, which lies between 4 and 20. There's also a single question evaluating pain intensity, as assessed by pain intensity numeric rating scale. |
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Inclusion Criteria:
Exclusion Criteria:
The patient has a more appropriate treatment alternative to single intramedullary nail fixation as determined by the multidisciplinary decision, such as,
There are justified, clinically significant rationales that either long or short intramedullary nails be a more appropriate treatment during pre-operative assessment
The patient has imaging-confirmed distant femoral metastases before treatment
Patient has renal cell carcinoma or sarcoma
Patient is unable to cooperate with follow-up or to understand the trial protocol
Patient is unable to communicate in Chinese
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsiang Chieh Hsieh, MD | Contact | +886 972654075 | D08528020@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Hsiang Chieh Hsieh, MD | Department of Orthopaedic Surgery, National Taiwan University Hospital, Hsin-Chu branch | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23104043 | Result | Alvi HM, Damron TA. Prophylactic stabilization for bone metastases, myeloma, or lymphoma: do we need to protect the entire bone? Clin Orthop Relat Res. 2013 Mar;471(3):706-14. doi: 10.1007/s11999-012-2656-1. Epub 2012 Oct 27. |
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|
| Internal fixation with long intramedullary nails | Device | Intramedullary nailing is a method of internal fixation used to treat fractures. An intramedullary nail is a metal rod forced into the marrow canal of a bone to stabilize and align fractures. Participants in this group will be fixed with a longer intramedullary nail (defined as greater than 2/3 of the patient's femur) for proximal femoral (impending) pathological fractures. |
|
| At 1,3,6,12 months after the intervention |
| Cardiopulmonary complication rate within 30 days after the intervention | Cardiopulmonary complication includes the following events developing within 30 days after the intervention: O2 desaturation, shock, embolic event, or coma and death. | Up to 30 days after the intervention |
| Mortality rate at 1,3,6,12 months after the intervention | Percentage of demise at 1,3,6,12 months after the intervention | At 1,3,6,12 months after the intervention |
| Percentage of of participants with distant femoral metastasis | Newly formed metastatic lesions on the same limb distant to the operation site within 1 year after the intervention | Up to 1 year after the intervention |
| Cost-effectiveness analysis | Utility comparison using Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) questionnaire | Up to 2 year after the intervention |
| ID | Term |
|---|---|
| D005598 | Fractures, Spontaneous |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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