Metastatic Pathologic Fractures, Short Term Results

Study Overview
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Brief Summary
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This is a single center prospective study to compare the short term results of prosthesis, nail and plate-screw surgeries for metastatic pathologic fractures.

Detailed Description
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The most common bone tumor in elderly is metastatic bone tumors. With the prolonged life expectancy in cancer patients, the management of the metastases became an essential topic. Pathological fractures should be examined and managed with a different perspective. They usually cannot be healed by conservative methods and require surgical intervention. The primary goals of surgical intervention are to relieve pain and mobilize the patient as soon as possible. The aim of the study is to compare the short-term functional endoprosthetic recontruction, intramedullary nailing and open reduction internal fixation. The primary tumor of the patient, applied chemotherapy and radiotherapy, Mirel risk score, Charlson comorbidity index, and PathFx 3.0 survival will be evaluated preoperatively. The type of the operation will be decided at the multidisciplinary tumor council of ankara University.

Official Title
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Metastatic Pathologic Fractures: Short Term Results of Endoprosthetic Reconstruction, Intramedullary Nail and Open Reduction Internal Fixation

Conditions
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Pathologic Fracture, Bone Metastases, Metastatic Cancer

Intervention / Treatment
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* Procedure: endoprosthetic reconstruction
* Procedure: Intramedullary nailing
* Procedure: Open reduction internal fixation with plate and screws


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: metastatic pathologic fracture operated via endoprosthesis, intramedullary nail or plate & screws Exclusion Criteria: primary bone tumor conservative management neuromuscular disease periprosthetic fractures less than 1 month follow up
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| endoprosthetic reconstruction<br>This is the group of patients with metastatic pathologic fractures treated with endoprosthesis. For example, proximal femur prosthesis for femoral neck fractures. | Procedure: endoprosthetic reconstruction<br>* This is a type of surgery in which the affected part of the bone and joint is removed, and replaced by a prosthesis.<br>|
| intramedullary nail<br>This is the group of patients with metastatic pathologic fractures treated with intramedullary nail, and additional bone cement if needed. For example, proximal femur nail for trochanteric fractures, or long femoral nail for femoral shaft fractures. | Procedure: Intramedullary nailing<br>* This is a type of surgery in which the affected bone is stabilized by a nail. The affected part could be removed or retained. If removed, the defect is filled with bone cement.<br>|
| open reduction internal fixation with plate and screws<br>This is the group of patients with metastatic pathologic fractures treated with open reduction internal fixation; with plates and screws. For example, reconstruction plates for pelvic fractures or 3.5 locking compression plates for humeral or femur shaft fractures. | Procedure: Open reduction internal fixation with plate and screws<br>* This is a type of surgery in which the affected part of the bone is visualized completely, after the reduction is achieved, the fixation is provided with appropriate plates and screws. Again the affected part could be removed or retained. If removed, the defect is filled with bone cement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Musculoskeletal Tumor Society (MSTS) score | MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function. | Preoperative | 
| Musculoskeletal Tumor Society (MSTS) score | MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function. | Postoperative 1st day | 
| Musculoskeletal Tumor Society (MSTS) score | MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function. | Postoperative 1st week | 
| Musculoskeletal Tumor Society (MSTS) score | MSTS score is for evaluating the patients with bone tumors. It consists of six domains; scored on a 0 to 5 scale and transformed into an overall score ranging from 0 to 100% with a higher score indicating better function. | Postoperative 1st month | 
| Toronto Extremity Salvage Score (TESS) | TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145. | Preoperative | 
| Toronto Extremity Salvage Score (TESS) | TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145. | Postoperative 1st day | 
| Toronto Extremity Salvage Score (TESS) | TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145. | Postoperative 1st week | 
| Toronto Extremity Salvage Score (TESS) | TESS is widely used for the functional assessment of patients following surgery for musculoskeletal tumours. In the TESS system, specific movements for independent living and functionality are questioned and scored.While the worst score is 0, the best score for the lower extremity is 150, and the best score for the upper extremity is 145. | Postoperative 1st month | 
| Visual analog scale (VAS) | VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain. | Preoperative | 
| Visual analog scale (VAS) | VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain. | Postoperative 1st day | 
| Visual analog scale (VAS) | VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain. | Postoperative 1st week | 
| Visual analog scale (VAS) | VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain. | Postoperative 1st month | 
| Upper Extremity Functional Scale (UEFS) | UEFS is a functional scale for upper extremity. It is not specific for tumor patients. | Preoperative | 
| Upper Extremity Functional Scale (UEFS) | UEFS is a functional scale for upper extremity. It is not specific for tumor patients. | Postoperative 1st day | 
| Upper Extremity Functional Scale (UEFS) | UEFS is a functional scale for upper extremity. It is not specific for tumor patients. | Postoperative 1st week | 
| Upper Extremity Functional Scale (UEFS) | UEFS is a functional scale for upper extremity. It is not specific for tumor patients. | Postoperative 1st month | 
| Disabilities of Arm, Shoulder and Hand (DASH) | DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients. | Preoperative | 
| Disabilities of Arm, Shoulder and Hand (DASH) | DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients. | Postoperative 1st day | 
| Disabilities of Arm, Shoulder and Hand (DASH) | DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients. | Postoperative 1st week | 
| Disabilities of Arm, Shoulder and Hand (DASH) | DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients. | Postoperative 1st month | 
| Lower Extremity Functional Scale (LEFS) | LEFS is a functional scale for lower extremity. It is not specific for tumor patients. | Preoperative | 
| Lower Extremity Functional Scale (LEFS) | LEFS is a functional scale for lower extremity. It is not specific for tumor patients. | Postoperative 1st day | 
| Lower Extremity Functional Scale (LEFS) | LEFS is a functional scale for lower extremity. It is not specific for tumor patients. | Postoperative 1st week | 
| Lower Extremity Functional Scale (LEFS) | LEFS is a functional scale for lower extremity. It is not specific for tumor patients. | Postoperative 1st month | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients. | Preoperative | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients. | Postoperative 1st day | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients. | Postoperative 1st week | 
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients. | Postoperative 1st month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days at hospital after surgery | Hospitalization length required after the surgery. | up to 1 month | 
| Survival | Time that the patient lives after the surgery | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone metastasis, pathologic fracture, endoprosthetic reconstruction, intramedullary nailing, open reduction internal fixation, plate and screws