Metastatic Pathologic Fractures, Short Term Results

Sponsor

Ankara University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05825456

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pathologic Fracture Bone Metastases Metastatic Cancer	Procedure: endoprosthetic reconstruction Procedure: Intramedullary nailing Procedure: Open reduction internal fixation with plate and screws

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
endoprosthetic reconstruction 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 This is a type of surgery in which the affected part of the bone and joint is removed, and replaced by a prosthesis.
intramedullary nail 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 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.
open reduction internal fixation with plate and screws 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 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.

Arm

Intervention/Treatment

endoprosthetic reconstruction

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

This is a type of surgery in which the affected part of the bone and joint is removed, and replaced by a prosthesis.

intramedullary nail

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

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.

open reduction internal fixation with plate and screws

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

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.

Outcome Measures

Primary Outcome Measures

Musculoskeletal Tumor Society (MSTS) score [Preoperative]
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.
Musculoskeletal Tumor Society (MSTS) score [Postoperative 1st day]
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.
Musculoskeletal Tumor Society (MSTS) score [Postoperative 1st week]
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.
Musculoskeletal Tumor Society (MSTS) score [Postoperative 1st month]
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.
Toronto Extremity Salvage Score (TESS) [Preoperative]
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.
Toronto Extremity Salvage Score (TESS) [Postoperative 1st day]
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.
Toronto Extremity Salvage Score (TESS) [Postoperative 1st week]
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.
Toronto Extremity Salvage Score (TESS) [Postoperative 1st month]
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.
Visual analog scale (VAS) [Preoperative]
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Visual analog scale (VAS) [Postoperative 1st day]
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Visual analog scale (VAS) [Postoperative 1st week]
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Visual analog scale (VAS) [Postoperative 1st month]
VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.
Upper Extremity Functional Scale (UEFS) [Preoperative]
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Upper Extremity Functional Scale (UEFS) [Postoperative 1st day]
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Upper Extremity Functional Scale (UEFS) [Postoperative 1st week]
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Upper Extremity Functional Scale (UEFS) [Postoperative 1st month]
UEFS is a functional scale for upper extremity. It is not specific for tumor patients.
Disabilities of Arm, Shoulder and Hand (DASH) [Preoperative]
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Disabilities of Arm, Shoulder and Hand (DASH) [Postoperative 1st day]
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Disabilities of Arm, Shoulder and Hand (DASH) [Postoperative 1st week]
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Disabilities of Arm, Shoulder and Hand (DASH) [Postoperative 1st month]
DASH is a widely used functional scale for upper extremity. It is not specific for tumor patients.
Lower Extremity Functional Scale (LEFS) [Preoperative]
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
Lower Extremity Functional Scale (LEFS) [Postoperative 1st day]
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
Lower Extremity Functional Scale (LEFS) [Postoperative 1st week]
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
Lower Extremity Functional Scale (LEFS) [Postoperative 1st month]
LEFS is a functional scale for lower extremity. It is not specific for tumor patients.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Preoperative]
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Postoperative 1st day]
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Postoperative 1st week]
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Postoperative 1st month]
WOMAC is a widely used functional scale for lower extremity. It is not specific for tumor patients.

Secondary Outcome Measures

Days at hospital after surgery [up to 1 month]
Hospitalization length required after the surgery.
Survival [up to 3 months]
Time that the patient lives after the surgery