Metastatic Pathologic Fractures, Short Term Results

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825456
• Other study ID #: AnkaraUniOrtho
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2023
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Metastases
• Fractures, Bone
• Metastatic Cancer
• Neoplasm Metastasis
• Pathologic Fracture

Intervention

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 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 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.

Locations

Country	Name	City	State
Turkey	Ankara University Medical Faculty	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Visual analog scale (VAS)	VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.	Preoperative
Primary	Visual analog scale (VAS)	VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.	Postoperative 1st day
Primary	Visual analog scale (VAS)	VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.	Postoperative 1st week
Primary	Visual analog scale (VAS)	VAS is a widely used scale for pain. 0 means no pain where 10 means unbearable pain.	Postoperative 1st month
Primary	Upper Extremity Functional Scale (UEFS)	UEFS is a functional scale for upper extremity. It is not specific for tumor patients.	Preoperative
Primary	Upper Extremity Functional Scale (UEFS)	UEFS is a functional scale for upper extremity. It is not specific for tumor patients.	Postoperative 1st day
Primary	Upper Extremity Functional Scale (UEFS)	UEFS is a functional scale for upper extremity. It is not specific for tumor patients.	Postoperative 1st week
Primary	Upper Extremity Functional Scale (UEFS)	UEFS is a functional scale for upper extremity. It is not specific for tumor patients.	Postoperative 1st month
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Lower Extremity Functional Scale (LEFS)	LEFS is a functional scale for lower extremity. It is not specific for tumor patients.	Preoperative
Primary	Lower Extremity Functional Scale (LEFS)	LEFS is a functional scale for lower extremity. It is not specific for tumor patients.	Postoperative 1st day
Primary	Lower Extremity Functional Scale (LEFS)	LEFS is a functional scale for lower extremity. It is not specific for tumor patients.	Postoperative 1st week
Primary	Lower Extremity Functional Scale (LEFS)	LEFS is a functional scale for lower extremity. It is not specific for tumor patients.	Postoperative 1st month
Primary	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
Primary	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
Primary	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
Primary	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	Days at hospital after surgery	Hospitalization length required after the surgery.	up to 1 month
Secondary	Survival	Time that the patient lives after the surgery	up to 3 months