Metastatic Pathologic Fractures, Short Term Results

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

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

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer; Bone Metastases; Pathologic Fracture
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Turkey
  • Altindag
    • Ankara, Altindag, Turkey, 06230
      • Recruiting
      • Ankara University Medical Faculty
      • Contact: Merve Dursun Savran, MD; Phone Number: 00905395571557; Email: merve8dursun@gmail.com
      • Contact: Mustafa Onur Karaca, Assc. Proff; Phone Number: 00905324812113; Email: karaca_onur@yahoo.com
      • Sub-Investigator: Merve Dursun Savran, MD
      • Principal Investigator: Mustafa Onur Karaca, Assc. Proff

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population includes patients with metastatic pathologic fractures treated via endoprosthesis, intramedullay nail or plate & screws.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: March 26, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: bone metastasis; intramedullary nailing; open reduction internal fixation; pathologic fracture; endoprosthetic reconstruction; plate and screws
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Wounds and Injuries; Neoplastic Processes; Neoplasm Metastasis; Fractures, Bone; Fractures, Spontaneous
• Other Study ID Numbers: AnkaraUniOrtho

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Final MSTS, TESS, UEFS, LEFS, DASH, WOMAC, VAS will be shared when the study is completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes