Metastatic Pathologic Fractures, Short Term Results

Recruiting

• Conditions: Pathologic Fracture; Metastatic Cancer; Bone Metastases
• Interventions: Procedure: Intramedullary nailing; Procedure: endoprosthetic reconstruction; Procedure: Open reduction internal fixation with plate and screws

• Registration Number: NCT05825456
• Lead Sponsor: Ankara University

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.

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 Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intramedullary nail	Intramedullary nailing	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.
endoprosthetic reconstruction	endoprosthetic reconstruction	This is the group of patients with metastatic pathologic fractures treated with endoprosthesis. For example, proximal femur prosthesis for femoral neck fractures.
open reduction internal fixation with plate and screws	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.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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)	Postoperative 1st month	UEFS is a functional scale for upper 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.
Lower Extremity Functional Scale (LEFS)	Postoperative 1st month	LEFS is a functional scale for lower extremity. It is not specific for tumor patients.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ankara University Medical Faculty; 🇹🇷 Ankara, Altindag, Turkey