Metastatic Pathologic Fractures, Short Term Results

Trial Title: Metastatic Pathologic Fractures, Short Term Results

NCT ID: NCT05825456

Condition: Pathologic Fracture
Bone Metastases
Metastatic Cancer

Conditions: Official terms:
Neoplasm Metastasis
Fractures, Bone
Fractures, Spontaneous

Conditions: Keywords:
bone metastasis
pathologic fracture
endoprosthetic reconstruction
intramedullary nailing
open reduction internal fixation
plate and screws

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: endoprosthetic reconstruction
Description: This is a type of surgery in which the affected part of the bone and joint is removed, and replaced by a prosthesis.
Arm group label: endoprosthetic reconstruction

Intervention type: Procedure
Intervention name: Intramedullary nailing
Description: 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.
Arm group label: intramedullary nail

Intervention type: Procedure
Intervention name: Open reduction internal fixation with plate and screws
Description: 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 group label: open reduction internal fixation with plate and screws

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ankara University Medical Faculty

Address:
City: Ankara
Zip: 06230
Country: Turkey

Status: Recruiting

Contact:
Last name: Merve Dursun Savran, MD

Phone: 00905395571557
Email: merve8dursun@gmail.com

Contact backup:
Last name: Mustafa Onur Karaca, Assc. Proff

Phone: 00905324812113
Email: karaca_onur@yahoo.com

Investigator:
Last name: Merve Dursun Savran, MD
Email: Sub-Investigator

Investigator:
Last name: Mustafa Onur Karaca, Assc. Proff
Email: Principal Investigator

Start date: January 1, 2022

Completion date: January 1, 2025

Lead sponsor:
Agency: Ankara University
Agency class: Other

Source: Ankara University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05825456