Metastatic Pathologic Fractures, Short Term Results

NCT ID: NCT05825456

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2026-01-01

Brief Summary

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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

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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.

Conditions

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Pathologic Fracture Bone Metastases Metastatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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endoprosthetic reconstruction

This is the group of patients with metastatic pathologic fractures treated with endoprosthesis. For example, proximal femur prosthesis for femoral neck fractures.

endoprosthetic reconstruction

Intervention Type PROCEDURE

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.

Intramedullary nailing

Intervention Type PROCEDURE

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.

Open reduction internal fixation with plate and screws

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Merve Dursun Savran, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara University Medical Faculty

Ankara, altindag, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Merve Dursun Savran, MD

Role: primary

00905395571557

Mustafa Onur Karaca, Assc. Proff

Role: backup

00905324812113

Other Identifiers

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AnkaraUniOrtho

Identifier Type: -

Identifier Source: org_study_id

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