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Metastatic Pathologic Fractures, Short Term Results

A

Ankara University

Status

Enrolling

Conditions

Metastatic Cancer
Pathologic Fracture
Bone Metastases

Treatments

Procedure: Intramedullary nailing
Procedure: Open reduction internal fixation with plate and screws
Procedure: endoprosthetic reconstruction

Study type

Observational

Funder types

Other

Identifiers

NCT05825456
AnkaraUniOrtho

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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