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Recruiting NCT05825456

Metastatic Pathologic Fractures, Short Term Results

— Observational Pathologic Fracture Bone Metastases Metastatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endoprosthetic reconstruction, Intramedullary nailing, Open reduction internal fixation with plate and screws.
Who it may be relevant to
Registry conditions: Pathologic Fracture, Bone Metastases, Metastatic Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Musculoskeletal Tumor Society (MSTS) score [Time frame: Preoperative]
  • Musculoskeletal Tumor Society (MSTS) score [Time frame: Postoperative 1st day]
  • Musculoskeletal Tumor Society (MSTS) score [Time frame: Postoperative 1st week]
  • Musculoskeletal Tumor Society (MSTS) score [Time frame: Postoperative 1st month]
  • Toronto Extremity Salvage Score (TESS) [Time frame: Preoperative]
  • Toronto Extremity Salvage Score (TESS) [Time frame: Postoperative 1st day]
  • Toronto Extremity Salvage Score (TESS) [Time frame: Postoperative 1st week]
  • Toronto Extremity Salvage Score (TESS) [Time frame: Postoperative 1st month]
  • Visual analog scale (VAS) [Time frame: Preoperative]
  • Visual analog scale (VAS) [Time frame: Postoperative 1st day]
Secondary outcome measures (2)
  • Days at hospital after surgery [Time frame: up to 1 month]
  • Survival [Time frame: up to 3 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Ankara University Medical Faculty — Ankara

Identifiers

NCT: NCT05825456 · AnkaraUniOrtho

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗