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ACTIVE NOT RECRUITING
NCT01428895
NA

Femoral Bone Metastases

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

Summary

Bone is a common site of metastasis for a range of malignancies. Bone metastases have the potential to cause significant morbidity including pain, impairment of ambulation and reduced functional independence. Previous research has shown that pathological fractures are observed in 9 to 29 percent of patients with long bone metastases, and a high proportion of these require surgical intervention to relieve pain and restore function. The goal of this study is to describe the clinical outcomes of patients with femoral metastases at high risk of pathological fracture. Patients referred for treatment of femoral metastases at high risk of fracture will be followed prospectively after undergoing with surgery (± post-operative radiotherapy), or radiotherapy alone. Patient and disease characteristics, ambulatory status and limb function will be documented before treatment. These Clinical outcomes of participants in each treatment group will be measured 6 weeks after treatment, and 3- and 6 months after enrolment, with particular reference to patient-reported outcomes relating to pain, ambulatory status, limb function and quality of life.

Official title: A Prospective Cohort Study of the Role of Surgery and/or Radiotherapy for Bone Metastases of the Femur at High Risk of Pathological Fracture

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2009-03

Completion Date

2027-02

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

PROCEDURE

Surgery Alone

Although we are looking at two groups, this intervention is not protocol specific but is part of the patient's standard management plan. The protocol specific part of the study is completely observational. This involves data being recorded by the attending physician during assessment and patient accounts recorded in the form of questionnaires.

OTHER

Combined Surgery and Radiation therapy

Although we are looking at two groups, this intervention is not protocol specific but is part of the patient's standard management plan. The protocol specific part of the study is completely observational. This involves data being recorded by the attending physician during assessment and patient accounts recorded in the form of questionnaires.

Locations (2)

Mount Sinai Hospital

Toronto, Ontario, Canada

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada