Pathological Subtrochanteric Fractures in 194 Patients

Subtrochanteric Femur Fractures Clinical Trial

Official title:

Pathological Subtrochanteric Fractures in 194 Patients. A Comparison of Outcome After Surgical Treatment of Pathological and Non-pathological Fractures.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520480
• Other study ID #: 206/02
• Status: Completed
• Phase: N/A
• First received: January 25, 2012
• Last updated: January 29, 2012
• Start date: January 1999
• Est. completion date: January 2009

Study information

• Verified date: January 2012
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

In this study, the investigators analyze a consecutive series of patients operated for pathological subtrochanteric femur fracture to describe survival and reoperation rates after surgery and to identify risk factors for death. Moreover, the investigators include a cohort of patients with non-pathological subtrochanteric fractures for comparison.

Description:

The Scandinavian Sarcoma Group (SSG) has initiated a Skeletal Metastasis Register in 1999. The Register is a quality-control database which prospectively collects individual-based information on patients operated for skeletal metastases in the long bones and pelvis. Data on patient identity, age, sex, primary tumor, location of metastases, type of pathological fracture, and perioperative treatment were gathered. Information concerning surgical procedures such as method of fixation, type of implant, and postoperative complications are registered. Moreover, some clinical data such as pain levels (no, light, moderate, strong, or severe pain), pain medication use, mobility, and the Karnofsky performance score are recorded.

We will identify all patients surgically treated for pathological subtrochanteric femur fractures during 1999-2009.

The Stockholm Hip Fracture Group provides data on the reference group. During 2003, a consecutive series of patients with acute non-pathological subtrochanteric femur fractures treated in Stockholm were included in a prospective cohort study. The regional ethical review board located at the Karolinska Institutet approved the study (DNR 206/02).

The aim of this study is to analyze survival and reoperation rates of patients operated for pathological subtrochanteric femur fracture. We want compare those findings with a cohort of patients with non-pathological subtrochanteric fractures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• All patients with pathological subtrochanteric femur fractures register in the Scandinavian Sarcoma Group Register

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Hip Fractures
• Subtrochanteric Femur Fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital