Comparison of the Results of Treatment by Gamma Nail Versus Dynamic Hip Screw for Unstable Intertrochanteric Hip Fractures

Intertrochanteric Fractures of the Hip Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01238068
• Other study ID #: TAMSC-10-OS-10-357-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: October 26, 2010
• Last updated: November 9, 2010
• Start date: November 2010
• Est. completion date: November 2011

Study information

• Verified date: October 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: ortal segal, MD
• Phone: 972-52-60172
• Email: ortal_San[@]yahoo.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study hypothesis is the the results of the use of Gamma nail will be superior to the use of Dynamic hip screw for unstable intertrochantric hip fracture.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients diagozied with acute intertrochantric unstable fracture

• a minimum minimental score of 6

• ability to walk 500 meters indepedently

Exclusion Criteria:

• pathological fracture

• multiple fractures

• neurological conditions

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Fractures
• Intertrochanteric Fractures of the Hip

Intervention

Device:
• gamma nail stryker
for acute unstable pertrochantric fractures the subjects will be treated randomaly with either Gamma nail device Vs Dynamic hip screw

Locations

Country	Name	City	State
Israel	Tel Aviv Medical center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hip function score	at the last clinical visit (1 year) the patient will perform hip score testing and record.	1 year	No
Secondary	x-ray, surgical outcome	in the last clincial visit x ray finding will be record and the overall surgical outcome (infection, bleeding etc.) will be record	1 year	No