Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View

Fracture Neck of Femur Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01524718
• Other study ID #: MMC-twoaxis-001.il
• Status: Not yet recruiting
• Phase: N/A
• First received: January 10, 2012
• Last updated: September 2, 2012
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: September 2012
• Source: Meir Medical Center
• Contact: Yaron Shagra Brin, MD
• Phone: +97297472549
• Email: yaronbrin[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Hip fractures are one of the most frequent operated fractures procedures in orthopedics, with a world wide annual incidence of approximately 1.7 million. These fractures are associated with substantial morbidity and mortality. As populations age and life expectancy increases worldwide, the incidence of these fractures is likely to raise, expected to triple in the next 50 years. The use of fluoroscopy and resultant exposure to radiation, is an integral part of surgical procedures aiming to reduce and fixate the fractured femur. The risk of contracting cancer is significantly higher for an orthopedic surgeon as Hip surgery is a major slice of the total radiation dose. Optimal positioning and control of the imaging intensifier device may result in significant reduction of radiation dose and time and in substantial shortening of the procedure.

The investigators hypothesis is that this technique would substantially shorten procedure time and reduce unnecessary radiation exposure for both the patient and the medical staff. Furthermore, by using this technique the investigators can eliminate the need for fluoroscopy technician during the surgery, as there is no need to alternate fluoroscopy views.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with intertrochanteric femoral fracture who are going to be operated by closed reduction and internal fixation with an intramedullary nail.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fracture Neck of Femur

Intervention

Radiation:
• Imaging with two X-ray image intensifiers
Two fluoroscopy apparatus one in the AP plane and the other as the axial plane.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar - Saba

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of surgery	time of operation	5 hours - operation time	Yes
Secondary	X-ray time during surgery	radiation time	5 hours - operation time	Yes
Secondary	Accuracy of nail position		5 hours - operation time	Yes
Secondary	Accuracy of reduction		5 hours - operation time	Yes