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Internal Fixation of Hip Fractures Using Intraoperative Simultaneous Two Axis View

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01524718
Enrollment
60
Registered
2012-02-02
Start date
2012-09-30
Completion date
2013-03-31
Last updated
2012-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture Neck of Femur

Keywords

radiation, time surgery

Brief 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.

Interventions

RADIATIONImaging with two X-ray image intensifiers

Two fluoroscopy apparatus one in the AP plane and the other as the axial plane.

Sponsors

Clalit Health Services
CollaboratorOTHER
Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Time of surgery5 hours - operation timetime of operation

Secondary

MeasureTime frameDescription
X-ray time during surgery5 hours - operation timeradiation time
Accuracy of nail position5 hours - operation time
Accuracy of reduction5 hours - operation time

Countries

Israel

Contacts

Primary ContactYaron Shagra Brin, MD
yaronbrin@gmail.com+97297472549
Backup ContactEzequiel Palmanovich, MD
ezepalm@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026