New Method for Distal Interlocking of Cannulated Intramedullary Nails

Hadassah Medical Center

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Fracture

Treatments: Device: The Guiding Star; Device: fluoroscopy (OEC 9800 - General Electric)

Study type: Interventional

Funder types: Other

Identifiers

NCT00648479

EKL-001-HMO-CTIL

Details and patient eligibility

About

We intend to include10 patients in this study and trial. Prior to treatment they will sign an informed consent form, stating that they are acquainted with the surgical procedure and study, and that they consent to participate in the study.

Five patients will undergo regular operation with Universal tibial reamed nail (AO-Synthes) using the fluoroscopy device: OEC 9800 (GENERAL ELECTRIC). five patients will undergo the same operation using the new navigation system:"The Guiding star" method.

The allocation will be random.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signing Informed consent.
2. Conscious patients.

Exclusion criteria

1. Hemodynamic Instability.
2. Multiple system injuries.
3. Pregnancy.
4. Soldiers.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

1

Experimental group

Treatment:

Device: The Guiding Star

2

Active Comparator group

Treatment:

Device: fluoroscopy (OEC 9800 - General Electric)