New Method for Distal Interlocking of Cannulated Intramedullary Nails

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00648479

Enrollment

Registered

2008-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2011-12-28

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

Conditions

Fracture

Keywords

Fracture Fixation

Brief summary

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.

Interventions

DEVICEThe Guiding Star

DEVICEfluoroscopy (OEC 9800 - General Electric)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Signing Informed consent. 2. Conscious patients.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
the outcome will be asses using regular fluoroscopy in the operation room.	—

Outcome results

None listed

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