## Protocol Section
### Identification Module
**NCT ID:** NCT00648479

**Brief Title:** New Method for Distal Interlocking of Cannulated Intramedullary Nails

**Official Title:** New Method for Distal Interlocking of Cannulated Intramedullary Nails

#### Organization Study ID Info
**ID:** EKL-001-HMO-CTIL
#### Organization
**Class:** OTHER
**Full Name:** Hadassah Medical Organization
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-12-28

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-12-25

**Overall Status:** TERMINATED

**Status Verified Date:** 2011-12

#### Study First Post Date
**Date:** 2008-04-01
**Type:** ESTIMATED
**Study First Submit Date:** 2008-03-17
**Study First Submit QC Date:** 2008-03-31
**Why Stopped:** the company does not want to proceed yet with the study
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hadassah Medical Organization

#### Responsible Party

**Old Name Title:** Hadassah Medical Organization

### Description Module

**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.

### Conditions Module

**Conditions:**

- Fracture

**Keywords:**

- Fracture Fixation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: The Guiding Star

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Device: fluoroscopy (OEC 9800 - General Electric)

**Label:** 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Name:** The Guiding Star

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- 2

**Name:** fluoroscopy (OEC 9800 - General Electric)

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** the outcome will be asses using regular fluoroscopy in the operation room.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Signing Informed consent.
2. Conscious patients.

Exclusion Criteria:

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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M26370

- Name: Fractures, Bone

- Relevance: HIGH

- As Found: Fracture

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050723

- Term: Fractures, Bone

### Misc Info Module

- Version Holder: 2024-05-24
