## Protocol Section
### Identification Module
**NCT ID:** NCT05403879

**Brief Title:** Modified Hook Wiring Technique for Greater Tuberosity Fractures, a Prospective Study

**Official Title:** Modified Hook Wiring Technique for Greater Tuberosity Fractures, a Prospective Study

#### Organization Study ID Info
**ID:** R.22.03.1644
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
### Status Module
#### Completion Date
**Date:** 2023-12-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-03

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-30

**Type:** ACTUAL

#### Start Date
**Date:** 2022-03-23

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2022-06-03
**Type:** ACTUAL
**Study First Submit Date:** 2022-05-31
**Study First Submit QC Date:** 2022-05-31
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mansoura University

#### Responsible Party

**Investigator Affiliation:** Mansoura University

**Investigator Full Name:** Amr Elshahhat, MD.

**Investigator Title:** lecturer of orthopedics

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** the purpose of this study is to assess functional and radiological outcome of open reduction and internal fixation of isolated displaced greater tuberosity fractures (more than 5mm displacement) in adults advocating modified hook wiring with a follow-up period of one year.

**Detailed Description:** after being informed about the study and potential risks, all enrolled cases giving informed consent will undergo fixation of their fractured greater tuberosity, then physiotherapy. patients will be followed up till full union, clinical and radiological follow up for at least one year utilizing approved clinical scores and radiological criteria for healing. any complication will be recorded.

### Conditions Module

**Conditions:**

- Greater Tuberosity Fractures

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: fixation of greater tuberosity fractures

**Label:** cases undergoing fixation of fractured greater tuberosity

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- cases undergoing fixation of fractured greater tuberosity

**Description:** deltopectoral approach for shoulder, then open reduction and fixation of displaced greater tuberosity fractures using hooked Kirshner wires

**Name:** fixation of greater tuberosity fractures

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** postoperative assessing pain, range of motion, function of shoulder. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition

**Measure:** functional outcome using American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment score

**Time Frame:** at least one year follow up

#### Secondary Outcomes

**Description:** estimate time till radiological healing on follow-up radiographs

**Measure:** healing time

**Time Frame:** anticipated 2-4 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Patients presented and admitted at Mansoura Trauma, emergency hospital affiliated to Mansoura university, with acute isolated displaced GT fractures ( more than 5mm displacement), with/without glenohumeral dislocations, with age between 18years to 50 years.

Exclusion Criteria:

1. Skeletally immature patients (less than 18 years), age more than 50 years.
2. Open and pathological fractures
3. Associated proximal humeral fractures
4. History of previous GH dislocations
5. History of previous shoulder injuries or surgeries

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mansoura

**Country:** Egypt

**Facility:** Mansoura university hospital

**State:** Dakahlia

**Zip:** 35511

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000070599

- Term: Shoulder 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: M15592

- Name: Shoulder Fractures

- Relevance: HIGH

- As Found: Greater Tuberosity Fractures

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M602

- Name: Shoulder Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050723

- Term: Fractures, Bone

- ID: D000012784

- Term: Shoulder Fractures

### Misc Info Module

- Version Holder: 2024-05-24
