## Protocol Section
### Identification Module
**NCT ID:** NCT06436352

**Brief Title:** Does Capsulotomy in Closed Reduction of Femoral Neck Fractures Decrease Incidence of Avascular Necrosis?

**Official Title:** Does Capsulotomy in Closed Reduction of Femoral Neck Fractures Decrease Incidence of Avascular Necrosis?

#### Organization Study ID Info
**ID:** MD-143-2019
#### Organization
**Class:** OTHER
**Full Name:** Kasr El Aini Hospital
### Status Module
#### Completion Date
**Date:** 2023-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-02-01

**Type:** ACTUAL

#### Start Date
**Date:** 2021-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-24
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Kasr El Aini Hospital

#### Responsible Party

**Investigator Affiliation:** Kasr El Aini Hospital

**Investigator Full Name:** Ahmed Omar Sabry

**Investigator Title:** Dr.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Femur's neck injuries are frequently encountered fractures. They are usually due to high energy or low energy indirect trauma. Healing of these fractures is usually hindered due to "avascular necrosis (AVN)" or "non-union" of the Femur's head. This study looks forward to investigating the impact of capsulotomy and internal fixation in lowering the incidence of complications and improving the functional outcomes.

**Detailed Description:** Femoral neck fractures constitute a frequent orthopaedic, usually due to indirect assault. It primarily affects older people, with younger people accounting for barely 2 - 3%. Nevertheless, since transportation has recently advanced rapidly, high-energy trauma has become increasingly widespread. The prevalence of femur neck injuries among youth is likewise growing in hospitals by an estimated rate of about 6000 yearly. Hip blood supply is especially important while addressing femoral neck fractures. Blood supply emerges from the capsular, intramedullary, and the ligamentum teres vessels. In adults, capsular vessels provide most of the femur's head blood supply. The arteries originate out of the "medial and lateral circumflex femoral arteries". Those areteries are in turn branced out of the profunda femoris in seventy nine of the population. There is an exception for 20% of population where one vessel originates from the femoral artery. Moreover, there is 1% of the population in which both vessels originate from the femoral artery. The effectiveness and benefits of capsulotomy in treating femur's neck fractures among youth were compared to "closed reduction and internal fixation (CRIF)". AVN and non-union are the most prevalent and difficult complications. In terms of "trauma degree index" (incision length, amount of lost blood, and operative time), capsulotomy and internal fixation are less effective than CRIF. However, it outperforms CRIF in functional effectiveness (Harris Hip Score.

Some differences exist between capsulotomy reduction and internal fixation. First and foremost is proper anatomical reduction. With direct sight and adequate exposure, an acceptable anatomical reduction can be obtained, laying the groundwork for the healing of fractures. Furthermore, it could unlock certain retinacular arteries that have been temporarily blocked by kinking or stretching, allowing for the the restoration of some vascular function. The second principal is "stable internal fixation" that can be achieved by proper placement of the screws under direct visualization.

Researchers have concluded that evacuating of the hematoma significantly lowers the capsular pressure and improves pulse perfusion of the femur's head. Our study aims to investigate the efficiency of capsulotomy in enhancing the healing process of femur's neck fractures.

### Conditions Module

**Conditions:**

- Femoral Neck Fractures

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** A prospective research was carried out between January 2021 and February 2023. Patients were randomized into two groups: Group I: cases with capsulotomy and Group II: cases without capsulotomy. The study was conducted after an ethical approval was obtained.

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** before fixation, We perform a guide wire insertion passing anterior to the Greater Trochanter and the neck is done. then passing a pointed Schanz 5 or 6mm ± scalpel, under X-ray in AP-lateral views until reaching the capsule (intra trochanteric line). Aspiration of hematoma with suction was done.

**Intervention Names:**

- Procedure: Capsulotomy and fixation

**Label:** Group I: cases with capsulotomy during fixation

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** we fix the fracture without capsulotomy

**Intervention Names:**

- Procedure: Fixation only

**Label:** Group II: cases without capsulotomy during fixation

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group I: cases with capsulotomy during fixation

**Description:** Firstly, Guide wire insertion passing anterior to the GT and the neck is done. then passing a pointed Schanze 5 or 6 ± scalpel, under X-ray in AP-lateral views until reaching the capsule (intra trochanteric line). Aspiration of hematoma with suction was done.

Then we fix the fracture by proceeding with drilling over the wires using a "3.6 mm cannulated drill bit". Then, we place three "7.0 mm or 7.3 mm cannulated cancellous screws" over the wires. In younger patients with thick cancellous bone, a "cannulated tap" may be required to precut the thread. A washer may be used to prevent the screw head from penetrating the thin cortex.

**Name:** Capsulotomy and fixation

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Group II: cases without capsulotomy during fixation

**Description:** we fix the fracture by proceeding with drilling over the wires using a "3.6 mm cannulated drill bit". Then, we place three "7.0 mm or 7.3 mm cannulated cancellous screws" over the wires. In younger patients with thick cancellous bone, a "cannulated tap" may be required to precut the thread. A washer may be used to prevent the screw head from penetrating the thin cortex.

**Name:** Fixation only

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. Results can be recorded and calculated online. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.

**Measure:** Harris hip score

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** in ml

**Measure:** Intra-operative blood loss

**Time Frame:** during the operation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Skeletally mature patients with fracture neck femur who will undergo urgent surgery within 48 hours.
* Male and female patients of any garden classification of femoral neck fractures
* within age group from 18 - 55 years

Exclusion Criteria:

* Patients of age below 18 years or above 55 years.
* those with metabolic bone disease, pathological fractures, stress fracture or delayed presentation more than 48 hours were excluded.

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Kasr Alainy Hospital - Faculty of Medicine - Cairo University

**Zip:** 11765

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000010335

- Term: Pathologic Processes

- ID: D000006620

- Term: Hip Fractures

- ID: D000005264

- Term: Femoral Fractures

- ID: D000025981

- Term: Hip Injuries

- ID: D000007869

- Term: Leg Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M26370

- Name: Fractures, Bone

- Relevance: HIGH

- As Found: Fracture

- ID: M12284

- Name: Necrosis

- Relevance: HIGH

- As Found: Necrosis

- ID: M8403

- Name: Femoral Neck Fractures

- Relevance: HIGH

- As Found: Femoral Neck Fractures

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M9696

- Name: Hip Fractures

- Relevance: LOW

- As Found: Unknown

- ID: M8402

- Name: Femoral Fractures

- Relevance: LOW

- As Found: Unknown

- ID: M23105

- Name: Hip Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009336

- Term: Necrosis

- ID: D000050723

- Term: Fractures, Bone

- ID: D000005265

- Term: Femoral Neck Fractures

### Misc Info Module

- Version Holder: 2024-05-31
