## Protocol Section
### Identification Module
**NCT ID:** NCT06430944

**Brief Title:** Comparative Study Between Single and Double Limb Hip Spica Cast in Fracture Femur in Young Children

**Official Title:** Comparative Study Between Single and Double Limb Hip Spica Cast in Fracture Femur in Young Children

#### Organization Study ID Info
**ID:** MS-318-2023
#### Organization
**Class:** OTHER
**Full Name:** Kasr El Aini Hospital
### Status Module
#### Completion Date
**Date:** 2024-01-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

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

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-01-30

**Type:** ACTUAL

#### Start Date
**Date:** 2022-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**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:** We performed a randomized control trial including 84 children aged two to six years who presented with femoral fractures. They were randomized into two groups; the first was managed by single limb cast fixation (42 patients), and the second was managed by double limb cast fixation (42 patients). The primary outcomes were postprocedural functional outcomes and parents' satisfaction, while the secondary outcomes were the rates of complications.

**Detailed Description:** Femoral fractures are frequent in children and compose 1% to 2% of all pediatric fractures. Conservative management is associated with good results, whether by single or double-limb cast fixations. We aim to compare both procedures regarding functional outcomes, complications, and parents' satisfaction. Eighty-four children were eligible to be included in our study; 42 underwent single limb spica casts, and the other 42 patients underwent double limb spica casts. Both groups had similar baseline characteristics like age, gender, fracture side, and fracture classification.

### Conditions Module

**Conditions:**

- Femur Fracture

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 84

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** A folded towel was placed inside the tubular bandage over the centre of the abdomen, which helped create breathing space inside the cast. The towel's tail was brought towards the neck for easier removal.

Then, a layer of the padded cast was applied using a large width for the body and a narrower one for the lower limb. A thick felt was added over this padding along the free edges of the chest and the leg. The first layer of the cast was applied to the leg and body in an eight-figure manner, taking care to connect the leg to the body securely. The reinforced cast slabs were applied between the body and the lower limb segments. The thigh segment was moulded to maintain a good reduction by keeping the anterolateral of the cast flat or slightly concave. Some clinicians moulded the segment enough to result in ten degrees of initial valgus.

**Intervention Names:**

- Procedure: Placing a hip spica cast for patients with femur fractures

**Label:** Single limb spica casting:

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** One and a half cast was applied in a single limb spica cast, extending to the opposite leg to the knee. Reinforced slabs were applied to hip joints in both limbs

**Intervention Names:**

- Procedure: Placing a hip spica cast for patients with femur fractures

**Label:** Double limb spica cast:

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Double limb spica cast:

- Single limb spica casting:

**Description:** Placing a hip spica cast for patients with femur fractures. These hip spicas are made for each patient to stabilize the fracture in pediatric patients

**Name:** Placing a hip spica cast for patients with femur fractures

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The Flynn evaluation system is based on the presence of leg length inequality, malalignment, pain, and minor and major complications. Each of these criteria is either defined as Excellent, successful or poor.

**Measure:** Flynn's score

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** we do xrays to confirm if there is any loss of reduction of the fracture

**Measure:** loss of reduction

**Time Frame:** 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* children aged 2 to 6 years
* Children with femur shaft fractures

Exclusion Criteria:

* Children younger than 2 years or older than 6 years
* Articular fractures or fractures that cant be managed with a cast
* Old fractures older than 3 weeks

**Maximum Age:** 6 Years

**Minimum Age:** 2 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Kasr Al Ainy-Cairo University- Faculty of Medicine

**State:** Manial

**Zip:** 11956

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000007869

- Term: Leg 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: M8402

- Name: Femoral Fractures

- Relevance: HIGH

- As Found: Femur Fracture

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050723

- Term: Fractures, Bone

- ID: D000005264

- Term: Femoral Fractures

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
