## Protocol Section
### Identification Module
**NCT ID:** NCT06429267

**Brief Title:** Investigation Of Bioabsorbable Screws In Pediatric Orthopedic Surgery

**Official Title:** Comprehensive Investigation of Bioabsorbable Screws in Pediatric Orthopedic Surgery: Mechanical Properties, Long-term Performance, and Practical Applications

#### Organization Study ID Info
**ID:** 6360
#### Organization
**Class:** OTHER
**Full Name:** Louisiana State University Health Sciences Center in New Orleans
### Status Module
#### Completion Date
**Date:** 2026-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-26

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-01
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Louisiana State University Health Sciences Center in New Orleans

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. Conducted by the pediatric orthopedic department at Children's Hospital New Orleans, the study aims to evaluate the effectiveness of these screws in bone healing over key post-operative intervals (6 weeks, 6 months, and 1 year). It seeks to determine if bioabsorbable screws offer significant advantages over metal screws in terms of reducing the need for secondary surgeries, based on their hypothesized noninferiority in complication rates. Participants will be randomly assigned to receive either bioabsorbable or metal (titanium or stainless steel) screws after obtaining informed consent from a parent or guardian.

**Detailed Description:** This study is a prospective randomized controlled trial to evaluate clinical outcomes associated with the use of bioabsorbable screws compared to conventional metal screws in children aged 0 to 18 who are undergoing surgical fixation in the setting of trauma such as medial epicondyle fractures of the elbow or elective procedures. The research will be conducted within the pediatric orthopedic department at CHNOLA, and participants will be assessed at key intervals, including 6 weeks, 6 months, and 1 year post-operation post-operation. The primary objective of this study is to assess and compare the effectiveness of conventional metal screws and bioabsorbable screws in bone healing. This study aims to determine whether bioabsorbable screws are significantly superior to conventional titanium screws. The investigators hypothesize bioabsorbable screws are significantly noninferior to conventional metal screws in terms of complications based on prior surgical constructs that demonstrate bioabsorbable screws eliminate the need for a second surgery After informed consent has been obtained from the parents of patients, eligible patients undergoing cannulated screw fixation will be randomized into two groups: one group who will receive bioabsorbable screws and the other group who will receive metal screws (titanium or stainless steel).

### Conditions Module

**Conditions:**

- Pediatric

- Fracture

- Orthopedic Devices Associated With Misadventures, Surgical Instruments, Materials and Devices (Including Sutures)

- Patient Satisfaction

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Participants will be randomized to one of two groups which will determine the type of screw (stainless steel or bioabsorbable) in their surgery.

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients that are randomly assigned to receive traditional, metal screws

**Intervention Names:**

- Device: Metal/Titanium Screw

**Label:** Control Group (Receiving Metal Screws)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Patients that are randomly assigned to receive Bioabsorbable screws

**Intervention Names:**

- Device: Bioabsorbable Screw

**Label:** Experimental Group (Receiving Bioabsorbable Screws)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental Group (Receiving Bioabsorbable Screws)

**Description:** Bioabsorbable screw that redissolves into the bone. Mineral fibers are composed of Silicon Dioxide (SiO2), Sodium Oxide, Calcium Oxide, Magnesium Oxide, Boron Trioxide, and Phosphorous Pentoxide

**Name:** Bioabsorbable Screw

**Other Names:**

- Ossiofiber

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control Group (Receiving Metal Screws)

**Description:** Traditional metal screw used in fracture fixation that requires hardware removal

**Name:** Metal/Titanium Screw

**Other Names:**

- OrthoPediatrics

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Pain, Upper Extremity and Mobility. These questionnaires are scored using T scores. For pain, a higher score is a worse outcome. For mobility and upper extremity, a lower score is a worse outcome. Min value is 0 and max is 100 for all.

**Measure:** Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys

**Time Frame:** 6 weeks, 6 months, 1 year

#### Secondary Outcomes

**Description:** Any complications of surgery (infection etc)

**Measure:** Complications

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Primary fractures requiring fixation with cannulated screws

Exclusion Criteria:

* Children ten years old or under with a fracture requiring screws to be fixed across the growth plate (physis)
* Secondary fractures
* Non-union fractures
* Tibial tubercle osteotomies (TTOs)
* Slipped capital femoral epiphysis (SCFEs)
* Unable or unwilling to provide informed consent or parental/guardian consent for participants under 18 years of age
* Allergies or contraindications to screw materials

**Healthy Volunteers:** True

**Maximum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sculpe@lsuhsc.edu

**Name:** Sylvia Culpepper, MS

**Phone:** 2283270278

**Role:** CONTACT

**Contact 2:**

**Name:** Carter Clement, MD, MBA

**Phone:** (504) 896-9569

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New Orleans

**Contacts:**

***Contact 1:***

- **Email:** sculpe@lsuhsc.edu

- **Name:** Sylvia Culpepper, MS

- **Phone:** 228-327-0278

- **Role:** CONTACT

***Contact 2:***

- **Name:** Carter Clement, MD, MBA

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Sylvia Culpepper, MS

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Children's Hospital New Orleans

**State:** Louisiana

**Status:** RECRUITING

**Zip:** 70118

#### Overall Officials

**Official 1:**

**Affiliation:** LSUHSC

**Name:** Carter Clement, MD, MBA

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** all IPD that underlie results in a publication

**IPD Sharing:** YES

## Derived Section

### 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: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

### Intervention Browse Module - Browse Leaves

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M11269

- Name: Magnesium Oxide

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M15630

- Name: Silicon

- Relevance: LOW

- As Found: Unknown

- ID: M5173

- Name: Boron

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
