search
Back to results

Femoral Pediatric Fractures. Walking Spica Cast vs Synthetic Pants

Primary Purpose

Femoral Shaft Fracture, Pediatric ALL

Status
Withdrawn
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Synthetic pants
Spica cast
Sponsored by
Universidad Autonoma de Nuevo Leon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Shaft Fracture focused on measuring femoral pediatric shaft fractures, walking spica cast, synthetic pants

Eligibility Criteria

18 Months - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Simple fractures (transverse or short oblique fracture)
  • Less than 2 cm of shortening
  • Independent walking ability
  • Closed fractures
  • Isolated shaft fractures
  • Low energy
  • Written informed consent by the parents

Exclusion Criteria:

  • Polytraumatized patients
  • Cranial trauma or spinal cord injury
  • Articular extension of the fracture
  • History of femoral shaft fracture

Sites / Locations

  • Hospital Universitario "Dr. José E. González". Universidad Autónoma de Nuevo León

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Spica cast

Synthetic fabric

Arm Description

Standard practice for the management of the femoral shaft fractures.

Offer resistance, durability and low weight to treatment of femoral shaft fractures

Outcomes

Primary Outcome Measures

Bone consolidation
Evaluate the bone consolidation during the follow-up, with standard two position x-ray (anteroposterior and lateral) according to Stans classification. When grade 0 represents the absence of indentifiable bone callus; grade 1 primary bone callus with little or no periosteal new bone formation; grade 2 periosteal new bone formation on both sides of bone, and grade 3 represents periosteal new bone formation in three or four sides of the bone

Secondary Outcome Measures

Bone angulation
Evaluate and compare the angulation in all planes (varus, valgus, antecurvature or recurvatum) in two standard x-ray images (anteroposterior and lateral)
Bone shortening
The shortening it was measured in centimeters in two standard X-ray projections, and compared between the two groups

Full Information

First Posted
March 10, 2020
Last Updated
March 23, 2023
Sponsor
Universidad Autonoma de Nuevo Leon
search

1. Study Identification

Unique Protocol Identification Number
NCT04311866
Brief Title
Femoral Pediatric Fractures. Walking Spica Cast vs Synthetic Pants
Official Title
Comparative Study in the Clinical Efficacy, Satisfaction and Complications While Treating Walking Spica Cast vs Synthetic Pants in the Management of Pediatric Low-energy Femoral Shaft Fracture. Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of material for treatment of the patients
Study Start Date
January 4, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Nuevo Leon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Femoral pediatric shaft fractures are a common orthopedic injury. Conservative treatment is still the preferred method by orthopedic surgeons. The walking spica cast is used in patients between 1 year old and 6 years old, in patients with isolated and low-energy fractures. The use of synthetic materials is preferred (fiber glass) for resistance, durability and low weight makes them optimal.
Detailed Description
Femoral shaft fractures are the most common orthopedic injury among the femoral fractures in pediatric patients. Approximately 70% of them, are femoral shaft fractures. In the management of this fractures, child abuse has to be discarded, considering age, history, physical examination and radiographic findings.(1) Gross et al suggest that up to 80% of the children that have not yet learned to walk, have been victims of abuse. Moreover, it is important to discard any other condition that could make the child prone to fractures, myelomeningocele, cerebral palsy, osteogenesis imperfecta, non-ossifying fibroma, etc. Once the diagnosis is made, several variables have to be brought to account, in order to select a treatment method: associated injuries, fracture characteristics, the capability of obtaining an appropriate reduction, familiar situation and costs. Conservative treatment is still the preferred method by orthopedic surgeons because of its cost and effectivity. Pavlik harness are used in newborns and children up to 6-12 months, it maintains the fracture aligned, it is comfortable and avoids the risk of complications associated to the cast contact with the skin.(1,2) The walking spica cast is used in patients between 1 and 6 years old. Generally this method of treatment is indicated isolated and low-energy fractures.(1) Patients in this group of age with high-energy or comminuted fractures, may require traction prior to the application of the cast. Also, positive Telescope Test may make the patient candidate to traction. In this test, under general anesthesia, a gentile force is applied along the femur, if a 3 or more centimeters shortening is present, the patient has a 20-fold risk of unacceptable shortening.(3) For the application of a cast in femoral fractures, a flexion of 90° in the hip and knee joints is preferred, because this position relaxes the flexor muscles and the hamstrings, besides, it has a lower incidence of loss of reduction and more easy easiness for transportation.(4) in previous studies there has been a loss of reduction 9 times greater in patients immobilized with the knee in less of 50°. The risk of loss of reduction is elevated twice for each centimeter of initial shortening. (1 cm: 12%; 3 cm: 50%)(5) A long cast is applied on the affected extremity, while a gentile traction is maintained and a valgus mold is applied on the fracture site. The remaining part of the cast is applied to the line of the nipples. Caution has to be taken when applying traction to the extremity because the pressure on the popliteus fossa and peroneal nerve. The use of synthetic materials is preferred (glass fiber), resistance, durability and low weight makes them optimal. To give some extra strength to the cast, fiber strips are placed anterior and posterior at the level of the groin, this can facilitate the transportation of the patient avoiding the use of a bar. A radiographic follow-up during the first 10 days is important because the position of the reduction during the first 7 through 10 days, predicts in a important manner the final result. The cast is retired at 6 - 8 weeks. The rehabilitation therapy is not usually necessary and the parents need to be advised about a residual limp, which can last a few months. The patient and his family´s life quality has an important role in this kind of injuries. The immediate application of a spica cast substitutes the bed traction prior to the cast application.(4) Multiple adequations have to be made: vehicle safety and transportation, daily supervision, education, home mobility, and hygiene. The home transportation has been identified as the most problematic issue and as a solution to this problem, families have to acquire a wheel chair. (1,4) Hygiene represents a prevalent issue, of minor importance, and parents should be educated about this problem. The position of the cast at 90°-90° may help to solve this issue. Surprisingly, the need to be absent at work is not the most mentioned problem by parents,. An average of 3 weeks out of work was needed by parents to take care of their child. Education and learning of the child is vital because of the development and socialization process that takes place during this age. (4) A home tutor works adequately, even though this represents a economic burden to the family. Activity recovery after retrieval of the cast, such as running and playing starts until 25 days. Physical education should be postponed for one month after retrieval. (4) Surgical treatment is indicated in patients in school age, because of the quality life burden the prolonged immobilization represents. Among those treatments, the options are external fixation, intramedullary flexible nails, and plate fixation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Shaft Fracture, Pediatric ALL
Keywords
femoral pediatric shaft fractures, walking spica cast, synthetic pants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spica cast
Arm Type
Active Comparator
Arm Description
Standard practice for the management of the femoral shaft fractures.
Arm Title
Synthetic fabric
Arm Type
Experimental
Arm Description
Offer resistance, durability and low weight to treatment of femoral shaft fractures
Intervention Type
Device
Intervention Name(s)
Synthetic pants
Intervention Description
The use of synthetic materials is preferred (glass fiber), resistance, durability and low weight makes them optimal. To give some extra strenght to the cast, fiber strips are placed anterior and posterior at the level of the groin, this can facilitate the transportation of the patient avoiding the use of a bar.
Intervention Type
Device
Intervention Name(s)
Spica cast
Intervention Description
The use of the spica cast is a standard practice for the management of the femoral shaft fractures, however its use, under some circumstances has been related to a wrong management of the cast, auto-retrieval, patient discomfort, and a difficult situation trying to maintain personal hygiene for the patient.
Primary Outcome Measure Information:
Title
Bone consolidation
Description
Evaluate the bone consolidation during the follow-up, with standard two position x-ray (anteroposterior and lateral) according to Stans classification. When grade 0 represents the absence of indentifiable bone callus; grade 1 primary bone callus with little or no periosteal new bone formation; grade 2 periosteal new bone formation on both sides of bone, and grade 3 represents periosteal new bone formation in three or four sides of the bone
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Bone angulation
Description
Evaluate and compare the angulation in all planes (varus, valgus, antecurvature or recurvatum) in two standard x-ray images (anteroposterior and lateral)
Time Frame
42 days
Title
Bone shortening
Description
The shortening it was measured in centimeters in two standard X-ray projections, and compared between the two groups
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Simple fractures (transverse or short oblique fracture) Less than 2 cm of shortening Independent walking ability Closed fractures Isolated shaft fractures Low energy Written informed consent by the parents Exclusion Criteria: Polytraumatized patients Cranial trauma or spinal cord injury Articular extension of the fracture History of femoral shaft fracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Acosta-Olivo, PhD
Organizational Affiliation
Universidad Autonoma de Nuevo Leon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario "Dr. José E. González". Universidad Autónoma de Nuevo León
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15469229
Citation
Flynn JM, Schwend RM. Management of pediatric femoral shaft fractures. J Am Acad Orthop Surg. 2004 Sep-Oct;12(5):347-59. doi: 10.5435/00124635-200409000-00009.
Results Reference
result
PubMed Identifier
16314721
Citation
Anglen JO, Choi L. Treatment options in pediatric femoral shaft fractures. J Orthop Trauma. 2005 Nov-Dec;19(10):724-33. doi: 10.1097/01.bot.0000192294.47047.99.
Results Reference
result
PubMed Identifier
7883924
Citation
Buehler KC, Thompson JD, Sponseller PD, Black BE, Buckley SL, Griffin PP. A prospective study of early spica casting outcomes in the treatment of femoral shaft fractures in children. J Pediatr Orthop. 1995 Jan-Feb;15(1):30-5. doi: 10.1097/01241398-199501000-00008.
Results Reference
result
PubMed Identifier
7560034
Citation
Hughes BF, Sponseller PD, Thompson JD. Pediatric femur fractures: effects of spica cast treatment on family and community. J Pediatr Orthop. 1995 Jul-Aug;15(4):457-60. doi: 10.1097/01241398-199507000-00009.
Results Reference
result
PubMed Identifier
9661858
Citation
Illgen R 2nd, Rodgers WB, Hresko MT, Waters PM, Zurakowski D, Kasser JR. Femur fractures in children: treatment with early sitting spica casting. J Pediatr Orthop. 1998 Jul-Aug;18(4):481-7.
Results Reference
result
PubMed Identifier
10739280
Citation
Ferguson J, Nicol RO. Early spica treatment of pediatric femoral shaft fractures. J Pediatr Orthop. 2000 Mar-Apr;20(2):189-92.
Results Reference
result
PubMed Identifier
16791068
Citation
Epps HR, Molenaar E, O'connor DP. Immediate single-leg spica cast for pediatric femoral diaphysis fractures. J Pediatr Orthop. 2006 Jul-Aug;26(4):491-6. doi: 10.1097/01.bpo.0000217724.08794.e4.
Results Reference
result

Learn more about this trial

Femoral Pediatric Fractures. Walking Spica Cast vs Synthetic Pants

We'll reach out to this number within 24 hrs