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Femoral Pediatric Fractures. Walking Spica Cast vs Synthetic Pants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04311866
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon

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.

Condition or disease Intervention/treatment Phase
Femoral Shaft Fracture Pediatric ALL Device: Synthetic pants Device: Spica cast Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 4, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: Spica cast
Standard practice for the management of the femoral shaft fractures.
Device: Spica cast
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.

Experimental: Synthetic fabric
Offer resistance, durability and low weight to treatment of femoral shaft fractures
Device: Synthetic pants
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.




Primary Outcome Measures :
  1. Bone consolidation [ Time Frame: 42 days ]
    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 :
  1. Bone angulation [ Time Frame: 42 days ]
    Evaluate and compare the angulation in all planes (varus, valgus, antecurvature or recurvatum) in two standard x-ray images (anteroposterior and lateral)

  2. Bone shortening [ Time Frame: 42 days ]
    The shortening it was measured in centimeters in two standard X-ray projections, and compared between the two groups



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Ages Eligible for Study:   18 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311866


Contacts
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Contact: Carlos Acosta-Olivo, PhD +528183476698 dr.carlosacosta@gmail.com
Contact: Rodolfo Morales-Ávalos, MD +528183476698 rodolfot59@hotmail.com

Locations
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Mexico
Hospital Universitario "Dr. José E. González". Universidad Autónoma de Nuevo León Recruiting
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
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Principal Investigator: Carlos Acosta-Olivo, PhD Universidad Autonoma de Nuevo Leon
Publications of Results:
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Responsible Party: Carlos A Acosta-Olivo, Clinical investigator, Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT04311866    
Other Study ID Numbers: OR19-00002
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon:
femoral pediatric shaft fractures
walking spica cast
synthetic pants
Additional relevant MeSH terms:
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Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries