Study Stopped
Lack of material for treatment of the patients
Femoral Pediatric Fractures. Walking Spica Cast vs Synthetic Pants
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2020
CompletedFirst Submitted
Initial submission to the registry
March 10, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2023
CompletedMarch 24, 2023
March 1, 2023
2.7 years
March 10, 2020
March 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
42 days
Secondary Outcomes (2)
Bone angulation
42 days
Bone shortening
42 days
Study Arms (2)
Spica cast
ACTIVE COMPARATORStandard practice for the management of the femoral shaft fractures.
Synthetic fabric
EXPERIMENTALOffer resistance, durability and low weight to treatment of femoral shaft fractures
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Polytraumatized patients
- Cranial trauma or spinal cord injury
- Articular extension of the fracture
- History of femoral shaft fracture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario "Dr. José E. González". Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460, Mexico
Related Publications (7)
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.
PMID: 15469229RESULTAnglen 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.
PMID: 16314721RESULTBuehler 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.
PMID: 7883924RESULTHughes 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.
PMID: 7560034RESULTIllgen 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.
PMID: 9661858RESULTFerguson J, Nicol RO. Early spica treatment of pediatric femoral shaft fractures. J Pediatr Orthop. 2000 Mar-Apr;20(2):189-92.
PMID: 10739280RESULTEpps 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.
PMID: 16791068RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Acosta-Olivo, PhD
Universidad Autonoma de Nuevo Leon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical investigator
Study Record Dates
First Submitted
March 10, 2020
First Posted
March 17, 2020
Study Start
January 4, 2020
Primary Completion
August 31, 2022
Study Completion
January 31, 2023
Last Updated
March 24, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share