Lack of material for treatment of the patients
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
Sponsor study identifier
interventional
0
1 country
1
Study Start
January 4, 2020
Actual (reported)Primary Completion
August 31, 2022
Actual (reported)Study Completion
January 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 4, 2020
Actual (reported)March 10, 2020
Actual (reported)March 17, 2020
Actual (reported)August 31, 2022
Actual (reported)January 31, 2023
Actual (reported)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
Bone angulation
42 days
Bone shortening
42 days
Standard practice for the management of the femoral shaft fractures.
Offer resistance, durability and low weight to treatment of femoral shaft fractures
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.
Hospital Universitario "Dr. José E. González". Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460, Mexico
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.
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.
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.
Carlos Acosta-Olivo, PhD
Universidad Autonoma de Nuevo Leon
0 participants (actual enrollment reported by the registry).
First Submitted
March 10, 2020
First Posted
March 17, 2020
Study Start
January 4, 2020
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
Ferguson J, Nicol RO. Early spica treatment of pediatric femoral shaft fractures. J Pediatr Orthop. 2000 Mar-Apr;20(2):189-92.
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.
Primary Completion
August 31, 2022
Actual (reported)Study Completion
January 31, 2023
Actual (reported)Last Updated
March 24, 2023
Record last verified: 2023-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: