Pediatric ALL Clinical Trial
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
Verified date | March 2023 |
Source | Universidad Autonoma de Nuevo Leon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 31, 2023 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Months to 7 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Universitario "Dr. José E. González". Universidad Autónoma de Nuevo León | Monterrey | Nuevo León |
Lead Sponsor | Collaborator |
---|---|
Universidad Autonoma de Nuevo Leon |
Mexico,
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. — View 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: 10.1097/01241398-1995010 — View 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. — View Citation
Ferguson J, Nicol RO. Early spica treatment of pediatric femoral shaft fractures. J Pediatr Orthop. 2000 Mar-Apr;20(2):189-92. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Bone angulation | Evaluate and compare the angulation in all planes (varus, valgus, antecurvature or recurvatum) in two standard x-ray images (anteroposterior and lateral) | 42 days | |
Secondary | Bone shortening | The shortening it was measured in centimeters in two standard X-ray projections, and compared between the two groups | 42 days |
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