Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of material for treatment of the patients
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Femoral Shaft Fracture | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spica cast | Device | — | UNRESOLVED |
| Synthetic pants | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Spica cast
- description
- Standard practice for the management of the femoral shaft fractures.
- interventionNames
- Device: Spica cast
- type
- EXPERIMENTAL
- label
- Synthetic fabric
- description
- Offer resistance, durability and low weight to treatment of femoral shaft fractures
- interventionNames
- Device: Synthetic pants
Primary outcomes (1)
- measure
- Bone consolidation
- timeFrame
- 42 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
- Maximum age
- 7 Years
Show eligibility criteria text
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
References
Publications (7)
- RESULTFlynn 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 15469229
- RESULTAnglen 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 16314721
- RESULTBuehler 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 7883924
- RESULTHughes 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 7560034
- RESULTIllgen 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 9661858
- RESULTFerguson J, Nicol RO. Early spica treatment of pediatric femoral shaft fractures. J Pediatr Orthop. 2000 Mar-Apr;20(2):189-92. PMID 10739280
- RESULTEpps 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 16791068