Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569199
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Pediatric Femur Fractures Functional Bracing vs Spica Casting - Outcomes and Cost Analysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Functional Bracing Versus Spica Casting for the Treatment of Pediatric Diaphyseal Femur Fractures A Randomized Prospective Study and Cost-effectiveness Analysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pediatric diaphyseal femur fractures that occur in children aged 6 months to 5 years old are traditionally treated with hip spica casting However recent studies suggest that functional bracing may offer clinical and financial benefits yet theres a lack of prospective trials comparing these two treatment methods This single-center randomized-control trial aims to assess subjective and objective clinical outcomes as well as financial aspects of functional bracing versus spica casting Functional bracing proposed as a potentially superior alternative may address caregiver challenges and reduce costs by avoiding operating room time and hospital admissions The study will evaluate fracture reduction time to union functional outcomes and caregiver satisfaction Additionally a comprehensive cost-effectiveness analysis will be conducted Ultimately this research aims to inform clinical decision-making regarding the optimal management of pediatric femur fractures considering both clinical effectiveness and economic implications
Detailed Description:
Pediatric diaphyseal femur fractures are a common orthopedic injury in children with about one-third occurring in patients under the age of five These fractures require effective management to promote optimal healing and functional recovery In the 6-month to 5-year-old age group diaphyseal femur fractures have traditionally been treated with a hip spica cast Application of a hip spica cast typically occurs in the operating room OR under general anesthesia given that patients must undergo prolonged sedation for cast application Caring for a child with a hip spica cast presents significant challenges for caregivers due to the casts cumbersome size and restricted mobility This makes routine activities such as daily hygiene toileting and skin surveillance difficult for caregivers An ecological study performed by Kocher et al found that spica casting places a greater burden on family functioning than medical treatment in children with serious chronic medical conditions including diabetes renal failure and juvenile rheumatoid arthritis1
Kramer et al have recently proposed the use of functional bracing as an equally effective alternative to traditional hip spica casting for the treatment of pediatric diaphyseal femur fractures In their study they found no differences in the correction and maintenance of fracture alignment time to union and functional outcomes2 The use of a prefabricated and adjustable functional brace was suggested to be better tolerated by patients and their parents as the open design allows for improved hygiene ease of cleaning toileting skin surveillance and improved positional movement
From a cost-effectiveness analysis perspective it has been inferred that the overall cost of functional bracing compared to spica casting is lower as it can be applied in the emergency department without the need for a general anesthetic or operating room time Furthermore we hypothesize that functional bracing will also decrease visits to orthopedic clinics for cast-related issues which will further decrease the overall costs associated with the treatment of pediatric diaphyseal fractures with a functional brace when compared to a hip spica cast Having said this no comprehensive cost-effectiveness analysis studies have been performed to our knowledge and there is minimal literature comparing functional bracing versus spica casting for the treatment of pediatric diaphyseal femur fractures
This proposed study aims to address this gap by conducting a randomized prospective study comparing functional bracing and spica casting for the treatment of pediatric diaphyseal femur fractures by evaluating maintenance of fracture reduction time to union leg-length functional outcomes complications parentcaregiver satisfaction with the treatment as well as performing a supplemental comprehensive cost-effectiveness analysis
Kramer et al have recently proposed the use of functional bracing as an equally effective alternative to traditional hip spica casting for the treatment of pediatric diaphyseal femur fractures In their study they found no differences in the correction and maintenance of fracture alignment time to union and functional outcomes2 The use of a prefabricated and adjustable functional brace was suggested to be better tolerated by patients and their parents as the open design allows for improved hygiene ease of cleaning toileting skin surveillance and improved positional movement
From a cost-effectiveness analysis perspective it has been inferred that the overall cost of functional bracing compared to spica casting is lower as it can be applied in the emergency department without the need for a general anesthetic or operating room time Furthermore we hypothesize that functional bracing will also decrease visits to orthopedic clinics for cast-related issues which will further decrease the overall costs associated with the treatment of pediatric diaphyseal fractures with a functional brace when compared to a hip spica cast Having said this no comprehensive cost-effectiveness analysis studies have been performed to our knowledge and there is minimal literature comparing functional bracing versus spica casting for the treatment of pediatric diaphyseal femur fractures
This proposed study aims to address this gap by conducting a randomized prospective study comparing functional bracing and spica casting for the treatment of pediatric diaphyseal femur fractures by evaluating maintenance of fracture reduction time to union leg-length functional outcomes complications parentcaregiver satisfaction with the treatment as well as performing a supplemental comprehensive cost-effectiveness analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None