Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures - Full Text View

Sponsored by:	The Hospital for Sick Children
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00610220

Purpose

The study will compare the effectiveness of a prefabricated wrist splint with thermoplast reinforcements versus a short arm cast in skeletally immature children.

The hypothesis is that the commercially available wrist splint is at least as effective as traditional casting with respect to recovery of physical function.

Condition	Intervention	Phase
Distal Radius Fractures	Device: Fiberglass short arm cast Device: Prefabricated wrist splint	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial of Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

Modified performance Activities Scale for Kids (ASKp) score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in Angulation and/or displacement [ Time Frame: 1 and 4 weeks ] [ Designated as safety issue: No ]
Pain [ Time Frame: At time of injury and once a week for 4 weeks ] [ Designated as safety issue: No ]
Duration of immobilization device [ Time Frame: 1 and 4 week follow-up visits ] [ Designated as safety issue: No ]
Grip Strength [ Time Frame: 6 week follow-up visit ] [ Designated as safety issue: No ]
Range of Motion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Time to return to full painless baseline activities [ Time Frame: Time frame determined by outcome ] [ Designated as safety issue: No ]

Estimated Enrollment:	76
Study Start Date:	January 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Device: Fiberglass short arm cast Cast will be applied for a 4-week period
2: Experimental	Device: Prefabricated wrist splint Splint will be applied for a 4-week period

Detailed Description:

Acceptability angulated wrist bone fractures in children carry an excellent long-term prognosis because of the unique capacity of skeletally immature bones to heal via remodeling. Their management varies widely and there is virtually no scientific evidence supporting one treatment modality over another. Importantly, the most common treatment modality of cast application for four to six weeks is associated with many inconveniences. There are commercially available wrist splints that offer a more convenient alternative. Wrist splints likely have comparable immobilization and symptom relief, while simultaneously allowing for easier bathing and less reliance on subspeciality care. Preliminary adult evidence suggests that, in a comparable adult fracture, splinting may offer a safe alternative to casting, with earlier resumption of the usual activities. However, this treatment modality needs to be compared to the traditional casting management in the pediatric population before it can be recommended for clinical practice.

This study will be the first to challenge the current practice of routine casting and compare it to a commercially available wrist splint with respect to recovery of physical function in children with acceptably angulated wrist fractures. In addition, standardized treatment of these fractures with a splint may be associated with lower morbidity, reduced use of health care resources, and have the potential for cost savings.

This study will compare, in skeletally immature children, the functional outcomes that result from treatment with a prefabricated wrist splint versus a short arm cast in acceptably angulated distal radius fractures. Secondly, the cost-effectiveness of the splint relative to the cast will be evaluated.

Eligibility

Ages Eligible for Study:	5 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Skeletally immature children.
Children must have a bone age of ≥ 5 years of age.
Less than or equal to 15° angulation in the sagital plane and ≤ 0.5 cm displacement in the frontal plane.

Therefore, all skeletally immature children ≥ 5 years and with a bone age of ≤ 11 years who present to the ED of HSC with acute distal metaphyseal

radius +/- ulnar fractures that meet criteria for acceptable angulation and displacement will be eligible for enrollment.

Exclusion Criteria:

Age ≥ 4 years
The following diagnoses of distal radius fracture: buckle fracture, growth plate fractures of any kind, distal radius metaphyseal fractures with greater than 15° of angulation in the sagital plane and/or more than 0.5 cm of displacement in the frontal plane.
All open fractures which require a surgical debridement.
All children at risk for pathological fractures such as those with congenital or acquired generalized bony disease. Stricter immobilization and a different prognosis may be applicable to this population.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610220

Contacts

Contact: Kathy Boutis, MD

(416) 813-8982

kleanthi.boutis@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada
Contact: Kathy Boutis, MD (416) 813-8982 kleanthi.boutis@sickkids.ca
Contact: Andrew R. Willan, PhD (416) 813-2166 andrew.willan@sickkids.ca
Sub-Investigator: Andrew R. Willan, PhD
Sub-Investigator: Andrew Howard, MSc, MD
Sub-Investigator: Paul Babyn, MD
Sub-Investigator: Ron Goeree, BA, MA

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator:

Kathy Boutis, MD

The Hospital for Sick Children

More Information

No publications provided

Responsible Party:	The Hospital for Sick Children ( Kathy Boutis/Principal Investigator )
Study ID Numbers:	1000010377
Study First Received:	January 24, 2008
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00610220 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

pediatrics
wrist fractures
casting
wrist splint

Study placed in the following topic categories:

Fractures, Bone
Wounds and Injuries
Forearm Injuries

Disorders of Environmental Origin
Radius Fractures
Arm Injuries

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries
Forearm Injuries

Disorders of Environmental Origin
Radius Fractures
Arm Injuries

ClinicalTrials.gov processed this record on July 06, 2009