Distal Radius Interventions for Fracture Treatment

Part of paid clinical trials in Phoenix, Arizona.

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Study ID: NCT05131685
Status: Recruiting

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Conditions

Fracture Distal Radius

Eligibility Criteria

Sex: ALL
Age: 4 Years - 10 Years
Healthy Volunteers: Not accepted

Interventions

Reduction — PROCEDURE
closed reduction under conscious sedation followed by casting
Immobilization — PROCEDURE
immobilization in cast without reduction

Study Details

This protocol describes a multicenter, prospective randomized superiority trial comparing functional outcomes between children treated with sedated reduction versus no formal reduction.

Key Dates

Start date: Apr 9, 2023
Status verified: Aug 2024
Primary completion: Oct 31, 2027
Completion: Aug 31, 2028

Study Design

Enrollment: 334 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Non-sedated Immobilization
Immobilization in a cast without reduction
Active Comparator: Formal Reduction
closed reduction under conscious sedation followed by casting

Primary Outcome Measure

functional and patient reported outcomes [ Time Frame: 1 year follow-up ]

Central Contacts

Jamie Burgess, PhD
312-227-6531
[email protected]
Candace Young, MS
(312) 227-6427
[email protected]

Locations (25)

Facility	City	State	ZIP	Site coordinators
Phoenix Children's Hospital	Phoenix	Arizona	85016	Kajol Majhail [email protected] (602) 933- 2712 Mohan Belthur, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Los Angeles	Los Angeles	California	90027	Sam Wimmer [email protected] Rachel Goldstein, MD (PRINCIPAL_INVESTIGATOR)
University of California- Los Angeles Medical Center	Los Angeles	California	90095	Johnathan You [email protected] Maurcio Silva, MD (PRINCIPAL_INVESTIGATOR)
Nemours Children's Hospital	Wilmington	Delaware	19803	Susan Dubowy, PA-C [email protected] Jeanne Franzone, MD (PRINCIPAL_INVESTIGATOR)
Niklaus Children's Hospital	Miami	Florida	33155	Stephanie Uriguen [email protected] Monica Payares, MD (PRINCIPAL_INVESTIGATOR)
Riley Children's	Indianapolis	Indiana	46202	Molly Moore [email protected] Erika Daley, MD (PRINCIPAL_INVESTIGATOR)
Riley Children's Hospital	Indianapolis	Indiana	46202	Molly Moore [email protected] Erika Daley, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins Hospital	Baltimore	Maryland	21287	Gabrielle Reichard [email protected] R. Jay Lee, MD (PRINCIPAL_INVESTIGATOR)
Boston Children's Hospital	Boston	Massachusetts	02115	Maya Fajardo [email protected] Collin May, MD (PRINCIPAL_INVESTIGATOR)
TRIA Health Partners	Minneapolis	Minnesota	55102	Mairead Vanni [email protected] Deb Bohn, MD (PRINCIPAL_INVESTIGATOR)
Gillette Children's Specialty Healthcare	Saint Paul	Minnesota	55101	Jamie Price [email protected] (651) 325-2315 Walter Truong, MD (PRINCIPAL_INVESTIGATOR) Andrew Georgiadis, MD (PRINCIPAL_INVESTIGATOR)
University of Mississippi Medical Center	Jackson	Mississippi	39216	Sandra Powe [email protected] Kellie Leitch, MD (PRINCIPAL_INVESTIGATOR)
University Hospital- Rutgers	New Brunswick	New Jersey	07103	Charlene Wetterstrand [email protected] Neil Kaushal, MD (PRINCIPAL_INVESTIGATOR)
University of New Mexico - Carrie Tingley	Albuquerque	New Mexico	87106	Leorrie Watson [email protected] Selina Silva, MD (PRINCIPAL_INVESTIGATOR)
Hospital of Special Surgery	New York	New York	10021	Pari Palandjian [email protected] Emily Dodwell, MD (PRINCIPAL_INVESTIGATOR)
New York University-Langone Health	New York	New York	10016	Micaela Tomaro [email protected] Karim Masrouha, MD (PRINCIPAL_INVESTIGATOR)
University of Rochester Medical Center	Rochester	New York	14642	Ashley Owens [email protected] Natasha O'Malley, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical Center	The Bronx	New York	10467	Leila Alvandi [email protected] Jacob Schulz, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	27599	Malvika Choudhari [email protected] (919) 966-9718 Stuart Leighton Mitchell, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati's Children's Hospital	Cincinnati	Ohio	452229	Karen Brtko Wendy Ramalingam, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Rainbow Babies & Children	Cleveland	Ohio	44106	Abigail Schlosser, RN BSN Christina Hardesty (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science University	Portland	Oregon	97239	Zewdi Cass [email protected] Matthew Halsey, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Divya Talwar [email protected] Ted Ganley, MD (PRINCIPAL_INVESTIGATOR) Apurva Shah, MD (SUB_INVESTIGATOR) Todd Lawrence, MD (SUB_INVESTIGATOR)
Texas Scottish Rite Hospital for Children	Dallas	Texas	75219	Chinelo Onubogu [email protected] Corey Gill, MD (PRINCIPAL_INVESTIGATOR) Christine Ho, MD (SUB_INVESTIGATOR) Jaysson Brooks, MD (SUB_INVESTIGATOR) Henry Ellis, MD (SUB_INVESTIGATOR)
Texas Children's Hospital	Houston	Texas	77030	Justine Kasay [email protected] Dorothy Harris-Beauvais, MD (PRINCIPAL_INVESTIGATOR)

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