Short Forearm Casting Versus Below-elbow Splinting for Acute Immobilization of Distal Radius Fractures
Phase: NA
Conditions: Distal Radius Fracture
Sponsor: Johns Hopkins University

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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Short Forearm Casting Versus Below-elbow 
Splinting for Acute Immobilization of Distal 
Radius Fractures 
 
 
 
 
 
 
 
NCT02679066 
 
 
 
 
 
 
 
 
November 13, 2015 
 
 
 
 
 
 
 
 

 
 
JHMIRB eFormA  01 
Version 3 Dated:   06/2007 
 
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Date: 11/13/15 
Principal Investigator: Erik Hasenboehler 
Application Number: IRB00087273  
 
JHM IRB - eForm A – Protocol 
 
 
 
 Use the section headings to write the JHM IRB eForm A, inserting the appropriate material 
in each. If a section is not applicable, leave heading in and insert N/A. 
 When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at 
the top of JHM IRB eForm A. 
 
*************************************************************************************************** 
 
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research. 
 
Problem: 
There is no consensus regarding the need to immobilize the elbow in immediate immobilization of closed distal radius fractures 
post-reduction. Decreased functionality of the upper extremity is a notable morbidity associated with below-elbow splinting of 
distal radius fractures post-reduction. Few studies have provided evidence comparing sugar tong splinting versus short-arm 
casting as methods of immediate post-reduction immobilization. 
 
Research Hypothesis: 
There is no significant difference in maintenance of reduction, changes in radiographic parameters, or functional scores at two 
weeks in patients with distal radius fractures treated acutely with a short arm cast versus a sugar tong splint. 
 
Importance: 
The study will provide guidance regarding the need for short forearm cast immobilization versus sugar tong splinting in early 
maintenance of reduction of closed distal radius fractures, as well as functional effects of sugar tong splinting versus short 
forearm casting. 
 
 
2. 
Objectives (include all primary and secondary objectives) 
To determine the success of sugar tong splinting versus short arm casting for maintenance of reduction of closed distal 
radius fractures and to compare the functional outcomes in patients treated with sugar tong splinting versus short 
forearm casting as guidance for immediate post-reduction immobilization of these fractures. 
Primary objectives:   
 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research) 
 
 
Koval et al. randomized patients to long-arm versus short-arm splinting of post-reduction closed distal radius fractures 
and reported comparable maintenance of reduction with better functional scores in patients immobilized in a short-arm splint 
and thus recommended this method for immediate post-reduction immobilization of closed distal radius fractures (Koval et 
al. 2006). 
 
Grafstein et al. randomized 101 adult patients with closed distal radius fractures to sugar tong splinting versus above-
elbow circumferential casting versus above-elbow volar-dorsal splinting for immediate post-reduction immobilization and 
followed patients closely for 3 to 4 weeks. They reported no significant difference in loss of reduction, pain scores, range of 
motion, or ADLs between the three methods of immobilization and thus recommended treatment with any method with 
which the treating physician is most comfortable (Grafstein et al., 2010). 
 
Millet and Rushton randomized 99 women with closed distal radius fractures to below elbow plaster casts versus initial 
plaster casting followed by flexible casting to allow early joint range of motion and reported increased comfort, grip scores 

 
 
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and joint mobility in early treatment period without negative effects of early motion and thus concluded that early 
mobilization can be a beneficial treatment option (Millet and Rushton, 1995). 
 
Pool prospectively studied range of motion and radiographic parameters over a two year period in over 200 patients 
with Colles’ fractures treated with five different combinations of above- and below-elbow immobilization and concluded 
that while all patients went onto union and adequate function, those immobilized in above-elbow plaster lost some degree of 
supination. He found no benefit to above-elbow immobilization and recommended only below-elbow post-reduction 
immobilization (Pool, 1973). 
 
Sarmiento reviewed a case series of 44 patients with intra-articular distal radius fractures treated initially with an above-
elbow cast initially and transitioned early to a brace allowing elbow and wrist range of motion while restricting pronation-
supination and concluded that although fracture collapse did occur, functional results were good and the early mobilization 
reduced the stiffness and incapacitation associated with treatment of distal radius fractures (Sarmiento et al.) 
 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
b. Study duration and number of study visits required of research participants. 
c. Blinding, including justification for blinding or not blinding the trial, if applicable. 
d. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
e. Justification for inclusion of a placebo or non-treatment group. 
f. Definition of treatment failure or participant removal criteria. 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
 
Prospective, randomized, controlled trial 
 
One hundred twenty adult patients with closed fractures of the distal radius will be randomized to  below-elbow, sugar-
tong splinting versus short arm casting for immediate post-reduction immobilization.  
 
Residents will undergo a teaching session specifically for instruction on sugar tong splinting versus short arm casting. 
On-call resident will have access to an electronic folder containing randomization of patient to sugar tong splint versus bi-
valved short arm cast. All reductions will be performed under local hematoma block with 1% lidocaine and traction and less 
than three attempts at reduction. 
 
Patients will follow up at one, two and four weeks for repeat AP and lateral radiographs of the forearm to measure 
radiographic parameters to determine maintenance of reduction and will complete the Disabilities of the Arm, Shoulder and 
Hand Score (DASH) for functional scoring of the upper extremity at two weeks. 
 
Maintenance of reduction, as defined below, will be compared between splint constructs overall and in stable versus 
unstable fractures in each immobilization group. Specific changes in radial height, radial inclination and volar tilt as 
continuous variables will also be compared, as will DASH scores measuring functionality. 
 
Maintenance of reduction will be defined as: loss of reduction of < 2 mm radial height, < 5 degrees of radial inclination 
or < 10 degrees of volar tilt and/or < 2 mm intra-articular step off, in follow up radiographs as compared to immediate post-
reduction radiographs (Koval et al., 2006). 
 
Unstable fractures will be defined as, at injury: > 4 mm radial shortening, > 10 degrees dorsal tilt, radial-ulnar 
translation of radius > 2 mm, dorsal comminution > 50% diameter of radius, > 2mm intra-articular displacement (Koval et 
al., 2006; Stoffelen and Broos, 1998). Fractures meeting these criteria will undergo ORIF after reduction and at a later time. 
However, reduction parameters and maintenance of reduction will be evaluated and compared for both splinting techniques 
until ORIF. 
 
5. 
Inclusion/Exclusion Criteria 
 
 
Inclusion criteria: adult > 18 years of age, closed fracture, isolated injury, no prior injury to ipsilateral forearm, less than 
or equal to two attempts at reduction. 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed. 

 
 
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c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.  
 
Not Applicable 
 
7. 
Study Statistics 
a. Primary outcome variable. 
b. Secondary outcome variables. 
c. Statistical plan including sample size justification and interim data analysis. 
d. Early stopping rules. 
 
Primary outcome variable: Maintenance of reduction 
Secondary outcome variables: Radiographic parameters analyzed individually: radial height, radial 
inclination, volar tilt, DASH scores 
 
Statistical plan including sample size: Sample size was calculated based on standard deviations for the 
above-noted outcomes variables reported in the literature and selected a sample size based on the largest 
calculated sample size. This was increased from 167 to 200 to account for expected dropout. 
 
Early stopping rules: Less than 50% patient follow-up. 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
b. Steps taken to minimize the risks. 
c. Plan for reporting unanticipated problems or study deviations. 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
e. Financial risks to the participants. 
 
 No medical risks outside of standard of care. 
 Patients will be treated with standard of care. 
 Research committee of Department of Orthopaedic Surgery follows the progress of the 
project. 
 No legal risks. 
 No financial risks. 
 
9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
Below-elbow splinting is associated with decreased morbidity  
 
10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed bonus, 
and any proposed reductions or penalties for not completing the protocol. 
 
Not Applicable 
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
 
Not Applicable