Short Forearm Casting Versus Below-elbow Splinting for Acute Immobilization of Distal Radius Fractures

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:

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 (Bong 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 Activities of Daily Living (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 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.)

Study Procedures

1. Study design, including the sequence and timing of study procedures (distinguish
research procedures from those that are part of routine care).

2. Study duration and number of study visits required of research participants.

3. Blinding, including justification for blinding or not blinding the trial, if applicable.

4. Justification of why participants will not receive routine care or will have current
therapy stopped.

5. Justification for inclusion of a placebo or non-treatment group.

6. Definition of treatment failure or participant removal criteria.

7. 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 Anteroposterior (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 (Bong 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 (Bong et al., 2006;
Stoffelen and Broos, 1998). Fractures meeting these criteria will undergo open
reduction, internal fixation (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.

Study Statistics

1. Primary outcome variable.

2. Secondary outcome variables.

3. Statistical plan including sample size justification and interim data analysis.

4. Early stopping rules.

Primary outcome variable: Maintenance of reduction

Secondary outcome variables: DASH scores, Radiographic parameters analyzed individually:
radial height, radial inclination, volar tilt

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.

Risks

1. Medical risks, listing all procedures, their major and minor risks and expected
frequency.

2. Steps taken to minimize the risks.

3. Plan for reporting unanticipated problems or study deviations.

4. Legal risks such as the risks that would be associated with breach of confidentiality.

5. 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.

Benefits

a. Description of the probable benefits for the participant and for society.

Below-elbow splinting is associated with decreased morbidity

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

Exclusion Criteria:

- Ipsilateral upper extremity injury

- Open injury or neurovascular compromise

- Greater than two attempts at reduction

- Presentation greater than 24 hours after injury