Distal Radius Fracture Clinical Trial
Official title:
Above-versus Below-elbow Casting for Conservative Treatment of Distal Radius Fractures: a Randomized Controlled Trial and Study Protocol.
For the non-surgical treatment of distal radius fractures in adults a variety cast options are available, including or not the elbow joint. The literature is inconclusive regarding the need to immobilize the elbow joint after reduction of the distal radius fracture.This study was undertaken to evaluate the best method of immobilization between the above and below-elbow cast groups at the end of 6 months of follow-up.
To determine the best method of immobilization ( below elbow versus above elbow splint) in
patients with distal radius fractures at the end of 6 months of follow-up:
- Type of study: Prospective, randomized and controlled trial.
- Patient recruitment: Adults attended in emergency room with closed acute displaced
distal radius fracture will be reduced under general venous anesthesia with fluoroscopic
control.
Displaced and reducible fractures (after venous anesthesia) will be included if one of these
conditions is present: Radial height - loss > 2 mm , radial Inclination- loss > 4°, dorsal
tilt - > 10°, ulnar variance - loss > 3 mm, intra-articular step off or gap - > 2mm . The
contralateral side will be used as a reference.
The eligible participants will be informed about the nature and purpose of the study by
reading the "Informed Consent Term" after ageeement, patients will included in the trial and
randomized.
- Maintenace of reduction will be defined as the maintenance of the parameters listed
above.
- Patients with above elbow immobilization will remain for 4 weeks with splint followed by
2 weeks of below elbow immobilization. The immobilization will be removed with 6 weeks.
- The primary outcome is: maintenance of reduction by evaluation of radiographic
parameters (wrist radiographs) at one, two, three, four, six, eight, twelve and twenty
four weeks after fracture reduction and self-reported function assessment Disabilities
of the Arm, Shoulder and Hand questionnaire(DASH).
- Secondary outcomes:Patient Rated Wrist Evaluation- PRWE. Pain (VAS - "Visual Analogue
Pain Scale"). Objective functional evaluation (goniometry and dynamometry) and rate of
complications and failures.
- Sample Size calculation was calculated based on data derived from one recent randomized
clinical trial on the subject. We considered as relevant differences on DASH scores
(clinically relevant) when scores are greater than 10 points and standard deviation 15
points. To detect this difference (Student T-test) and statistical power of 95% resulted
in a 58 patient sample size per group. We considered an extra 10% for balancing follow
up losses. Thus, our inclusion target will be 64 patients per group. We considered the
test as bicaudal.
Benefits: Below elbow splinting is easier to apply, lower cost, more comfortable and permits
better function for daily life activity.
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