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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 > 5°, volar tilt - loss > 10°, ulnar variance - loss > 2 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.
- Secondary outcomes: self-reported function assessment Disabilities of the Arm, Shoulder and Hand questionnaire(DASH), 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 rates of loss of reduction following above or below elbow casting in pediatric population(10%).Our a priori hypothesis consider that adults will incur in a two-fold higher rate of loss of reduction. Considering this 20% difference and statistical power of 80%, a 48 patients sample size per group was calculated. Considering a 10% loss of follow up, a 53 patients sample per group was considered.
Benefits: Below elbow splinting is easier to apply, lower cost, more comfortable and permits better function for daily life activity.
Distal Radius Fracture
short radial splint, Short radial splint + elbow splint
Not yet recruiting
Hospital Dr. Fernando Mauro Pires da Rocha
Published on BioPortfolio: 2017-04-25T08:08:43-0400
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