NCT03126175

Above-versus Below-elbow Casting for Conservative Treatment of Distal Radius Fractures

Above-versus Below-elbow Casting for Conservative Treatment of Distal Radius Fractures: a Randomized Controlled Trial and Study Protocol.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Hospital Dr. Fernando Mauro Pires da Rocha · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Distal Radius Fracture

Interventions

Type	Name	Description
DEVICE	Below elbow immobilization	20cm wide gypsum in the forearm cut to fit the thumb.
DEVICE	Above elbow immobilization	20cm wide gypsum in the forearm cut to fit the thumb associated a elbow splint made with a 15cm width on the ulnar aspect of the forearm that begins at the middle of the forearm and extends into the armpit.

Timeline

• Start date: 2018-04-02
• Primary completion: 2019-12-09
• Completion: 2019-12-09
• First posted: 2017-04-24
• Last updated: 2019-12-10

Locations

1 site across 1 country: Brazil