Above-versus Below-elbow Casting for Conservative Treatment of Distal Radius Fractures
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|ClinicalTrials.gov Identifier: NCT03126175|
Recruitment Status : Completed
First Posted : April 24, 2017
Last Update Posted : December 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Distal Radius Fracture||Device: Below elbow immobilization Device: Above elbow immobilization||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||open label|
|Official Title:||Above-versus Below-elbow Casting for Conservative Treatment of Distal Radius Fractures: a Randomized Controlled Trial and Study Protocol.|
|Actual Study Start Date :||April 2, 2018|
|Actual Primary Completion Date :||December 9, 2019|
|Actual Study Completion Date :||December 9, 2019|
Active Comparator: Above elbow immobilization
Above elbow immobililization with short radial splint that will be performed with 20cm wide gypsum cut to fit the thumb. The splint will be applied to the radial aspect of the wrist covering the volar and dorsal portion of the radius to the elbow. Additional splint with a 15cm width splint on the ulnar aspect of the forearm that begins at the middle of the forearm and extends into the armpit.
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.
Other Name: Plater immobilization including elbow (Above elbow)
Experimental: Below elbow immobilization
Below elbow immobilization with exclusively short radial splint that will be performed with 20cm wide gypsum cut to fit the thumb. The splint will be applied to the radial aspect of the wrist covering the volar and dorsal portion of the radius to the elbow.
Device: Below elbow immobilization
20cm wide gypsum in the forearm cut to fit the thumb.
Other Name: Plaster immobilization with elbow free (Below elbow)
- maintenance of reduction by evaluation of radiographic parameters (wrist radiographs). [ Time Frame: One, two, three, four, six, eight, twelve and twenty four weeks after fracture reduction(radiographs). ]Posteroanterior and lateral x-rays of the wrist to measure radiographic parameters to determine maintenance of reduction will be done every follow up visit. Measurements of the alignment will be made on the radiographs with a marker, straight edge, and protractor. The radiographic measurement technique will be standardized, and repeatability testing demonstrated by a complete blinded assessor. All radiographs will be reviewed by one of the four authors.
- DASH questionnaire [ Time Frame: Two, six , eight, twelve and twenty four weeks ]The DASH questionnaire was developed as an instrument for patients with upper-extremity injuries. The survey contains 37 questions related to the function of the hand, wrist, elbow, and shoulder.
- Patient Rated Wrist Evaluation (PRWE) [ Time Frame: Eight, twelve and twenty four weeks. ]The PRWE contains 15 items that are specific to determine the degree of musculoskeletal disability related to the wrist. Both are validated tools of upper extremity function.
- Pain (VAS - "Visual Analogue Pain Scale"). [ Time Frame: one, two, three, four, six, eight, twelve and twenty four weeks after fracture reduction ]Visual Analogue Pain Scale(VAS). It is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Pain in VAS is a continuous scale comprised of a horizontal line with 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]). The participants are asked to report pain intensity in the last 24 hours. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 100mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.
- Objective functional evaluation (goniometry and dynamometry) [ Time Frame: Six, eight, twelve and twenty four weeks follow up visit. ]The objective functional evaluation measurement will be made with protactor to measure wrist flexion, extension, ulnar deviation, radial deviation and pronosupination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126175
|Hospital Municipal Dr. Fernando Mauro Pires da Rocha|
|São Paulo, SP, Brazil, 05835-005|
|Study Director:||João Carlos Belloti, PhD||Federal University of São Paulo|