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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
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Hospital Dr. Fernando Mauro Pires da Rocha

Brief 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.

Condition or disease Intervention/treatment Phase
Distal Radius Fracture Device: Below elbow immobilization Device: Above elbow immobilization Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults with growth plate closured, both gender, with closed acute displaced distal radius fracture (up to 1 week), associated or not with the ulnar styloid fractures with no other fractures, which may be closed reduced after intravenous anesthesia. No previous fractures to the ipsilateral or contralateral forearm.
  • Displaced and reducible fractures (after venous anesthesia) classified by AO as type A2, A3, C1, C2 and C3.

Exclusion Criteria:

  • Open fractures.
  • Vascular ou neurological compromise

Information from the National Library of Medicine

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


Locations
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Brazil
Hospital Municipal Dr. Fernando Mauro Pires da Rocha
São Paulo, SP, Brazil, 05835-005
Sponsors and Collaborators
Hospital Dr. Fernando Mauro Pires da Rocha
Federal University of São Paulo
Investigators
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Study Director: João Carlos Belloti, PhD Federal University of São Paulo

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital Dr. Fernando Mauro Pires da Rocha
ClinicalTrials.gov Identifier: NCT03126175     History of Changes
Other Study ID Numbers: Above X below-elbow casting
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be made available through contact with the researcher.
Supporting Materials: Study Protocol
Time Frame: The data of study protocol is already available. doi: 10.1186/s12891-018-2007-9
Access Criteria: open
URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5870077/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Dr. Fernando Mauro Pires da Rocha:
conservative treatment, treatment outcome
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries