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Distal Radius FractureNCT02286661

Short-Arm Casting Effective in Type A2 Fractures in the Distal Radius

A study testing Casting (long arm) and Casting (short arm) in people with Distal Radius Fracture, run by Mashhad University of Medical Sciences.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Distal radius fracture (DRF) is among the most common fractures of the long bones, which comprise one sixth of all fractures. Due to its high prevalence, effect on patients' everyday life, and cost on national health resources, its proper management is very important. Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Distal Radius Fracture
What is being tested?
Casting (long arm) and Casting (short arm)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Sep 2010to Feb 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Older than 20 years
  • Type A2 according to the AO classification
  • Closed distal radial physis
  • Initial radiographic evidence of extra articular DRF
  • With at least one non-comminuted cortex

Who cannot join

  • Fractures with dorsal angulations of more than 20 degrees
  • Radial shortening of more than 10 millimeters
  • Extensive cortical comminution as unstable fractures
  • Patients with unstable fractures
  • Existence of multiple fractures or open fracture in the affected limb or other limbs
  • Cerebral palsy
Show all 10Show fewer
  • Paresthesia of the affected limb due to the pervious cerebro-vascular accidents
  • Previous severe deformity of the affected limb diabetes
  • Severe osteoporosis
  • Less than two consecutive follow-up visits

About this study

Official title: Outcome Assessment in the Treatment of Type A2 Fractures of the Distal Radius by Short Arm Cast Versus Long Arm Cast

Distal radius fracture (DRF) is among the most common fractures of the long bones, which comprise one sixth of all fractures. Due to its high prevalence, effect on patients' everyday life, and cost on national health resources, its proper management is very important. The investigators performed this prospective randomized clinical trial on 100 patients with DRFs. 50 patients were treated in each group either by short or long arm cast. Patients were visited during the 6th and 18th weeks after the reduction regarding loss of reduction and possible complications.

Read the detailed description

After obtaining institutional review board (IRB) approval, the investigators performed this prospective randomized clinical trial on patients with DRFs admitted in three medical centers from September 2010 to February 2011. Patients signed the consent form prior to enrolment. the investigators included the patients older than 20 years with closed distal radial physis and initial radiographic evidence of extra articular DRF with at least one non-comminuted cortex. All fractures were type A2 according to the AO classification. The investigators considered fractures with dorsal angulations of more than 20 degrees, radial shortening of more than 10 millimeters and extensive cortical comminution as unstable fractures. Patients with unstable fractures were excluded from this study. Other exclusion criteria were the existence of multiple fractures or open fracture in the affected limb or other limbs, cerebral palsy, paresthesia of the affected limb due to the pervious cerebro-vascular accidents, previous severe deformity of the affected limb, diabetes and severe osteoporosis. Th investigators also excluded patients who had less than two consecutive follow-up visits. All eligible patients signed the informed consent. One hundred four patients were eligible to be included in this study; The investigators excluded four patients, as they did not tend to participate in the process of follow-up. The investigators divided 100 remaining patients into reduction with SAC or reduction with LAC groups based on the table of random numbers.

The investigators performed plain anterior posterior (AP) and lateral radiograph of the affected wrist in all patients initially to determine fracture severity. Based on the radial height, radial inclination and palmar tilt in initial radiograph, patients were divided into two groups. There were no significant differences between the groups regarding the pre-operative fracture characteristics. Most of the fractures were reduced under local anesthesia but general anesthesia or regional block were performed for selected patients. The technique of reduction was by slight traction and counter-traction and manipulation methods. In SAC group, the investigators positioned the forearm in neutral rotation and volar-ulnar deviation. The investigators applied The cast from the metacarpophalangeal joints dorsally and proximal palmar crease volarly, extending to one inch distal to antecubital fossa anteriorly and the olecranon posteriorly. Three points and inter osseous molding was performed. The investigators did the same technique in the LAC group. Additionally, The investigators positioned the elbow in 90 degrees of flexion and extended the plaster to the middle of the arm.

The investigators performed lateral and AP radiographs of the forearm after reduction and casting and measured the radiographic parameters (radial height, radial inclination and dorsal angulations). In all cases, anatomical reduction was considered a successful reduction. Immediately after reduction, patients started active motion of the fingers and tried to elevate the limb to the level at or above the heart. The investigators examined all patients regarding compartment syndrome. Besides, they informed the patients about compartment symptoms too. Many patients were treated in an ambulatory setting and discharged after six hours observation, but some patients were hospitalized and then discharged within two days after reduction. The investigators checked the alignment radiographically during the second week after the reduction. In the suspicious cases for the loss of reduction, comparison was done with contra-lateral wrist radiography. The investigators performed repeated reduction for those cases with unacceptable displacement. The reduction was unacceptable if there was more than five millimeters of displacement or more than five degrees of angulations. The surgeons converted LAC to SAC during the fourth week and removed casts after six weeks. The patients started active and passive motion of the wrist, elbow and fingers as the cast was removed. Patients referred to the clinic during the 6th and 18th weeks after the reduction. AP and lateral plain radiography of the wrist were performed in each visit. The investigators evaluated the patients regarding loss of reduction, malunion, nonunion, carpal tunnel syndrome, compartment syndrome, limitation in elbow and forearm range of motion (ROM), number of wounds and blisters, patient's satisfaction and stability of the distal radioulnar joint. In cases with unstable distal radioulnar joint during the 6th week visit, casting was continued for three more weeks in forearm supination position. In these cases forearm ROM was examined during the 9th and 18th weeks. The investigators considered the instability of distal radioulnar joint (DRUJ) when there was tenderness on DRUJ and pain on its mobility. For assessing the forearm pronation and supination, the patient tried to range the forearm by holding a pen in the fist with the elbow at 90 degrees flexed and adducted. Limits of ROM were abnormal if there was more than 10 degrees of difference comparing with the unaffected side.

The investigators scored patients' satisfaction by using the Visual Analog Scale (VAS) at 18th week follow-up. VAS consists of ten-point from zero (extremely dissatisfied) to 10 (extremely satisfied). The independent-Samples t-test and chi square test were used for statistical analysis when appropriate. The level of significance was set at P<0.05.

Being tested
Casting (long arm), Casting (short arm)
Medical subject headings
Wrist Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Casting (long arm)Procedure or surgery

    Casting using plaster of paris after closed reduction of distal radius fracture

  • Casting (short arm)Procedure or surgery

Study groups in NCT02286661
Study groupRoleWhat they receive
Short Arm CastActive comparatorShort arm cast below the elbow
Receives: Procedure: Casting (short arm)
Long Arm CastActive comparatorLong arm cast above the elbow
Receives: Procedure: Casting (long arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Range of Motion

    Elbow flexion-extension and forearm supination-pronation

    Measured: 18 weeks after closed reduction

Secondary outcomes (1)
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Distal radioulnar joint instability

    Measured: 18 weeks after closed reduction and casting

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2014 (estimated)
  2. Study startSep 2010
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02286661
Sponsor's protocol ID
T1631
Status last verified
Nov 2014
First submitted
4 Nov 2014
Last updated
10 Nov 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Casting (long arm) and Casting (short arm) in people with Distal Radius Fracture, run by Mashhad University of Medical Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Range of Motion (time frame: 18 weeks after closed reduction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2014.

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