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.
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.
- Conditions
- Distal Radius Fracture
- 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 group | Role | What they receive |
|---|---|---|
| Short Arm Cast | Active comparator | Short arm cast below the elbow Receives: Procedure: Casting (short arm) |
| Long Arm Cast | Active comparator | Long 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.
Range of Motion
Elbow flexion-extension and forearm supination-pronation
Measured: 18 weeks after closed reduction
Secondary outcomes (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.
- First posted10 Nov 2014 (estimated)
- Study startSep 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Reza Kachooei, Mashhad University of Medical Sciences
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Assessment in the Treatment of Type A2 Fractures of the Distal Radius by Short Arm Cast Versus Long Arm Cast
- ClinicalTrials.gov ID
- NCT02286661
- Acronym / sponsor ID
- T1631
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Arm Cast | Active comparator | Procedure: Casting (short arm)Short arm cast below the elbow |
| Long Arm Cast | Active comparator | Procedure: Casting (long arm)Long arm cast above the elbow |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Casting (long arm)Casting using plaster of paris after closed reduction of distal radius fracture | Procedure or surgery | Long Arm Cast |
| Casting (short arm) | Procedure or surgery | Short Arm Cast |
Primary outcome
Range of Motion
Time frame: 18 weeks after closed reduction
Elbow flexion-extension and forearm supination-pronation
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 18 weeks after closed reduction and casting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.