Distal Radius FractureNCT03126175
Above-versus Below-elbow Casting for Conservative Treatment of Distal Radius Fractures
A study testing Below elbow immobilization and Above elbow immobilization in people with Distal Radius Fracture, run by Hospital Dr. Fernando Mauro Pires da Rocha at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Below elbow immobilization and Above elbow immobilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Apr 2018to 9 Dec 2019
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Open fractures.
- Vascular ou neurological compromise
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Municipal Dr. Fernando Mauro Pires da Rocha
São Paulo, São Paulo, 05835-005
About this study
Official title: Above-versus Below-elbow Casting for Conservative Treatment of Distal Radius Fractures: a Randomized Controlled Trial and Study Protocol.
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.
Read the 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
- Being tested
- Below elbow immobilization, Above elbow immobilization
- Keywords
- conservative treatment, treatment outcome
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Below elbow immobilizationDevice
Also called Plaster immobilization with elbow free (Below elbow)
20cm wide gypsum in the forearm cut to fit the thumb.
Above elbow immobilizationDevice
Also called Plater immobilization including elbow (Above elbow)
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.
| Study group | Role | What they receive |
|---|---|---|
| Above elbow immobilization | Active comparator | 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. Receives: Device: Above elbow immobilization |
| Below elbow immobilization | Experimental | 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. Receives: Device: Below elbow immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
maintenance of reduction by evaluation of radiographic parameters (wrist 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.
Measured: One, two, three, four, six, eight, twelve and twenty four weeks after fracture reduction(radiographs).
Secondary outcomes (4)
DASH questionnaire
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.
Measured: Two, six , eight, twelve and twenty four weeks
Patient Rated Wrist Evaluation (PRWE)
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.
Measured: Eight, twelve and twenty four weeks.
Pain (VAS - "Visual Analogue Pain Scale").
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.
Measured: one, two, three, four, six, eight, twelve and twenty four weeks after fracture reduction
Objective functional evaluation (goniometry and dynamometry)
The objective functional evaluation measurement will be made with protactor to measure wrist flexion, extension, ulnar deviation, radial deviation and pronosupination
Measured: Six, eight, twelve and twenty four weeks follow up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start2 Apr 2018
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Dr. Fernando Mauro Pires da Rocha
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Sponsor
- Investigators
- João Carlos Belloti, PhD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03126175
- Sponsor's protocol ID
- Above X below-elbow casting
- Status last verified
- Dec 2019
- First submitted
- 17 Apr 2017
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be made available through contact with the researcher.
Publications
Bunger C, Solund K, Rasmussen P. Early results after Colles' fracture: functional bracing in supination vs dorsal plaster immobilization. Arch Orthop Trauma Surg (1978). 1984;103(4):251-6. doi: 10.1007/BF00387330.
PubMed 6391415Bong MR, Egol KA, Leibman M, Koval KJ. A comparison of immediate postreduction splinting constructs for controlling initial displacement of fractures of the distal radius: a prospective randomized study of long-arm versus short-arm splinting. J Hand Surg Am. 2006 May-Jun;31(5):766-70. doi: 10.1016/j.jhsa.2006.01.016.
PubMed 16713840Stewart HD, Innes AR, Burke FD. Functional cast-bracing for Colles' fractures. A comparison between cast-bracing and conventional plaster casts. J Bone Joint Surg Br. 1984 Nov;66(5):749-53. doi: 10.1302/0301-620X.66B5.6389558.
PubMed 6389558Bohm ER, Bubbar V, Yong Hing K, Dzus A. Above and below-the-elbow plaster casts for distal forearm fractures in children. A randomized controlled trial. J Bone Joint Surg Am. 2006 Jan;88(1):1-8. doi: 10.2106/JBJS.E.00320.
PubMed 16391243Pool C. Colles's fracture. A prospective study of treatment. J Bone Joint Surg Br. 1973 Aug;55(3):540-4. No abstract available.
PubMed 4125714Sarmiento A, Pratt GW, Berry NC, Sinclair WF. Colles' fractures. Functional bracing in supination. J Bone Joint Surg Am. 1975 Apr;57(3):311-7.
PubMed 1123382Okamura A, de Mendonca GM, Raduan Neto J, de Moraes VY, Faloppa F, Belloti JC. Above-versus below-elbow casting for conservative treatment of distal radius fractures: a randomized controlled trial and study protocol. BMC Musculoskelet Disord. 2018 Mar 27;19(1):92. doi: 10.1186/s12891-018-2007-9.
PubMed 29587687
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Above-versus Below-elbow Casting for Conservative Treatment of Distal Radius Fractures: a Randomized Controlled Trial and Study Protocol.
- ClinicalTrials.gov ID
- NCT03126175
- Acronym / sponsor ID
- Above X below-elbow casting
- Conditions
- Distal Radius Fracture
- Keywords
- conservative treatment, treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Hospital Dr. Fernando Mauro Pires da RochaUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 24 Apr 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Above elbow immobilization | Active comparator | Device: Above elbow immobilizationAbove 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. |
| Below elbow immobilization | Experimental | Device: Below elbow immobilizationBelow 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Open fractures.
- Vascular ou neurological compromise
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 |
|---|---|---|
| Below elbow immobilizationAlso: Plaster immobilization with elbow free (Below elbow)20cm wide gypsum in the forearm cut to fit the thumb. | Device | Below elbow immobilization |
| Above elbow immobilizationAlso: Plater immobilization including elbow (Above elbow)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. | Device | Above elbow immobilization |
Primary outcome
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.
4 secondary outcomes
DASH questionnaire
Time frame: Two, six , eight, twelve and twenty four weeks
Patient Rated Wrist Evaluation (PRWE)
Time frame: Eight, twelve and twenty four weeks.
Pain (VAS - "Visual Analogue Pain Scale").
Time frame: one, two, three, four, six, eight, twelve and twenty four weeks after fracture reduction
Objective functional evaluation (goniometry and dynamometry)
Time frame: Six, eight, twelve and twenty four weeks follow up visit.
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 Dec 2019.
- Background: PubMed 6391415Bunger C, Solund K, Rasmussen P. Early results after Colles' fracture: functional bracing in supination vs dorsal plaster immobilization. Arch Orthop Trauma Surg (1978). 1984;103(4):251-6. doi: 10.1007/BF00387330.
- Background: PubMed 16713840Bong MR, Egol KA, Leibman M, Koval KJ. A comparison of immediate postreduction splinting constructs for controlling initial displacement of fractures of the distal radius: a prospective randomized study of long-arm versus short-arm splinting. J Hand Surg Am. 2006 May-Jun;31(5):766-70. doi: 10.1016/j.jhsa.2006.01.016.
- Background: PubMed 6389558Stewart HD, Innes AR, Burke FD. Functional cast-bracing for Colles' fractures. A comparison between cast-bracing and conventional plaster casts. J Bone Joint Surg Br. 1984 Nov;66(5):749-53. doi: 10.1302/0301-620X.66B5.6389558.
- Background: PubMed 16391243Bohm ER, Bubbar V, Yong Hing K, Dzus A. Above and below-the-elbow plaster casts for distal forearm fractures in children. A randomized controlled trial. J Bone Joint Surg Am. 2006 Jan;88(1):1-8. doi: 10.2106/JBJS.E.00320.
- Background: PubMed 4125714Pool C. Colles's fracture. A prospective study of treatment. J Bone Joint Surg Br. 1973 Aug;55(3):540-4. No abstract available.
- Results publication: PubMed 1123382Sarmiento A, Pratt GW, Berry NC, Sinclair WF. Colles' fractures. Functional bracing in supination. J Bone Joint Surg Am. 1975 Apr;57(3):311-7.
- Derived from this study: PubMed 29587687Okamura A, de Mendonca GM, Raduan Neto J, de Moraes VY, Faloppa F, Belloti JC. Above-versus below-elbow casting for conservative treatment of distal radius fractures: a randomized controlled trial and study protocol. BMC Musculoskelet Disord. 2018 Mar 27;19(1):92. doi: 10.1186/s12891-018-2007-9.
- Individual participant dataSharing planned: Yes. The data will be made available through contact with the researcher.
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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.
João Carlos Belloti, PhD study director
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Below elbow immobilization and Above elbow immobilization in people with Distal Radius Fracture, run by Hospital Dr. Fernando Mauro Pires da Rocha at 1 site in Brazil.
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 2 inclusion and 2 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 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03126175, which also lists 7 linked publications.
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 Dec 2019.