Distal Radius FractureNCT05012345
Distal Radial Fractures in Adult Patients: 4 Weeks Versus 6 Weeks of Cast Immobilisation Following Closed Reduction.
A study testing Below Elbow cast in people with Distal Radius Fracture, run by Cork University Hospital at 1 site in Ireland.
Trial summary
A single-blinded randomized controlled trial is initiated. Four weeks of plaster cast immobilization is compared with six weeks of plaster cast immobilization in adult patients with adequately reduced distal radius fracture. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Below Elbow cast
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 20 Aug 2021to 1 Jul 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary displaced distal radius fracture
- age older than 18 years.
- Adequate closed reduction of the distal radius fracture according to Lidström criteria for misalignment.
Who cannot join
- Ipsilateral fractures proximal to the distal radius.
- Pre-existent abnormalities or functional deficits of the fractured wrist that influences the patient reported function of the wrist.
- Open fractures.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Cork University Hospital
Cork, T12DFK4
Hany Elbardesy, M.Sc., FRCS, +353892106657, elbardecy@i.com
James Harty, Professor, jamesharty@me.com
About this study
Official title: Distal Radial Fractures in Adult Patients: 4 Weeks Versus 6 Weeks of Cast Immobilization Following Closed Reduction.
A single-blinded randomized controlled trial is initiated. Four weeks of plaster cast immobilization is compared with six weeks of plaster cast immobilization in adult patients with adequately reduced distal radius fracture. Primary outcome parameters are functional outcomes measured with the Patient Rated Wrist Evaluation after 6 months of follow-up (FU). Secondary outcomes are Disability of Arm, Shoulder and Hand Score after 6 months and one year, 36-Item Short-Form Health Survey after 6 months and one year, functional outcome earlier in Follow up (6 weeks, 12 weeks, 6 months, and one year), range of motion, pain level, and complications: number of re-interventions, secondary displacement, delayed and non-union.
Read the detailed description
This study will be conducted as a prospective single-blinded randomized clinical trial in a level one trauma center serving the southeast of Ireland. In this study, 4 weeks of plaster immobilization will be compared with 6 weeks of plaster immobilization. The methods of this study protocol are comparable to a previously published article comparing 3 weeks of cast immobilization to 5 weeks of cast immobilization in adult patients with non-displaced distal radius fractures. Patients will be treated in a lower arm cast in a neutral position. Following immobilization, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised, and exercises to train wrist function will be given. As extra structured advice programs may cause no extra benefit for the patient, this was not generally prescribed. However, during follow-up visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected.
Patients will only be able to participate if closed reduction of the DRF is adequate. The indication for reduction will be set, using the Lidström criteria for misalignment. Patients will only be able to participate in this study if reduction is performed successfully. Successful reduction will be classified as radial shortening <3 mm, dorsal tilt <10° or intra-articular step-off <2 mm, according to the guidelines of the American Academy of Orthopaedic Surgeons.
After providing informed consent, eligible patients will be randomised after 2 weeks when the fracture has proven to be stable. An independent research assistant will perform concealed permuted block randomisation using a computer-generated randomisation schedule after stratification for fracture type, gender, and age. Allocation will be at random in four blocks. To prevent bias, stratification by age (younger and older than 60 years) and gender will be performed . Randomisation between another 2 or 4 weeks cast immobilisation will be performed to complete a total of 4 and 6 weeks of cast immobilisation, respectively. Randomisation will occur after informed consent.
cast removal, number of re-interventions, delayed and non-unions and Complex regional Pain Syndrome (CRPS).
At each FU visit, the research coordinator or research assistant will ascertain patient status (ie, secondary interventions, adverse events/complications, deaths) and will verify the information within medical records. All adverse events will be addressed to the principal investigator. At each FU visit, the patients will be asked to indicate the actual pain level on a VAS. Patients will also be asked if they have any complaints of their treatment and will be asked if they are currently treated by a physical therapist. At each visit from 8 weeks onwards, the range of motion of the wrist will be measured using a goniometer, according to the reference values for joint range of motion published by the American Academy of Orthopaedic Surgeons. In addition, patients will be asked to complete the questionnaires relating to disability. Plain X-rays of the wrist will be made at the time of presentation in the hospital (ED), after 1 and 2 weeks, 4 or 6 weeks, and at the follow-up visit after 8 weeks, 3 months, 6 months, and one year. The X-ray at 6 months will be taken in order to determine the grade of degenerative joint changes. The time to define the presence of a delayed- or non-union will be at 3 or 6 months. The sample size of 44 patients per treatment group is calculated with a power (1-β) of 80% and a type I error (α) of 5%, allowing for 10% dropout. In this study, we decided to include 50 patients per treatment group. To allow a 10% dropout in this study, in total 100 patients will be included.
- Conditions
- Distal Radius Fracture
- Being tested
- Below Elbow cast
- Keywords
- distal radius fracture, 4 weeks, 6 weeks.
- 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 castProcedure or surgery
below-elbow cast ( 4 or 6 weeks )
| Study group | Role | What they receive |
|---|---|---|
| 4 Weeks cast immobilisation | Experimental | Patients with fracture distal radius ( indicated for conservative treatment) will stay in a below-elbow cast for 4 weeks. Following immobilisation, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised and exercises to train wrist function will be given. As extra structured advice programmes may cause no extra benefit for the patient, this was not generally prescribed. However, during FU visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected. Receives: Procedure: Below Elbow cast |
| 6 Weeks cast immobilisation | Experimental | Patients with fracture distal radius ( indicated for conservative treatment) will stay in a below-elbow cast for 6 weeks. Following immobilisation, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised and exercises to train wrist function will be given. As extra structured advice programmes may cause no extra benefit for the patient, this was not generally prescribed. However, during FU visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected. Receives: Procedure: Below Elbow cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Rated Wrist Evaluation (PRWE)
is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living
Measured: One year
Patient Rated Wrist Evaluation (PRWE)
is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living
Measured: Three months
Patient Rated Wrist Evaluation (PRWE)
is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living
Measured: Six months
Quick Disability of Arm and Shoulder (DASH)
is a self-report questionnaire that assesses a person's perceived level of incapacity pertaining to disability of the arm, shoulder, and hand and is based on the 30-item DASH instrument, where each item on the QuickDASH was retained relative to key concepts of upper-limb functioning as well as the selection of the highest ranked items from the original according to their psychometric properties
Measured: 3 months
Quick Disability of Arm and Shoulder (DASH)
is a self-report questionnaire that assesses a person's perceived level of incapacity pertaining to disability of the arm, shoulder, and hand and is based on the 30-item DASH instrument, where each item on the QuickDASH was retained relative to key concepts of upper-limb functioning as well as the selection of the highest ranked items from the original according to their psychometric properties
Measured: 6 months
Quick Disability of Arm and Shoulder (DASH)
is a self-report questionnaire that assesses a person's perceived level of incapacity pertaining to disability of the arm, shoulder, and hand and is based on the 30-item DASH instrument, where each item on the QuickDASH was retained relative to key concepts of upper-limb functioning as well as the selection of the highest ranked items from the original according to their psychometric properties
Measured: One year
Secondary outcomes (4)
Range of Movement
Flexion, Extension, radial and ulnar deviation
Measured: 3 months
Range of Movement
Flexion, Extension, radial and ulnar deviation
Measured: 6 months
Range of Movement
Flexion, Extension, radial and ulnar deviation
Measured: one year
Complications
Stiffness, delayed and non-union and complex regional pain syndrome (CRPS).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start20 Aug 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- A prospective single-blinded randomised clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cork University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Elbardesy, Cork University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012345
- Sponsor's protocol ID
- ECM 3 (vvv) 09/02/2021
- Status last verified
- Aug 2021
- First submitted
- 24 Jul 2021
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ringbaek T, Folkmann T, Neumann S, Frolund L, Mortensen J, Ulrik CS, El Ali HH. Effect of deep inspiration on impulse oscillometry responses to methacholine in healthy adults. Front Allergy. 2026 Jun 1;7:1816138. doi: 10.3389/falgy.2026.1816138. eCollection 2026.
PubMed 42306178Elbardesy H, Yousaf MI, Reidy D, Ansari MI, Harty J. Distal radial fractures in adults: 4 versus 6 weeks of cast immobilisation after closed reduction, a randomised controlled trial. Eur J Orthop Surg Traumatol. 2023 Dec;33(8):3469-3474. doi: 10.1007/s00590-023-03574-2. Epub 2023 May 16.
PubMed 37191887
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Radial Fractures in Adult Patients: 4 Weeks Versus 6 Weeks of Cast Immobilization Following Closed Reduction.
- ClinicalTrials.gov ID
- NCT05012345
- Acronym / sponsor ID
- ECM 3 (vvv) 09/02/2021
- Conditions
- Distal Radius Fracture
- Keywords
- distal radius fracture, 4 weeks, 6 weeks.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cork University HospitalUniversity, hospital or other
- Study start
- 20 Aug 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 19 Aug 2021 (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.
A single-blinded randomized controlled trial is initiated. Four weeks of plaster cast immobilization is compared with six weeks of plaster cast immobilization in adult patients with adequately reduced distal radius fracture. Primary outcome parameters are functional outcomes measured with the Patient Rated Wrist Evaluation after 6 months of follow-up (FU). Secondary outcomes are Disability of Arm, Shoulder and Hand Score after 6 months and one year, 36-Item Short-Form Health Survey after 6 months and one year, functional outcome earlier in Follow up (6 weeks, 12 weeks, 6 months, and one year), range of motion, pain level, and complications: number of re-interventions, secondary displacement, delayed and non-union.
Detailed description
This study will be conducted as a prospective single-blinded randomized clinical trial in a level one trauma center serving the southeast of Ireland. In this study, 4 weeks of plaster immobilization will be compared with 6 weeks of plaster immobilization. The methods of this study protocol are comparable to a previously published article comparing 3 weeks of cast immobilization to 5 weeks of cast immobilization in adult patients with non-displaced distal radius fractures. Patients will be treated in a lower arm cast in a neutral position. Following immobilization, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised, and exercises to train wrist function will be given. As extra structured advice programs may cause no extra benefit for the patient, this was not generally prescribed. However, during follow-up visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected.
Patients will only be able to participate if closed reduction of the DRF is adequate. The indication for reduction will be set, using the Lidström criteria for misalignment. Patients will only be able to participate in this study if reduction is performed successfully. Successful reduction will be classified as radial shortening <3 mm, dorsal tilt <10° or intra-articular step-off <2 mm, according to the guidelines of the American Academy of Orthopaedic Surgeons.
After providing informed consent, eligible patients will be randomised after 2 weeks when the fracture has proven to be stable. An independent research assistant will perform concealed permuted block randomisation using a computer-generated randomisation schedule after stratification for fracture type, gender, and age. Allocation will be at random in four blocks. To prevent bias, stratification by age (younger and older than 60 years) and gender will be performed . Randomisation between another 2 or 4 weeks cast immobilisation will be performed to complete a total of 4 and 6 weeks of cast immobilisation, respectively. Randomisation will occur after informed consent.
cast removal, number of re-interventions, delayed and non-unions and Complex regional Pain Syndrome (CRPS).
At each FU visit, the research coordinator or research assistant will ascertain patient status (ie, secondary interventions, adverse events/complications, deaths) and will verify the information within medical records. All adverse events will be addressed to the principal investigator. At each FU visit, the patients will be asked to indicate the actual pain level on a VAS. Patients will also be asked if they have any complaints of their treatment and will be asked if they are currently treated by a physical therapist. At each visit from 8 weeks onwards, the range of motion of the wrist will be measured using a goniometer, according to the reference values for joint range of motion published by the American Academy of Orthopaedic Surgeons. In addition, patients will be asked to complete the questionnaires relating to disability. Plain X-rays of the wrist will be made at the time of presentation in the hospital (ED), after 1 and 2 weeks, 4 or 6 weeks, and at the follow-up visit after 8 weeks, 3 months, 6 months, and one year. The X-ray at 6 months will be taken in order to determine the grade of degenerative joint changes. The time to define the presence of a delayed- or non-union will be at 3 or 6 months. The sample size of 44 patients per treatment group is calculated with a power (1-β) of 80% and a type I error (α) of 5%, allowing for 10% dropout. In this study, we decided to include 50 patients per treatment group. To allow a 10% dropout in this study, in total 100 patients will be included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective single-blinded randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| 4 Weeks cast immobilisation | Experimental | Procedure: Below Elbow castPatients with fracture distal radius ( indicated for conservative treatment) will stay in a below-elbow cast for 4 weeks. Following immobilisation, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised and exercises to train wrist function will be given. As extra structured advice programmes may cause no extra benefit for the patient, this was not generally prescribed. However, during FU visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected. |
| 6 Weeks cast immobilisation | Experimental | Procedure: Below Elbow castPatients with fracture distal radius ( indicated for conservative treatment) will stay in a below-elbow cast for 6 weeks. Following immobilisation, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised and exercises to train wrist function will be given. As extra structured advice programmes may cause no extra benefit for the patient, this was not generally prescribed. However, during FU visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary displaced distal radius fracture
- age older than 18 years.
- Adequate closed reduction of the distal radius fracture according to Lidström criteria for misalignment.
Key exclusion criteria (3 listed)
- Ipsilateral fractures proximal to the distal radius.
- Pre-existent abnormalities or functional deficits of the fractured wrist that influences the patient reported function of the wrist.
- Open fractures.
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 castbelow-elbow cast ( 4 or 6 weeks ) | Procedure or surgery | 4 Weeks cast immobilisation, 6 Weeks cast immobilisation |
Primary outcome
Patient Rated Wrist Evaluation (PRWE)
Time frame: One year
is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living
Patient Rated Wrist Evaluation (PRWE)
Time frame: Three months
is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living
Patient Rated Wrist Evaluation (PRWE)
Time frame: Six months
is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living
Quick Disability of Arm and Shoulder (DASH)
Time frame: 3 months
is a self-report questionnaire that assesses a person's perceived level of incapacity pertaining to disability of the arm, shoulder, and hand and is based on the 30-item DASH instrument, where each item on the QuickDASH was retained relative to key concepts of upper-limb functioning as well as the selection of the highest ranked items from the original according to their psychometric properties
Quick Disability of Arm and Shoulder (DASH)
Time frame: 6 months
is a self-report questionnaire that assesses a person's perceived level of incapacity pertaining to disability of the arm, shoulder, and hand and is based on the 30-item DASH instrument, where each item on the QuickDASH was retained relative to key concepts of upper-limb functioning as well as the selection of the highest ranked items from the original according to their psychometric properties
Quick Disability of Arm and Shoulder (DASH)
Time frame: One year
is a self-report questionnaire that assesses a person's perceived level of incapacity pertaining to disability of the arm, shoulder, and hand and is based on the 30-item DASH instrument, where each item on the QuickDASH was retained relative to key concepts of upper-limb functioning as well as the selection of the highest ranked items from the original according to their psychometric properties
4 secondary outcomes
Range of Movement
Time frame: 3 months
Range of Movement
Time frame: 6 months
Range of Movement
Time frame: one year
Complications
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- Derived from this study: PubMed 42306178Ringbaek T, Folkmann T, Neumann S, Frolund L, Mortensen J, Ulrik CS, El Ali HH. Effect of deep inspiration on impulse oscillometry responses to methacholine in healthy adults. Front Allergy. 2026 Jun 1;7:1816138. doi: 10.3389/falgy.2026.1816138. eCollection 2026.
- Derived from this study: PubMed 37191887Elbardesy H, Yousaf MI, Reidy D, Ansari MI, Harty J. Distal radial fractures in adults: 4 versus 6 weeks of cast immobilisation after closed reduction, a randomised controlled trial. Eur J Orthop Surg Traumatol. 2023 Dec;33(8):3469-3474. doi: 10.1007/s00590-023-03574-2. Epub 2023 May 16.
- Individual participant dataSharing planned: Yes
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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.
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 cast in people with Distal Radius Fracture, run by Cork University Hospital at 1 site in Ireland.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Aug 2021. 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Harty, Professor (00353214921383, jamesharty@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Rated Wrist Evaluation (PRWE) (time frame: One year). The study lists 6 primary outcomes in all. 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 NCT05012345, which also lists 2 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 19 Aug 2021.