Distal Radius FractureNCT05159310
Cast Vs Splint in Distal Radius Fractures
A study testing Cast vs Splint in people with Distal Radius Fracture, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This study will evaluate and compare the efficacy of 2 commonly-used methods of fracture immobilisation: (1) Fiberglass cast, and (2) Thermoplastic splint. Both these devices are externally applied and provide pain relief while immobilising the fracture in an acceptable position. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Cast vs Splint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 18 Feb 2022to Dec 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Closed DRF in patients > 60 years
- Presenting to HRMC within 10 days of injury
- Isolated injury
- With or without M\&R performed in EMD
- Declined surgical fixation after appropriate discussion
Who cannot join
- Wounds - skin tears, bad abrasions, open fracture
- Ulnar fracture > styloid
- Other MSK / non-MSK injuries
- Bilateral fractures
- Prior wrist fractures / wrist surgery
- Other upper limb conditions affecting function (e.g. CVA)
- Cognitive impairment
- Allergy to plaster or fiberglass
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Vanessa Wan, 67728237, vanessa_wan@nuhs.edu.sg
Soumen Das De
About this study
Official title: A Randomized Controlled Trial Comparing Clinical Outcomes of Casting Versus Splinting in Distal Radius Fractures in Patients 60 Years and Above
This study will evaluate and compare the efficacy of 2 commonly-used methods of fracture immobilisation: (1) Fiberglass cast, and (2) Thermoplastic splint. Both these devices are externally applied and provide pain relief while immobilising the fracture in an acceptable position. Casts and splints are both established devices in routine clinical use.
Read the detailed description
Casts and splints are both established methods of treating DRF. Casts have been traditionally the gold standard for non-operative care of fractures, but there are distinct disadvantages such as skin rash and pruritus, malodour, skin maceration and loosening as the initial swelling subsides. Casts require specialized tools for removal and they have to be reapplied by specialized staff if the casts become loose or wet. Splints have the advantage of being removable and therefore facilitate hygiene and provide a better fit because of the adjustable straps. Splints are theoretically less rigid and patient non-compliance because of the ease of removal may result in a greater likelihood of fracture displacement. However, it is known that fractures displace even in casts and the efficacy of casts at maintaining reduction over splints has not been established. Moreover, it has been clearly shown that the elderly patients have good functional outcomes that do not correlate with the position in which the fracture heals i.e. they tolerated a large degree of fracture malunion (Arora; Egol).
The primary goal of this study is to show that there is no difference in the final functional outcome between distal radius fractures treated non-operatively with splints and casts. The secondary goals are to demonstrate: (1) splinting results in greater patient comfort and acceptance; (2) there is no significant difference in final radiographic outcomes between DRF treated with casts and splints; and (3) there is no difference in clinical outcome at the 6-month and 12-month follow-up points.
This study is clinically important for several reasons. First, patients may be encouraged to use splints instead of casts if there is no difference in functional outcome and the former provide better comfort. Second, patients may not be required to present for long (>6-month) follow-ups if it can be shown that the clinical improvement plateaus at 6 months after injury. This is consistent with our aim to improve patients' overall quality of life after musculoskeletal injuries and forms a core component of functional ageing.
- Conditions
- Distal Radius Fracture
- Being tested
- Cast vs Splint
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cast vs SplintProcedure or surgery
Patients presenting with DRF will be screened by the attending consultant. The temporary backslab will be removed, X-rays will be obtained, and the attending consultant will discuss the treatment options. Patients who are planned for non-operative treatment and meet the inclusion criteria will be eligible for the study. The purpose and details of the study will be explained and informed consent will then be taken by the research coordinator (RC). The participants will then be randomized (using a block-randomization method) to either treatment by splint or cast.
| Study group | Role | What they receive |
|---|---|---|
| Cast | Other | Patients presenting with DRF will be screened by the attending consultant. The temporary backslab will be removed, X-rays will be obtained, and the attending consultant will discuss the treatment options. Patients who are planned for non-operative treatment and meet the inclusion criteria will be eligible for the study. The purpose and details of the study will be explained and informed consent will then be taken by the research coordinator (RC). The participants will then be randomized (using a block-randomization method) to either treatment by splint or cast. A research assistant will facilitate the randomisation process so that the RC and the treating physician remain blinded to treatment allocation. Receives: Procedure: Cast vs Splint |
| Splint | Other | Patients presenting with DRF will be screened by the attending consultant. The temporary backslab will be removed, X-rays will be obtained, and the attending consultant will discuss the treatment options. Patients who are planned for non-operative treatment and meet the inclusion criteria will be eligible for the study. The purpose and details of the study will be explained and informed consent will then be taken by the research coordinator (RC). The participants will then be randomized (using a block-randomization method) to either treatment by splint or cast. A research assistant will facilitate the randomisation process so that the RC and the treating physician remain blinded to treatment allocation. Receives: Procedure: Cast vs Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Splinting results in Quick Disabilities of Arm, Shoulder, Hand (QuickDASH) scores that are not poorer as compared to casting
The resultant score is reported on a scale of 0 to 100, where 0 represents no disability and 100 represents total disability.
Splinting in patients ≥60 years with distal radius fracture (DRF) results in 12-month QuickDASH scores that are significantly inferior compared to scores in patients treated in cast.
The alternate hypothesis is that splinting results in 12-month QuickDASH scores that are not significantly inferior compared to casting in this group of patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start18 Feb 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- The study methodology will be a non-inferiority randomized controlled trial (RCT). A non-inferiority design was selected because it is unlikely that splints are superior to casts with regards to the primary outcome - final functional outcome at 12 months. Both intention-to-treat and per-protocol analyses will be performed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soumen Das De, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159310
- Sponsor's protocol ID
- 2019/00510
- Other IDs
- 2019
- Status last verified
- Feb 2022
- First submitted
- 9 Nov 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Records for all participants, including all source documentation (containing evidence to study eligibility, history and physical findings, results of consultations etc) as well as IRB records and other regulatory documentation will be retained by the principal investigator via the following means: * Electronic records will be kept on an encrypted hard drive * Hardcopy data will be stored in a locked cabinets in the office of the principal investigator and accessed only by the principal investigator, co-investigators or study administrators.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Clinical Outcomes of Casting Versus Splinting in Distal Radius Fractures in Patients 60 Years and Above
- ClinicalTrials.gov ID
- NCT05159310
- Acronym / sponsor ID
- 2019/00510
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Dec 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.
This study will evaluate and compare the efficacy of 2 commonly-used methods of fracture immobilisation: (1) Fiberglass cast, and (2) Thermoplastic splint. Both these devices are externally applied and provide pain relief while immobilising the fracture in an acceptable position. Casts and splints are both established devices in routine clinical use.
Detailed description
Casts and splints are both established methods of treating DRF. Casts have been traditionally the gold standard for non-operative care of fractures, but there are distinct disadvantages such as skin rash and pruritus, malodour, skin maceration and loosening as the initial swelling subsides. Casts require specialized tools for removal and they have to be reapplied by specialized staff if the casts become loose or wet. Splints have the advantage of being removable and therefore facilitate hygiene and provide a better fit because of the adjustable straps. Splints are theoretically less rigid and patient non-compliance because of the ease of removal may result in a greater likelihood of fracture displacement. However, it is known that fractures displace even in casts and the efficacy of casts at maintaining reduction over splints has not been established. Moreover, it has been clearly shown that the elderly patients have good functional outcomes that do not correlate with the position in which the fracture heals i.e. they tolerated a large degree of fracture malunion (Arora; Egol).
The primary goal of this study is to show that there is no difference in the final functional outcome between distal radius fractures treated non-operatively with splints and casts. The secondary goals are to demonstrate: (1) splinting results in greater patient comfort and acceptance; (2) there is no significant difference in final radiographic outcomes between DRF treated with casts and splints; and (3) there is no difference in clinical outcome at the 6-month and 12-month follow-up points.
This study is clinically important for several reasons. First, patients may be encouraged to use splints instead of casts if there is no difference in functional outcome and the former provide better comfort. Second, patients may not be required to present for long (>6-month) follow-ups if it can be shown that the clinical improvement plateaus at 6 months after injury. This is consistent with our aim to improve patients' overall quality of life after musculoskeletal injuries and forms a core component of functional ageing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study methodology will be a non-inferiority randomized controlled trial (RCT). A non-inferiority design was selected because it is unlikely that splints are superior to casts with regards to the primary outcome - final functional outcome at 12 months. Both intention-to-treat and per-protocol analyses will be performed.
| Arm | Type | Receives |
|---|---|---|
| Cast | Other | Procedure: Cast vs SplintPatients presenting with DRF will be screened by the attending consultant. The temporary backslab will be removed, X-rays will be obtained, and the attending consultant will discuss the treatment options. Patients who are planned for non-operative treatment and meet the inclusion criteria will be eligible for the study. The purpose and details of the study will be explained and informed consent will then be taken by the research coordinator (RC). The participants will then be randomized (using a block-randomization method) to either treatment by splint or cast. A research assistant will facilitate the randomisation process so that the RC and the treating physician remain blinded to treatment allocation. |
| Splint | Other | Procedure: Cast vs SplintPatients presenting with DRF will be screened by the attending consultant. The temporary backslab will be removed, X-rays will be obtained, and the attending consultant will discuss the treatment options. Patients who are planned for non-operative treatment and meet the inclusion criteria will be eligible for the study. The purpose and details of the study will be explained and informed consent will then be taken by the research coordinator (RC). The participants will then be randomized (using a block-randomization method) to either treatment by splint or cast. A research assistant will facilitate the randomisation process so that the RC and the treating physician remain blinded to treatment allocation. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Closed DRF in patients > 60 years
- Presenting to HRMC within 10 days of injury
- Isolated injury
- With or without M\&R performed in EMD
- Declined surgical fixation after appropriate discussion
Key exclusion criteria (8 listed)
- Wounds - skin tears, bad abrasions, open fracture
- Ulnar fracture > styloid
- Other MSK / non-MSK injuries
- Bilateral fractures
- Prior wrist fractures / wrist surgery
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 |
|---|---|---|
| Cast vs SplintPatients presenting with DRF will be screened by the attending consultant. The temporary backslab will be removed, X-rays will be obtained, and the attending consultant will discuss the treatment options. Patients who are planned for non-operative treatment and meet the inclusion criteria will be eligible for the study. The purpose and details of the study will be explained and informed consent will then be taken by the research coordinator (RC). The participants will then be randomized (using a block-randomization method) to either treatment by splint or cast. | Procedure or surgery | Cast, Splint |
Primary outcome
Splinting results in Quick Disabilities of Arm, Shoulder, Hand (QuickDASH) scores that are not poorer as compared to casting
Time frame: 12 months
The resultant score is reported on a scale of 0 to 100, where 0 represents no disability and 100 represents total disability. Splinting in patients ≥60 years with distal radius fracture (DRF) results in 12-month QuickDASH scores that are significantly inferior compared to scores in patients treated in cast. The alternate hypothesis is that splinting results in 12-month QuickDASH scores that are not significantly inferior compared to casting in this group of patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: No. Records for all participants, including all source documentation (containing evidence to study eligibility, history and physical findings, results of consultations etc) as well as IRB records and other regulatory documentation will be retained by the principal investigator via the following means: * Electronic records will be kept on an encrypted hard drive * Hardcopy data will be stored in a locked cabinets in the office of the principal investigator and accessed only by the principal investigator, co-investigators or study administrators.
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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.
Soumen Das De principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cast vs Splint in people with Distal Radius Fracture, run by National University Hospital, Singapore at 1 site in Singapore.
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 8 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 9 Mar 2022. 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 Singapore. 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 Vanessa Wan (67728237, vanessa_wan@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Splinting results in Quick Disabilities of Arm, Shoulder, Hand (QuickDASH) scores that are not poorer as compared to casting (time frame: 12 months). 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 9 Mar 2022.