Closed Fracture of Lower End of RadiusNCT06209242
Cast Immobilization Versus Percutaneous Pinning for Fracture of Radius in an Elderly Patient
A study testing Percutaneous pinning and Cast immobilization in people with Closed Fracture of Lower End of Radius, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial summary
Distal radius fractures, particularly in elderly individuals, are a common problem associated with increasing age and hormonal changes. The choice of treatment, such as cast immobilization or percutaneous pinning, plays a crucial role in achieving optimal functional outcomes and facilitating a return to normal… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Closed Fracture of Lower End of Radius
- What is being tested?
- Percutaneous pinning and Cast immobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2021to 1 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
- aged >60 years
- primary distal end radius fracture type AO23-A2 or AO23-A3
Who cannot join
- multiple trauma
- onset > 2 weeks
- systemic diseases such as RA
- steroid user
- contraindication for LA
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Queen Savang Vadhana Memorial hospital
Chon Buri, Sriracha, 20110
About this study
Official title: Cast Immobilization Versus Percutaneous Pinning in Local Anesthesia for Extra-articular Fracture of Distal End Radius in an Elderly Patient: a Prospective Randomized Controlled Study
Distal radius fractures, particularly in elderly individuals, are a common problem associated with increasing age and hormonal changes. The choice of treatment, such as cast immobilization or percutaneous pinning, plays a crucial role in achieving optimal functional outcomes and facilitating a return to normal activities. This study aimed to compare the radiological and clinical outcomes of cast immobilization and percutaneous pinning in elderly patients with distal radius fractures.
Read the detailed description
Background: Distal radius fractures, particularly in elderly individuals, are a common problem associated with increasing age and hormonal changes. The choice of treatment, such as cast immobilization or percutaneous pinning, plays a crucial role in achieving optimal functional outcomes and facilitating a return to normal activities. This study aimed to compare the radiological and clinical outcomes of cast immobilization and percutaneous pinning in elderly patients with distal radius fractures.
Methods: This prospective randomized controlled trial enrolled participants aged over 60 years with AO23-A2 or AO23-A3 distal radius fractures and no contraindications for local anesthesia. The participants were randomly assigned to either the cast immobilization or percutaneous pinning group. Follow-up was conducted for 3 months, during which radiological outcomes and clinical outcomes were assessed. Radiological parameters included radial angulation, while clinical outcomes were evaluated using the Disability of Arm, Shoulder, and Hand (DASH) score, range of motion, and grip strength. Additionally, data on complications and pain levels measured using the Visual Analog Scale (VAS) were collected for the percutaneous pinning group under local anesthesia.
- Conditions
- Closed Fracture of Lower End of Radius
- Being tested
- Percutaneous pinning, Cast immobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous pinningProcedure or surgery
Using k- wire percutaneous pinning with local anesthesia with one-day surgery protocol
Cast immobilizationProcedure or surgery
Using sugar tong slab and then replace to short arm casting within 1 week
| Study group | Role | What they receive |
|---|---|---|
| Cast immobilization | Experimental | Using cast immobilization with sugar tong and short arm splinting Receives: Procedure: Cast immobilization |
| Percutaneous pinning | Experimental | Using k-wire percutaneous pinning Receives: Procedure: Percutaneous pinning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological parameters
Radial angulation, radial inclination, ulnar deviation, radial height
Measured: 1 wk , 4 wk , 3 months
Secondary outcomes (2)
DASH score
Functional outcome
Measured: 1 month, 3 months
Hand function
Range of motion, grip strength
Measured: 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Aug 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed Fracture of Lower End of RadiusStudies 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
- Sequential
- Model description
- This prospective randomized controlled trial enrolled participants aged over 60 years with AO23-A2 or AO23-A3 distal radius fractures and no contraindications for local anesthesia. The participants were randomly assigned to either the cast immobilization or percutaneous pinning group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teerasit Punprasitwech, MD, Principal investigator, QSMVH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209242
- Sponsor's protocol ID
- 027/2564
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data was save inform of excel, sheets and SPSS
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cast Immobilization Versus Percutaneous Pinning in Local Anesthesia for Extra-articular Fracture of Distal End Radius in an Elderly Patient: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06209242
- Acronym / sponsor ID
- 027/2564
- Conditions
- Closed Fracture of Lower End of Radius
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 17 Jan 2024 (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.
Distal radius fractures, particularly in elderly individuals, are a common problem associated with increasing age and hormonal changes. The choice of treatment, such as cast immobilization or percutaneous pinning, plays a crucial role in achieving optimal functional outcomes and facilitating a return to normal activities. This study aimed to compare the radiological and clinical outcomes of cast immobilization and percutaneous pinning in elderly patients with distal radius fractures.
Detailed description
Background: Distal radius fractures, particularly in elderly individuals, are a common problem associated with increasing age and hormonal changes. The choice of treatment, such as cast immobilization or percutaneous pinning, plays a crucial role in achieving optimal functional outcomes and facilitating a return to normal activities. This study aimed to compare the radiological and clinical outcomes of cast immobilization and percutaneous pinning in elderly patients with distal radius fractures.
Methods: This prospective randomized controlled trial enrolled participants aged over 60 years with AO23-A2 or AO23-A3 distal radius fractures and no contraindications for local anesthesia. The participants were randomly assigned to either the cast immobilization or percutaneous pinning group. Follow-up was conducted for 3 months, during which radiological outcomes and clinical outcomes were assessed. Radiological parameters included radial angulation, while clinical outcomes were evaluated using the Disability of Arm, Shoulder, and Hand (DASH) score, range of motion, and grip strength. Additionally, data on complications and pain levels measured using the Visual Analog Scale (VAS) were collected for the percutaneous pinning group under local anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This prospective randomized controlled trial enrolled participants aged over 60 years with AO23-A2 or AO23-A3 distal radius fractures and no contraindications for local anesthesia. The participants were randomly assigned to either the cast immobilization or percutaneous pinning group.
| Arm | Type | Receives |
|---|---|---|
| Cast immobilization | Experimental | Procedure: Cast immobilizationUsing cast immobilization with sugar tong and short arm splinting |
| Percutaneous pinning | Experimental | Procedure: Percutaneous pinningUsing k-wire percutaneous pinning |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged >60 years
- primary distal end radius fracture type AO23-A2 or AO23-A3
Key exclusion criteria (5 listed)
- multiple trauma
- onset > 2 weeks
- systemic diseases such as RA
- steroid user
- contraindication for LA
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 |
|---|---|---|
| Percutaneous pinningUsing k- wire percutaneous pinning with local anesthesia with one-day surgery protocol | Procedure or surgery | Percutaneous pinning |
| Cast immobilizationUsing sugar tong slab and then replace to short arm casting within 1 week | Procedure or surgery | Cast immobilization |
Primary outcome
Radiological parameters
Time frame: 1 wk , 4 wk , 3 months
Radial angulation, radial inclination, ulnar deviation, radial height
2 secondary outcomes
DASH score
Time frame: 1 month, 3 months
Hand function
Time frame: 1 month, 3 months
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 17 Jan 2024.
- Individual participant dataSharing planned: No. Data was save inform of excel, sheets and SPSS
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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.
Teerasit Punprasitwech, MD principal investigator
QSMVH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous pinning and Cast immobilization in people with Closed Fracture of Lower End of Radius, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
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 5 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 17 Jan 2024. 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 Thailand. 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?
Radiological parameters (time frame: 1 wk , 4 wk , 3 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 17 Jan 2024.