Colles' FractureGitRaNCT02798614
Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures
A study testing 10-day cast in people with Colles' Fracture, run by Uppsala University Hospital.
Trial summary
The purpose of this study is to compare the radiographic and clinical outcomes after short versus conventional plaster cast fixation time in reduced distal radius fractures. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colles' Fracture
- What is being tested?
- 10-day cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Jan 2010
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Distal radius fracture with intact ulna (except for processus styloideus ulnae)
- Dorsal angulation 5-40 degrees
- Axial compression < 4 mm
- Intra articular step-off < 1 mm
- Low energy trauma
- Closed fracture
- Suitable for treatment with closed reduction and plaster cast fixation
Who cannot join
- Fracture older than 3 Days
- Previously fractured ipsi- or contralateral wrist
- Dementia
- Inflammatory joint disorder
About this study
Official title: A Comparison of Radiographic and Clinical Results After Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures
The purpose of this study is to compare the radiographic and clinical outcomes after short versus conventional plaster cast fixation time in reduced distal radius fractures.
Read the detailed description
Displaced distal radius fractures treated with closed reduction and plaster cast fixation are radiographed 10 days (range 8-13 days) after reduction and randomized to one of two study arms; immediate removal of plaster cast or continued fixation in plaster cast for another 3 weeks. Radiographic and Clinical outcome measurements at 1, 4 and 12 months
- Conditions
- Colles' Fracture
- Being tested
- 10-day cast
- Medical subject headings
- Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-day castDevice
Removal of plaster cast fixation 10 days after reduction
| Study group | Role | What they receive |
|---|---|---|
| 10-day cast | Active comparator | Removal of plaster cast 10 Days after reduction Receives: Device: 10-day cast |
| 1-month cast | No intervention | Removal of plaster cast 1 month after reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic displacement
Change in dorsal angulation, radial angulation and axial compression between follow-ups.
Measured: At admission, 10 days, 1 month and 12 months
Secondary outcomes (4)
Grip strength
Grip strength compared to uninjured side at 1, 4 and 12 months
Measured: Uninjured side. Injured side at 1, 4 , 12 months
Range of motion
Range of motion in dorsal extension, volar flexion, supination and pronation compared to uninjured side at 1, 4 and 12 months.
Measured: Uninjured side. Injured side at 1, 4 and 12 months
Assessment of pain intensity
Average pain over the last 24 h assessed with a visual analogue scale (VAS) at 10 days, 1, 4 and 12 months
Measured: 10 days, 1, 4 and 12 months
Assessment of functional outcome with three different functional assessment scores; 1,The modified de Bruijn wrist score 2, The modified Mayo wrist scoring chart 3, The Gartland and Werley Demerit wrist point system modified by Sarmiento.
The three functional assessment scores are composite outcome measures consisting of multiple measures (results to be reported as single values for each Group),
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 posted14 Jun 2016 (estimated)
- Study startSep 2002
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colles' 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
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Christersson, Uppsala University Hospital
- Investigators
- Albert Christersson, MD, Principal investigator, Department of Orthopaedics, University Hospital of Uppsala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798614
- Sponsor's protocol ID
- GR-0102
- Acronym
- GitRa
- Status last verified
- Jun 2016
- First submitted
- 1 Jun 2016
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Christersson A, Larsson S, Ostlund B, Sanden B. Radiographic results after plaster cast fixation for 10 days versus 1 month in reduced distal radius fractures: a prospective randomised study. J Orthop Surg Res. 2016 Nov 21;11(1):145. doi: 10.1186/s13018-016-0478-7.
PubMed 27871284
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Radiographic and Clinical Results After Short Versus Conventional Plaster Cast Fixation Time in Reduced Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT02798614
- Acronym / sponsor ID
- GitRa / GR-0102
- Conditions
- Colles' Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Jun 2016 (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.
The purpose of this study is to compare the radiographic and clinical outcomes after short versus conventional plaster cast fixation time in reduced distal radius fractures.
Detailed description
Displaced distal radius fractures treated with closed reduction and plaster cast fixation are radiographed 10 days (range 8-13 days) after reduction and randomized to one of two study arms; immediate removal of plaster cast or continued fixation in plaster cast for another 3 weeks. Radiographic and Clinical outcome measurements at 1, 4 and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10-day cast | Active comparator | Device: 10-day castRemoval of plaster cast 10 Days after reduction |
| 1-month cast | No intervention | –Removal of plaster cast 1 month after reduction |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Distal radius fracture with intact ulna (except for processus styloideus ulnae)
- Dorsal angulation 5-40 degrees
- Axial compression < 4 mm
- Intra articular step-off < 1 mm
- Low energy trauma
Key exclusion criteria (4 listed)
- Fracture older than 3 Days
- Previously fractured ipsi- or contralateral wrist
- Dementia
- Inflammatory joint disorder
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 |
|---|---|---|
| 10-day castRemoval of plaster cast fixation 10 days after reduction | Device | 10-day cast |
Primary outcome
Radiographic displacement
Time frame: At admission, 10 days, 1 month and 12 months
Change in dorsal angulation, radial angulation and axial compression between follow-ups.
4 secondary outcomes
Grip strength
Time frame: Uninjured side. Injured side at 1, 4 , 12 months
Range of motion
Time frame: Uninjured side. Injured side at 1, 4 and 12 months
Assessment of pain intensity
Time frame: 10 days, 1, 4 and 12 months
Assessment of functional outcome with three different functional assessment scores; 1,The modified de Bruijn wrist score 2, The modified Mayo wrist scoring chart 3, The Gartland and Werley Demerit wrist point system modified by Sarmiento.
Time frame: 12 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 16 Jun 2016.
- Derived from this study: PubMed 27871284Christersson A, Larsson S, Ostlund B, Sanden B. Radiographic results after plaster cast fixation for 10 days versus 1 month in reduced distal radius fractures: a prospective randomised study. J Orthop Surg Res. 2016 Nov 21;11(1):145. doi: 10.1186/s13018-016-0478-7.
- Individual participant dataSharing planned: No
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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.
Albert Christersson, MD principal investigator
Department of Orthopaedics, University Hospital of Uppsala
Questions about this trial
What is this clinical trial studying?
A study testing 10-day cast in people with Colles' Fracture, run by Uppsala University Hospital.
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 7 inclusion and 4 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 16 Jun 2016. 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?
Radiographic displacement (time frame: At admission, 10 days, 1 month and 12 months). 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 NCT02798614, which also lists 1 linked publication.
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 16 Jun 2016.