Fracture of the Distal RadiusVOCALNCT01268397
Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly
A study testing open reduction and internal fixation with a volar plate and closed reduction and plaster treatment in people with Fracture of the Distal Radius and Wrist Fracture, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Fracture of the Distal Radius, Wrist Fracture
- What is being tested?
- open reduction and internal fixation with a volar plate and closed reduction and plaster treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2009to 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).
Who cannot join
- Previous displaced fracture of the distal radius.
- Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ<5), psychiatric illness, alcohol abuse).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly. A Randomized Comparison Between Operative Fixation and Plaster Cast Treatment.
The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.
Read the detailed description
We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.
- Conditions
- Fracture of the Distal Radius, Wrist Fracture
- Being tested
- open reduction and internal fixation with a volar plate, closed reduction and plaster treatment
- Keywords
- elderly, wrist fracture, fracture of the distal radius, volar plate, plaster cast
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open reduction and internal fixation with a volar plateProcedure or surgery
Also called plate: Königsee or Aculoc from Swemac, Sweden
flexor carpi radialis approach, open reduction, fixed-angle volar plate, plaster cast 2 weeks at the surgeon's discretion
closed reduction and plaster treatmentProcedure or surgery
closed reduction, below elbow plaster cast, semicircular for 5 week
| Study group | Role | What they receive |
|---|---|---|
| ORIF | Active comparator | Open reduction and internal fixation with a volar plate Receives: Procedure: open reduction and internal fixation with a volar plate |
| plaster treatment | Active comparator | Closed reduction and plaster treatment Receives: Procedure: closed reduction and plaster treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-perceived disability measured by the PRWE and DASH questionnaires
Measured: one year after wrist fracture
Secondary outcomes (1)
impairments (grip strength and range of motion compared with the uninjured wrist)
Measured: one year after wrist fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2018
- Study completionDec 2019 (estimated)
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 Fracture of the Distal 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital
- Responsible party
- Principal investigator, Sara Severin Wahlgren, Danderyd Hospital
- Investigators
- Per Y Adolphson, MD, PhD, Study director, Karolinska Institute at Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268397
- Sponsor's protocol ID
- Wilcke-02
- Acronym
- VOCAL
- Status last verified
- Apr 2018
- First submitted
- 29 Dec 2010
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sudow H, Severin S, Wilcke M, Saving J, Skoldenberg O, Navarro CM. Non-operative treatment or volar locking plate fixation for dorsally displaced distal radius fractures in patients over 70 years - a three year follow-up of a randomized controlled trial. BMC Musculoskelet Disord. 2022 May 12;23(1):447. doi: 10.1186/s12891-022-05394-7.
PubMed 35549696
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly. A Randomized Comparison Between Operative Fixation and Plaster Cast Treatment.
- ClinicalTrials.gov ID
- NCT01268397
- Acronym / sponsor ID
- VOCAL / Wilcke-02
- Conditions
- Fracture of the Distal Radius, Wrist Fracture
- Keywords
- elderly, wrist fracture, fracture of the distal radius, volar plate, plaster cast
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital
- Study start
- Dec 2009
- Primary completion
- Jan 2018 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 Dec 2010 (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 examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.
Detailed description
We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORIF | Active comparator | Procedure: open reduction and internal fixation with a volar plateOpen reduction and internal fixation with a volar plate |
| plaster treatment | Active comparator | Procedure: closed reduction and plaster treatmentClosed reduction and plaster treatment |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).
Key exclusion criteria (2 listed)
- Previous displaced fracture of the distal radius.
- Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ<5), psychiatric illness, alcohol abuse).
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 |
|---|---|---|
| open reduction and internal fixation with a volar plateAlso: plate: Königsee or Aculoc from Swemac, Swedenflexor carpi radialis approach, open reduction, fixed-angle volar plate, plaster cast 2 weeks at the surgeon's discretion | Procedure or surgery | ORIF |
| closed reduction and plaster treatmentclosed reduction, below elbow plaster cast, semicircular for 5 week | Procedure or surgery | plaster treatment |
Primary outcome
patient-perceived disability measured by the PRWE and DASH questionnaires
Time frame: one year after wrist fracture
1 secondary outcome
impairments (grip strength and range of motion compared with the uninjured wrist)
Time frame: one year after wrist fracture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Derived from this study: PubMed 35549696Sudow H, Severin S, Wilcke M, Saving J, Skoldenberg O, Navarro CM. Non-operative treatment or volar locking plate fixation for dorsally displaced distal radius fractures in patients over 70 years - a three year follow-up of a randomized controlled trial. BMC Musculoskelet Disord. 2022 May 12;23(1):447. doi: 10.1186/s12891-022-05394-7.
- Individual participant dataSharing planned: Undecided
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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.
Per Y Adolphson, MD, PhD study director
Karolinska Institute at Danderyd Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open reduction and internal fixation with a volar plate and closed reduction and plaster treatment in people with Fracture of the Distal Radius and Wrist Fracture, run by Danderyd Hospital at 1 site in Sweden.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Feb 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 Sweden. 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?
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?
patient-perceived disability measured by the PRWE and DASH questionnaires (time frame: one year after wrist fracture). 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 NCT01268397, 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 8 Feb 2019.