Distal Radius FracturesNCT01311531
Volar Locking Plate vs Fragment Specific Fixation in Wrist Fractures
A study testing Open reduction and fixation with TriMed fragment-specific system and Open reduction and fixation with TriMed volar locking plate in people with Distal Radius Fractures, run by Region Skane at 1 site in Sweden.
Trial summary
The treatment of unstable, non-reducible distal radial fractures is still controversial. The aim of the present study is to compare the subjective, clinical and radiographic outcome of the TriMed fragment-specific system with a volar locking plate in patients with unstable, non-reducible and also redislocated distal… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Open reduction and fixation with TriMed fragment-specific system and Open reduction and fixation with TriMed volar locking plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2010to Dec 2013
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AO type A or C fracture, unstable and non-reducible at day of trauma.
- AO type A or C fracture, redislocated at the 14 day clinical and radiological control.
- Incongruent RC-joint or DRU-joint and/or axial compression > 2 mm and/or dorsal compression 20°.
Who cannot join
- Previous fracture of the same wrist
- Volar Barton fractures (AO Type B)
- Fracture on the other side or other concomitant fracture that also needs treatment.
- Open fracture
- Fracture expansion to the diaphysis
- Ongoing chemo- or radiotherapy
- Metabolic diseases that affect the bone
- Dementia, mental illness, alcohol abuse or difficulty understanding the language
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Hand Surgery Malmö/Lund, Lund University and Skåne University Hospital, Lund, Sweden
Lund, 221 85 Lund
About this study
Official title: Treatment of Distal Radial Fractures With Volar Locking Plates Versus Fragment-specific Fixation (TriMed Classic). A Randomized Trial
The treatment of unstable, non-reducible distal radial fractures is still controversial. The aim of the present study is to compare the subjective, clinical and radiographic outcome of the TriMed fragment-specific system with a volar locking plate in patients with unstable, non-reducible and also redislocated distal radial fractures.
Read the detailed description
The distal radial fracture is one of the most common fractures, with an annual incidence in southern Sweden of 26 per 10,000 inhabitants (Brogren et al. 2007). Non-surgical treatment, predominantly plaster cast or simple splints, comprises the basic treatment in non-displaced fractures, as well as in displaced, but reducible fractures (Handoll and Madhok 2003). In the unstable, non-reducible distal radial fractures, surgical treatment is necessary but can be complex. The choice of method is still controversial (Chen and Jupiter 2007), especially regarding the result over time (Downing and Karantana 2008). External fixation has been the preferred method of operation for decades, but with the introduction of the volar locking plate technique, internal fixation has rapidly become more and more popular, without any solid foundation in the evidence-based medicine (Margaliot et al. 2005).
We have shown in a randomized study that open reduction and internal fixation of distal radial fractures using the TriMed fragment-specific system resulted in better grip strength and forearm rotation at 1-year follow up than closed reduction and bridging external fixation (Abramo et al. 2009). Later we followed up the same cohort at a mean of 5-years, with the primary aim of determining whether the superior results of internal fixation in unstable distal radial fractures persist over time. The conclusion of this study was that, internal fixation is better than external fixation regarding grip strength and forearm rotation at 1-year but the difference disappears at the 5-year follow-up as both groups approach normal values (Landgren et al. submitted in 2010).
The aim of the present study is to compare the subjective, clinical and radiographic outcome of the TriMed fragment-specific system with a volar locking plate in patients with unstable, non-reducible and also redislocated distal radial fractures. The patients who meet all eligibility criteria and provide consent to participate will be randomly assigned to reduction and fixation with either volar locking plate or Trimed fragment-specific system. Patients will undergo physiotherapy, clinical evaluation, radiographic evaluation at fixed intervals and will also include QuickDASH, VAS, SF-12 and EQ5D. There will be 25 patients in each arm and the patients will be followed for 12 months.
- Conditions
- Distal Radius Fractures
- Being tested
- Open reduction and fixation with TriMed fragment-specific system, Open reduction and fixation with TriMed volar locking plate
- Keywords
- Fracture, Radius, Surgery, Osteosynthesis
- Medical subject headings
- Wrist Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and fixation with TriMed fragment-specific systemProcedure or surgery
Anatomical reduction, achieved by the open technique.
Open reduction and fixation with TriMed volar locking plateProcedure or surgery
Anatomical reduction, achieved by the open technique.
| Study group | Role | What they receive |
|---|---|---|
| TriMed fragment-specific fixation | Active comparator | Not described Receives: Procedure: Open reduction and fixation with TriMed fragment-specific system |
| TriMed volar locking plate | Active comparator | Not described Receives: Procedure: Open reduction and fixation with TriMed volar locking plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
Will be measured by a physiotherapist at 6 weeks, 3 months and 12 months. Evaluated at 12 months.
Measured: 12 months
Secondary outcomes (5)
Forearm rotation (pronation/supination) measured in degrees
The evaluation of ange forearm rotation or range of motion preformed by a physiotherapist. It will be measured in degrees with a goniometer.
Measured: 6 weeks, 3 months and 12 months
Subjective outcome measured with QuickDASH (scale 0-100)
The patients own evaluation of their arm will be measured using the QuickDASH (Quick Disabilities of the Arm Shoulder and Hand).
Measured: 0, 6 weeks, 3 and 12 months
Visual Analog Scale
The Visual Analog Scale (VAS) will be used to evaluated different parameters: pain in rest, pain in work, function and cosmetic appearance of the hand
Measured: 0, 6 weeks, 3 and 12 months
Number of reoperations
Number of participants with adverse events as a measure of safety and tolerability will be preformed
Measured: 12 months
EQ-5D
The standardised EQ-5D instrument will be used as a measure of health outcome
Measured: 0, 6 weeks, 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magnus Tägil, MD, Principal investigator, Department of Hand Surgery Malmö/Lund, Lund University and Skåne University Hospital, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311531
- Sponsor's protocol ID
- ETIK 2009/318
- Status last verified
- Jan 2014
- First submitted
- 3 Mar 2011
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Distal Radial Fractures With Volar Locking Plates Versus Fragment-specific Fixation (TriMed Classic). A Randomized Trial
- ClinicalTrials.gov ID
- NCT01311531
- Acronym / sponsor ID
- ETIK 2009/318
- Conditions
- Distal Radius Fractures
- Keywords
- Fracture, Radius, Surgery, Osteosynthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Mar 2011 (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 treatment of unstable, non-reducible distal radial fractures is still controversial. The aim of the present study is to compare the subjective, clinical and radiographic outcome of the TriMed fragment-specific system with a volar locking plate in patients with unstable, non-reducible and also redislocated distal radial fractures.
Detailed description
The distal radial fracture is one of the most common fractures, with an annual incidence in southern Sweden of 26 per 10,000 inhabitants (Brogren et al. 2007). Non-surgical treatment, predominantly plaster cast or simple splints, comprises the basic treatment in non-displaced fractures, as well as in displaced, but reducible fractures (Handoll and Madhok 2003). In the unstable, non-reducible distal radial fractures, surgical treatment is necessary but can be complex. The choice of method is still controversial (Chen and Jupiter 2007), especially regarding the result over time (Downing and Karantana 2008). External fixation has been the preferred method of operation for decades, but with the introduction of the volar locking plate technique, internal fixation has rapidly become more and more popular, without any solid foundation in the evidence-based medicine (Margaliot et al. 2005).
We have shown in a randomized study that open reduction and internal fixation of distal radial fractures using the TriMed fragment-specific system resulted in better grip strength and forearm rotation at 1-year follow up than closed reduction and bridging external fixation (Abramo et al. 2009). Later we followed up the same cohort at a mean of 5-years, with the primary aim of determining whether the superior results of internal fixation in unstable distal radial fractures persist over time. The conclusion of this study was that, internal fixation is better than external fixation regarding grip strength and forearm rotation at 1-year but the difference disappears at the 5-year follow-up as both groups approach normal values (Landgren et al. submitted in 2010).
The aim of the present study is to compare the subjective, clinical and radiographic outcome of the TriMed fragment-specific system with a volar locking plate in patients with unstable, non-reducible and also redislocated distal radial fractures. The patients who meet all eligibility criteria and provide consent to participate will be randomly assigned to reduction and fixation with either volar locking plate or Trimed fragment-specific system. Patients will undergo physiotherapy, clinical evaluation, radiographic evaluation at fixed intervals and will also include QuickDASH, VAS, SF-12 and EQ5D. There will be 25 patients in each arm and the patients will be followed for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TriMed fragment-specific fixation | Active comparator | Procedure: Open reduction and fixation with TriMed fragment-specific system |
| TriMed volar locking plate | Active comparator | Procedure: Open reduction and fixation with TriMed volar locking plate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AO type A or C fracture, unstable and non-reducible at day of trauma.
- AO type A or C fracture, redislocated at the 14 day clinical and radiological control.
- Incongruent RC-joint or DRU-joint and/or axial compression > 2 mm and/or dorsal compression 20°.
Key exclusion criteria (8 listed)
- Previous fracture of the same wrist
- Volar Barton fractures (AO Type B)
- Fracture on the other side or other concomitant fracture that also needs treatment.
- Open fracture
- Fracture expansion to the diaphysis
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 fixation with TriMed fragment-specific systemAnatomical reduction, achieved by the open technique. | Procedure or surgery | TriMed fragment-specific fixation |
| Open reduction and fixation with TriMed volar locking plateAnatomical reduction, achieved by the open technique. | Procedure or surgery | TriMed volar locking plate |
Primary outcome
Grip strength
Time frame: 12 months
Will be measured by a physiotherapist at 6 weeks, 3 months and 12 months. Evaluated at 12 months.
5 secondary outcomes
Forearm rotation (pronation/supination) measured in degrees
Time frame: 6 weeks, 3 months and 12 months
Subjective outcome measured with QuickDASH (scale 0-100)
Time frame: 0, 6 weeks, 3 and 12 months
Visual Analog Scale
Time frame: 0, 6 weeks, 3 and 12 months
Number of reoperations
Time frame: 12 months
EQ-5D
Time frame: 0, 6 weeks, 3 and 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 24 Jan 2014.
- Abramo et al. 2009Link provided by the sponsor.
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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.
Magnus Tägil, MD principal investigator
Department of Hand Surgery Malmö/Lund, Lund University and Skåne University Hospital, Lund, Sweden
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 fixation with TriMed fragment-specific system and Open reduction and fixation with TriMed volar locking plate in people with Distal Radius Fractures, run by Region Skane 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 3 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: finished, as of the sponsor's last update on 24 Jan 2014. 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?
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?
Grip strength (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 24 Jan 2014.