Volar Locking Plate vs Fragment Specific Fixation in Wrist Fractures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01311531|
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : January 24, 2014
|Condition or disease||Intervention/treatment||Phase|
|Distal Radius Fractures||Procedure: Open reduction and fixation with TriMed fragment-specific system Procedure: Open reduction and fixation with TriMed volar locking plate||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Distal Radial Fractures With Volar Locking Plates Versus Fragment-specific Fixation (TriMed Classic). A Randomized Trial|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
|Active Comparator: TriMed fragment-specific fixation||
Procedure: Open reduction and fixation with TriMed fragment-specific system
Anatomical reduction, achieved by the open technique.
|Active Comparator: TriMed volar locking plate||
Procedure: Open reduction and fixation with TriMed volar locking plate
Anatomical reduction, achieved by the open technique.
- Grip strength [ Time Frame: 12 months ]Will be measured by a physiotherapist at 6 weeks, 3 months and 12 months. Evaluated at 12 months.
- Forearm rotation (pronation/supination) measured in degrees [ Time Frame: 6 weeks, 3 months and 12 months ]The evaluation of ange forearm rotation or range of motion preformed by a physiotherapist. It will be measured in degrees with a goniometer.
- Subjective outcome measured with QuickDASH (scale 0-100) [ Time Frame: 0, 6 weeks, 3 and 12 months ]The patients own evaluation of their arm will be measured using the QuickDASH (Quick Disabilities of the Arm Shoulder and Hand).
- Visual Analog Scale [ Time Frame: 0, 6 weeks, 3 and 12 months ]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
- Number of reoperations [ Time Frame: 12 months ]Number of participants with adverse events as a measure of safety and tolerability will be preformed
- EQ-5D [ Time Frame: 0, 6 weeks, 3 and 12 months ]The standardised EQ-5D instrument will be used as a measure of health outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311531
|Department of Hand Surgery Malmö/Lund, Lund University and Skåne University Hospital, Lund, Sweden|
|Lund, Sweden, 221 85 Lund|
|Principal Investigator:||Magnus Tägil, MD||Department of Hand Surgery Malmö/Lund, Lund University and Skåne University Hospital, Lund, Sweden|