Volar Locking Plate vs Fragment Specific Fixation in Wrist Fractures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01311531
First received: March 3, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Distal Radius Fractures
Procedure: Open reduction and fixation with TriMed fragment-specific system
Procedure: Open reduction and fixation with TriMed volar locking plate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Distal Radial Fractures With Volar Locking Plates Versus Fragment-specific Fixation (TriMed Classic). A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Grip strength [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Will be measured by a physiotherapist at 6 weeks, 3 months and 12 months. Evaluated at 12 months.


Secondary Outcome Measures:
  • Forearm rotation (pronation/supination) measured in degrees [ Time Frame: 6 weeks, 3 months and 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The standardised EQ-5D instrument will be used as a measure of health outcome


Enrollment: 50
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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°.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01311531

Locations
Sweden
Department of Hand Surgery Malmö/Lund, Lund University and Skåne University Hospital, Lund, Sweden
Lund, Sweden, 221 85 Lund
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Magnus Tägil, MD Department of Hand Surgery Malmö/Lund, Lund University and Skåne University Hospital, Lund, Sweden
  More Information

Additional Information:
No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01311531     History of Changes
Other Study ID Numbers: ETIK 2009/318
Study First Received: March 3, 2011
Last Updated: January 23, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Fracture
Radius
Surgery
Osteosynthesis

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on April 17, 2014