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Volar Locking Plate vs Fragment Specific Fixation in Wrist Fractures

Primary Purpose

Distal Radius Fractures

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Open reduction and fixation with TriMed fragment-specific system
Open reduction and fixation with TriMed volar locking plate
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fractures focused on measuring Fracture, Radius, Surgery, Osteosynthesis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Hand Surgery Malmö/Lund, Lund University and Skåne University Hospital, Lund, Sweden

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TriMed fragment-specific fixation

TriMed volar locking plate

Arm Description

Outcomes

Primary Outcome Measures

Grip strength
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
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)
The patients own evaluation of their arm will be measured using the QuickDASH (Quick Disabilities of the Arm Shoulder and Hand).
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
Number of reoperations
Number of participants with adverse events as a measure of safety and tolerability will be preformed
EQ-5D
The standardised EQ-5D instrument will be used as a measure of health outcome

Full Information

First Posted
March 3, 2011
Last Updated
January 23, 2014
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT01311531
Brief Title
Volar Locking Plate vs Fragment Specific Fixation in Wrist Fractures
Official Title
Treatment of Distal Radial Fractures With Volar Locking Plates Versus Fragment-specific Fixation (TriMed Classic). A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures
Keywords
Fracture, Radius, Surgery, Osteosynthesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TriMed fragment-specific fixation
Arm Type
Active Comparator
Arm Title
TriMed volar locking plate
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Open reduction and fixation with TriMed fragment-specific system
Intervention Description
Anatomical reduction, achieved by the open technique.
Intervention Type
Procedure
Intervention Name(s)
Open reduction and fixation with TriMed volar locking plate
Intervention Description
Anatomical reduction, achieved by the open technique.
Primary Outcome Measure Information:
Title
Grip strength
Description
Will be measured by a physiotherapist at 6 weeks, 3 months and 12 months. Evaluated at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Forearm rotation (pronation/supination) measured in degrees
Description
The evaluation of ange forearm rotation or range of motion preformed by a physiotherapist. It will be measured in degrees with a goniometer.
Time Frame
6 weeks, 3 months and 12 months
Title
Subjective outcome measured with QuickDASH (scale 0-100)
Description
The patients own evaluation of their arm will be measured using the QuickDASH (Quick Disabilities of the Arm Shoulder and Hand).
Time Frame
0, 6 weeks, 3 and 12 months
Title
Visual Analog Scale
Description
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
Time Frame
0, 6 weeks, 3 and 12 months
Title
Number of reoperations
Description
Number of participants with adverse events as a measure of safety and tolerability will be preformed
Time Frame
12 months
Title
EQ-5D
Description
The standardised EQ-5D instrument will be used as a measure of health outcome
Time Frame
0, 6 weeks, 3 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Tägil, MD
Organizational Affiliation
Department of Hand Surgery Malmö/Lund, Lund University and Skåne University Hospital, Lund, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hand Surgery Malmö/Lund, Lund University and Skåne University Hospital, Lund, Sweden
City
Lund
ZIP/Postal Code
221 85 Lund
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/19857180
Description
Abramo et al. 2009

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Volar Locking Plate vs Fragment Specific Fixation in Wrist Fractures

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