Stainless steel versus titanium volar multi-axial locking plates for fixation of distal radius fractures: a randomised clinical trial

Couzens, Gregory B., Peters, Susan E., Cutbush, Kenneth, Hope, Benjamin, Taylor, Fraser, James, Christopher D., Rankin, Carly R. and Ross, Mark (2014) Stainless steel versus titanium volar multi-axial locking plates for fixation of distal radius fractures: a randomised clinical trial. BMC Musculoskeletal Disorders, 15 74: 1-7. doi:10.1186/1471-2474-15-74


Author Couzens, Gregory B.
Peters, Susan E.
Cutbush, Kenneth
Hope, Benjamin
Taylor, Fraser
James, Christopher D.
Rankin, Carly R.
Ross, Mark
Title Stainless steel versus titanium volar multi-axial locking plates for fixation of distal radius fractures: a randomised clinical trial
Journal name BMC Musculoskeletal Disorders   Check publisher's open access policy
ISSN 1471-2474
Publication date 2014-03-11
Sub-type Article (original research)
DOI 10.1186/1471-2474-15-74
Open Access Status DOI
Volume 15
Issue 74
Start page 1
End page 7
Total pages 7
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2015
Language eng
Formatted abstract
Background Distal radius fractures are among the most common fractures seen in the hospital emergency department. Of these, over 40% are considered unstable and require some form of fixation. In recent years with the advent of low profile plating, open reduction and internal fixation (ORIF) using volar plates has become the surgical treatment of choice in many hospitals. However, it is currently unknown which plating system has the lowest complication rate and/or superior clinical and radiological outcomes following surgery. Few studies have compared different types of plates, which may have various features, different plate and screw designs or may be manufactured from different materials (for example, stainless steel or titanium). This study will specifically investigate and compare the clinical and radiological outcomes and complication rates of two commonly used volar plating systems for fixation of distal radius fractures: one made from stainless steel (Trimed™ Volar Plate, Trimed™, California, USA) and the other made from titanium (Medartis® Aptus Volar Plate, Medartis®, Basel, Switzerland). The primary aim of this study is to determine if there is a difference on the Patient Reported Wrist Evaluation six months following ORIF using a volar plate for adult patients with a distal radius fracture.

Methods/Design This study will implement a randomized prospective clinical trial study design evaluating the outcomes of two different types of volar plates: one plate manufactured from stainless steel (Trimed™ Volar Plate) and one plate manufactured from titanium (Medartis® Aptus Volar Plate). The surgery will be performed at a major trauma hospital in Brisbane, Australia. Outcome measures including function, adverse events, range of movement, strength, disability, radiological findings and health-related quality of life will be collected at 6 weeks, 3, 6, 12 and 24 months following surgery. A parallel economic analysis will also be performed. This randomized clinical trial is due to deliver results in December 2016.

Discussion Results from this trial will contribute to the evidence on operative management of distal radius fractures and plate material type.

Trial registration ACTRN12612000969864
Keyword Wrist
Wrist fracture
Distal radius fracture
Surgery
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Health and Rehabilitation Sciences Publications
 
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Created: Fri, 21 Mar 2014, 08:35:06 EST by Susan Peters on behalf of School of Health & Rehabilitation Sciences