Analysis of Implant Placement in Patients With Distal Radius Fractures in Western Brittany (REDIRA)
- Conditions
- Distal Radius Fracture
- Interventions
- Procedure: Distal radius fracture ORIF with a specific volar plate
- Registration Number
- NCT06011122
- Lead Sponsor
- University Hospital, Brest
- Brief Summary
The purpose of this study was to determine the impact of design on plate position at the level of the distal radius. Six anterior wrist plates design were analyzed relative to the watershed line using the Soong classification. A total of 2723 anterior locking plate fixation cases were analyzed and divided into six groups: Zimmer Biomet, Newclip Technics, Stryker, Synthes, Medartis and Medartis Footprint. The number of plates recorded as Soong grade 0+1 was determined for each design, then compared using the Marascuilo procedure. The Zimmer Biomet and Newclip plates were proximal to the Watershed line significantly more often than those by Synthes and Medartis Footprint. Plate position with the Medartis design was significantly more proximal to the Watershed line compared to its companion design, the Medartis Footprint plate. Plate design is a deciding factor when treating distal radial fractures, to avoid impingement when implant removal is not routinely planned.
- Detailed Description
This is a retrospective multicenter study involving several orthopedic surgeons with a trauma surgery practice within the public hospital centers of the department of Finistère. These include the CHU de Brest - Brest University Hospital Center (La Cavale Blanche), the HIA Clermont-Tonnerre military hospital (Hôpital d'Instruction des Armées - Armed Forces Teaching Hospital), the CH des Pays de Morlaix, the CH de Landerneau Ferdinand Grall, the CH de Carhaix and the CH de Cornouaille Quimper Concarneau. This study was approved by the local ethics committee. Among the cited hospital centers, the CHU de Brest is a level 1 trauma center, the CH des pays de Morlaix, the HIA military hospital and the CH de Cornouaille are level 2 trauma centers and the CH de Landerneau and Carhaix are level 3 trauma centers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2723
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Newclip Technics Distal radius fracture ORIF with a specific volar plate Patients who were operated with a Newclip Technics plate Stryker Distal radius fracture ORIF with a specific volar plate Patients who were operated with a Stryker plate Medartis Footprint Distal radius fracture ORIF with a specific volar plate Patients who were operated with a Medartis Footprint plate Zimmer Biomet Distal radius fracture ORIF with a specific volar plate Patients who were operated with a Zimmer Biomet plate Medartis Distal radius fracture ORIF with a specific volar plate Patients who were operated with a Medartis plate Synthes Distal radius fracture ORIF with a specific volar plate Patients who were operated with a Synthes plate
- Primary Outcome Measures
Name Time Method Influence of plate design on positioning Retrospective study on Xray during 45 days The primary aim of this study was to compare six different VLPs meant to be positioned proximal to the watershed line, using the Soong classification.
We will assess the rate of plates positioned "Soong 0+1" for each plate design
- Secondary Outcome Measures
Name Time Method Epidemiology Retrospective study on Xray during 45 days to study the epidemiology of VLP fixation, per year, as recorded by the department of Finistère (northwestern France).
We will assess for every year between 2009 and 2020 the prevalence of distal fracture treated by the use of a volar plate.Impact of fracture type on plate positioning Retrospective study on Xray during 45 days determine whether the type of fracture has an impact on plate position as defined by the Soong classification. We will assess the rates of different types of fractures according to AO classification and the rate of plates "Soong 0+1" for each fracture type
Trial Locations
- Locations (5)
HIA Brest
🇫🇷Brest, France
CHRU de brest
🇫🇷Brest, France
CH de Landerneau
🇫🇷Landerneau, France
CH des pays de Morlaix
🇫🇷Morlaix, France
CHIC de Quimper
🇫🇷Quimper, France