Analysis of Implant Placement in Patients With Distal Radius Fractures in Western Brittany (REDIRA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Analysis of Implant Placement of Patients With Distal Radius Fractures in Western Britain,

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Procedure: Distal radius fracture ORIF with a specific volar plate


Participation Criteria
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Eligibility Criteria
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To be included, patients had to have a digital radiographic file that could be used for the Soong classification. Among the volar plate fixation cases retrieved from the databases, we excluded patients that were not treated with a locking plate and those with a lateral x-ray that could not be interpreted. The inclusion criteria for lateral radiographs were alignment of the radius, lunate, capitate and third metacarpal bones, combined with radial-ulnar overlap (the ulnar styloid process projecting into the middle of the ulnar head). Exclusion criteria: Patient refusal No postoperative radiograph N=40 Poor quality radiograph N=214

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 102 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Zimmer Biomet<br>Patients who were operated with a Zimmer Biomet plate | Procedure: Distal radius fracture ORIF with a specific volar plate<br>* Patients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate<br>|
| Newclip Technics<br>Patients who were operated with a Newclip Technics plate | Procedure: Distal radius fracture ORIF with a specific volar plate<br>* Patients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate<br>|
| Stryker<br>Patients who were operated with a Stryker plate | Procedure: Distal radius fracture ORIF with a specific volar plate<br>* Patients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate<br>|
| Medartis<br>Patients who were operated with a Medartis plate | Procedure: Distal radius fracture ORIF with a specific volar plate<br>* Patients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate<br>|
| Medartis Footprint<br>Patients who were operated with a Medartis Footprint plate | Procedure: Distal radius fracture ORIF with a specific volar plate<br>* Patients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate<br>|
| Synthes<br>Patients who were operated with a Synthes plate | Procedure: Distal radius fracture ORIF with a specific volar plate<br>* Patients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of plate design on positioning | 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 | Retrospective study on Xray during 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiology | 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. | Retrospective study on Xray during 45 days | 
| Impact of fracture type on plate positioning | 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 | Retrospective study on Xray during 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal Radius fracture, Volar plate, Plate design, Watershed line, Plate positioning