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Clinical Trials/NCT06011122
NCT06011122
Completed
N/A

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

University Hospital, Brest5 sites in 1 country2,723 target enrollmentMarch 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Distal Radius Fracture
Sponsor
University Hospital, Brest
Enrollment
2723
Locations
5
Primary Endpoint
Influence of plate design on positioning
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
April 4, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Influence of plate design on positioning

Time Frame: 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 Outcomes

  • Epidemiology(Retrospective study on Xray during 45 days)
  • Impact of fracture type on plate positioning(Retrospective study on Xray during 45 days)

Study Sites (5)

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