NCT06011122

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,723 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 14 Years – 102 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Distal Radius Fracture

Interventions

Type	Name	Description
PROCEDURE	Distal radius fracture ORIF with a specific volar plate	Patients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-04-01
• Completion: 2022-04-04
• First posted: 2023-08-25
• Last updated: 2023-08-25

Locations

5 sites across 1 country: France