Skip to main content
OpenTrials
Completed

NCT Number: NCT06011122

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

14 year–102 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de brest, Brest, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Distal radius fracture ORIF with a specific volar plate

Procedure

Patients who had a distal radius fracture were treated surgically : an ORIF was realised with a volar plate

Primary outcomes

  1. 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

  1. Epidemiology

    Time frame: 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.

  2. Impact of fracture type on plate positioning

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: REDIRA

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 25, 2023
Registry last updated
Aug 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.