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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06011122
Acronym
REDIRA
Enrollment
2723
Registered
2023-08-25
Start date
2022-03-01
Completion date
2022-04-04
Last updated
2023-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture

Keywords

Distal Radius fracture, Volar plate, Plate design, Watershed line, Plate positioning

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.

Interventions

PROCEDUREDistal 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

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 102 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Influence of plate design on positioningRetrospective study on Xray during 45 daysThe 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

MeasureTime frameDescription
EpidemiologyRetrospective study on Xray during 45 daysto 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 positioningRetrospective study on Xray during 45 daysdetermine 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026