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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Distal Radius Fracture

Treatments: Procedure: Distal radius fracture ORIF with a specific volar plate

Study type: Observational

Funder types: Other

Identifiers

NCT06011122

29BRC21.0084 - REDIRA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,723 patients

Sex: All

Ages: 14 to 102 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

2,723 participants in 6 patient groups

Zimmer Biomet

Description:

Patients who were operated with a Zimmer Biomet plate

Treatment:

Procedure: Distal radius fracture ORIF with a specific volar plate

Newclip Technics

Description:

Patients who were operated with a Newclip Technics plate

Treatment:

Procedure: Distal radius fracture ORIF with a specific volar plate

Stryker

Description:

Patients who were operated with a Stryker plate

Treatment:

Procedure: Distal radius fracture ORIF with a specific volar plate

Medartis

Description:

Patients who were operated with a Medartis plate

Treatment:

Procedure: Distal radius fracture ORIF with a specific volar plate

Medartis Footprint

Description:

Patients who were operated with a Medartis Footprint plate

Treatment:

Procedure: Distal radius fracture ORIF with a specific volar plate

Synthes

Description:

Patients who were operated with a Synthes plate

Treatment:

Procedure: Distal radius fracture ORIF with a specific volar plate