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

Distal Radius Fracture Clinical Trial

— REDIRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06011122
• Other study ID #: 29BRC21.0084 - REDIRA
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: April 4, 2022

Study information

• Verified date: August 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2723
• Est. completion date: April 4, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 102 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures
• Wrist Fractures

Intervention

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

Locations

Country	Name	City	State
France	CHRU de brest	Brest
France	HIA Brest	Brest
France	CH de Landerneau	Landerneau
France	CH des pays de Morlaix	Morlaix
France	CHIC de Quimper	Quimper

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of plate design on positioning	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	Retrospective study on Xray during 45 days
Secondary	Epidemiology	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.	Retrospective study on Xray during 45 days
Secondary	Impact of fracture type on plate positioning	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	Retrospective study on Xray during 45 days

External Links

•   Brehmer JL, Husband JB. Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study
•   Corsino CB, Reeves RA, Sieg RN. Distal Radius Fractures. StatPearls, Treasure Island (FL)
•   Fractures of the distal part of the radius. The evolution of practice over time. Where's the evidence?
•   Jerrhag D, Englund M, Karlsson MK, Rosengren BE. Epidemiology and time trends of distal forearm fractures in adults - a study of 11.2 million person-years in Sweden. BMC Musculoskelet Disord
•   The Epidemiology of Upper Extremity Fractures in the United States, 2009. J Orthop Trauma 2015;29:e242-244