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

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

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.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture
• Intervention / Treatment: Procedure: Distal radius fracture ORIF with a specific volar plate

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.

• Study Type: Observational
• Enrollment (Actual): 2723

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest
  • Brest, France, 29600
    • HIA Brest
  • Landerneau, France, 29
    • CH de Landerneau
  • Morlaix, France, 29249
    • CH des Pays de Morlaix
  • Quimper, France, 29000
    • CHIC de Quimper

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We included all patients with an intra-articular or extra-articular distal radial fracture managed by Volar Locking Plate fixation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Zimmer Biomet; Patients who were operated with a Zimmer Biomet plate	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
Newclip Technics; Patients who were operated with a Newclip Technics plate	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
Stryker; Patients who were operated with a Stryker plate	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
Medartis; Patients who were operated with a Medartis plate	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
Medartis Footprint; Patients who were operated with a Medartis Footprint plate	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
Synthes; Patients who were operated with a Synthes plate	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Hoel Letissier, MD MSc, Brest UH

Publications and helpful links

Helpful Links

• 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
• 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?
• 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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 4, 2022

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Volar plate; Distal Radius fracture; Plate design; Watershed line; Plate positioning
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Fractures, Bone; Radius Fractures; Wrist Fractures
• Other Study ID Numbers: 29BRC21.0084 - REDIRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning 6 months and ending five years following the publication
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No