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

NCT ID: NCT06011122

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2723 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-04-04

Brief Summary

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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

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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.

Conditions

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Distal Radius Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Zimmer Biomet

Patients who were operated with a Zimmer Biomet plate

Distal radius fracture ORIF with a specific volar plate

Intervention Type PROCEDURE

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

Distal radius fracture ORIF with a specific volar plate

Intervention Type PROCEDURE

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

Distal radius fracture ORIF with a specific volar plate

Intervention Type PROCEDURE

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

Distal radius fracture ORIF with a specific volar plate

Intervention Type PROCEDURE

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

Distal radius fracture ORIF with a specific volar plate

Intervention Type PROCEDURE

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

Distal radius fracture ORIF with a specific volar plate

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

Patient refusal No postoperative radiograph N=40 Poor quality radiograph N=214
Minimum Eligible Age

14 Years

Maximum Eligible Age

102 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hoel Letissier, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Brest UH

Locations

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HIA Brest

Brest, , France

Site Status

CHRU de brest

Brest, , France

Site Status

CH de Landerneau

Landerneau, , France

Site Status

CH des pays de Morlaix

Morlaix, , France

Site Status

CHIC de Quimper

Quimper, , France

Site Status

Countries

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France

Related Links

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https://doi.org/10.1186/s12891-017-1596-z

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

https://doi.org/10.1097/BOT.0000000000000312

The Epidemiology of Upper Extremity Fractures in the United States, 2009. J Orthop Trauma 2015;29:e242-244

https://doi.org/10.2106/JBJS.G.01569

Corsino CB, Reeves RA, Sieg RN. Distal Radius Fractures. StatPearls, Treasure Island (FL)

https://doi.org/10.2106/JBJS.M.00860

Fractures of the distal part of the radius. The evolution of practice over time. Where's the evidence?

https://doi.org/10.1016/j.injury.2017.10.010

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

Other Identifiers

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29BRC21.0084 - REDIRA

Identifier Type: -

Identifier Source: org_study_id

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