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

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT06011122

Collaborator

(none)

2,723

Enrollment

Locations

1.1

Actual Duration (Months)

544.6

Patients Per Site

487.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fracture	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 Design

Study Type:

Observational

Actual Enrollment :

2723 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Actual Primary Completion Date :

Apr 1, 2022

Actual Study Completion Date :

Apr 4, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Influence of plate design on positioning [Retrospective study on Xray during 45 days]
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

Secondary Outcome Measures

Epidemiology [Retrospective study on Xray during 45 days]
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.
Impact of fracture type on plate positioning [Retrospective study on Xray during 45 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 102 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	HIA Brest	Brest	France	29600
2	CHRU de brest	Brest	France	29609
3	CH de Landerneau	Landerneau	France	29
4	CH des pays de Morlaix	Morlaix	France	29249
5	CHIC de Quimper	Quimper	France	29000