Clinical trial NCT06011122: Analysis of Implant Placement in Patients With Distal Radius Fractures in Western Brittany (REDIRA)
Official title: Analysis of Implant Placement of Patients With Distal Radius Fractures in Western Britain,
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Distal Radius Fracture
Keywords: Distal Radius fracture
Volar plate
Plate design
Watershed line
Plate positioning
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 2723
Sex: ALL
Minimum age (years): 14
Maximum age (years): 102
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Influence of plate design on positioning
timeFrame: Retrospective study on Xray during 45 days
Secondary outcomes:
measure: Epidemiology
timeFrame: Retrospective study on Xray during 45 days
measure: Impact of fracture type on plate positioning
timeFrame: Retrospective study on Xray during 45 days
Other outcomes:
Locations:
city: Brest
country: France
facility: HIA Brest
city: Brest
country: France
facility: CHRU de brest
city: Landerneau
country: France
facility: CH de Landerneau
city: Morlaix
country: France
facility: CH des pays de Morlaix
city: Quimper
country: France
facility: CHIC de Quimper
Study officials:
affiliation: Brest UH
name: Hoel Letissier, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: