Screw Lengths in Radius Volar Plates (PESLDRF)

Volar Plates for Distal Radius : Can Epiphyseal Screw Length be Predicted

Background Fractures of the distal radius are among the most common. Major complications, including irritation and rupture of the extensor tendons, may occur if epiphyseal screws of inappropriate length are used.

Questions/Purposes The main objective of the present study was to determine whether the optimal epiphyseal screw length can be determined by reference to the diaphyseal screw length.

Methods Forty CT scans were semi-automatically segmented. A 3D model of the volar plate was affixed to each distal radius with simulation. The maximum lengths of the diaphyseal screws, as well as the four distal epiphyseal screws, were measured. Linear regression analysis was performed.

Study Overview

• Status: Completed
• Conditions: Fracture Fixation, Internal; Radius; Fracture, Lower or Distal End; Tendon Injury - Upper Limb

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHUR de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that underwent for a CT-Scan of the distal radius from October 2016 to February 2018

Description

Inclusion Criteria:

• All CT-scans available in our database

Exclusion Criteria:

• Any pathology that could affect the radius morphology
• Refuse to participate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main objective	The main objective of this study was twofold: 1) to assess the anatomical correlation between diaphysis thickness in the diaphyseal screw region of volar plates and epiphyseal thickness in lateral plane with linear regression analysis for each epiphyseal screw length with regard to the diaphysis screw length, and 2) to evaluate whether the optimal epiphyseal screw lengths can be predicted by reference to the diaphyseal screw length when diaphyseal screws are first positioned. From the CT-scans, Reconstructions in 3D of the radius were realized. Those reconstructions were used in a computer-simulation study. A Volar plate was affixed to the radius using a specific software. Maximum length for each screw located either in epiphysis or diaphysis was measured in mm. This length corresponded with the distance between the entry point of the screw and the opposite point belonging to the wrist along the line perpendicular to the plate.	The measures were performed after the CT-Scans were realized. The CT-Scans were performed from October 2016 to February 2018. The measures on the CT-Scans were realized in june 2018

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2018
• Primary Completion (Actual): June 6, 2018
• Study Completion (Actual): June 6, 2018

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Internal fixation; CT-scan; Radius; Bone trauma-fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures; Tendon Injuries
• Other Study ID Numbers: PESLDRF (29BRC18.0004)

Drug and device information, study documents

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