Screw Lengths in Radius Volar Plates

Fracture Fixation, Internal Clinical Trial

— PESLDRF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634865
• Other study ID #: PESLDRF (29BRC18.0004)
• Status: Completed
• Start date: January 25, 2018
• Est. completion date: June 6, 2018

Study information

• Verified date: February 2018
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 6, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 85 Years

Eligibility

Inclusion Criteria:

• All CT-scans available in our database

Exclusion Criteria:

• Any pathology that could affect the radius morphology

• Refuse to participate

Related Conditions & MeSH terms

• Fracture Fixation, Internal
• Fractures, Bone
• Radius Fractures
• Radius; Fracture, Lower or Distal End
• Tendon Injuries
• Tendon Injury - Upper Limb

Locations

Country	Name	City	State
France	CHUR de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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