PESLDRF: Screw Lengths in Radius Volar Plates

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT03634865

Collaborator

(none)

Enrollment

Location

4.3

Actual Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Radius; Fracture, Lower or Distal End Tendon Injury - Upper Limb Fracture Fixation, Internal

Study Design

Study Type:

Observational

Actual Enrollment :

41 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 25, 2018

Actual Primary Completion Date :

Jun 6, 2018

Actual Study Completion Date :

Jun 6, 2018

Outcome Measures

Primary Outcome Measures

Main objective [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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All CT-scans available in our database

Exclusion Criteria:

Any pathology that could affect the radius morphology
Refuse to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHUR de Brest	Brest		France	29609

Sponsors and Collaborators

University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT03634865

Other Study ID Numbers:

PESLDRF (29BRC18.0004)

First Posted:

Aug 17, 2018

Last Update Posted:

Aug 17, 2018

Last Verified:

Feb 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Brest

Additional relevant MeSH terms:

Fractures, Bone

Tendon Injuries

Radius Fractures

Study Results

No Results Posted as of Aug 17, 2018