NCT03634865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
Last Updated

August 17, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

March 8, 2018

Last Update Submit

August 16, 2018

Conditions

Keywords

Bone trauma-fractureRadiusCT-scanInternal fixation

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age17 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All CT-scans available in our database

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUR de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2018

First Posted

August 17, 2018

Study Start

January 25, 2018

Primary Completion

June 6, 2018

Study Completion

June 6, 2018

Last Updated

August 17, 2018

Record last verified: 2018-02

Locations