Anterior Plate Osteosynthesis of Fractures of the Lower Extremity of the Radius: Does the Systematic Use of Short Epiphysic Screws Limit the Posterior Protrusion of the Screws Without Compromising Stability (SHORT)

November 15, 2019 updated by: Assistance Publique - Hôpitaux de Paris

Anterior plate osteosynthesis of fractures of the lower extremity of the radius may be accompanied by tendinous complications : tenosynovitis of extensors or even tendon ruptures caused by the end of the epiphyseai screws.

The intraoperative measurements as well as the realization of the scopic pictures make it possible to estimate the length of the screws but the tendinous lesions remain frequent (5 to 15% according to the various series)

Study Overview

Status

Unknown

Conditions

Detailed Description

  • Preoperative consultation

    • Oral information of the patient of the protocol and delivery of the written information note
    • Seeking patient's non-opposition to participating in the study
    • Inclusion of the patient

  • Surgical procedure for distal radius fracture + immediate post-operative radiography

    • Intervention performed according to the usual practices of the service by the surgeon of the day without randomization
    • Radiography: 2 shots: face and wrist profile

  • Control X-ray + consultation

    • Achieved at 3 weeks, 6 weeks and 3 months after the intervention
    • X-rays: 2 shots: face and wrist profile
  • Control ultrasound o Realized at 3 months after the intervention

End of participation in the study after consultation of 3 months.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients operated on for a fractured distal radius with an anterior locked plate in orthopaedic and trauma surgery in Saint Antoine Hospital, Paris

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Fracture (s) of extra joint distal radius with or without joint refend in the sagitta plane
  • Osteosynthesis by anterior locked plate
  • Patient who did not oppose his participation in this research

Exclusion Criteria:

  • Distal radius fractures with joint refend frontal (posterior marginal)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Screws exceeding the posterior cortical
Time Frame: 3 months
Proportion of tendon complications induced by conflict between the distal end of the epiphysal screws and extender tendons: rupture, tenosynovitis.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tendon complications
Time Frame: 3 months
Proportion of tendon complications induced by conflict between the distal end of the epiphysal screws and extender tendons: rupture, tenosynovitis.
3 months
Secondary displacement or dismantling
Time Frame: 3 months
Proportion of secondary displacement or dismantling 3-month control radio equipment (change of the radial slope on the face and radial glene's anversion on the profile between X-rays at J0 and control x-rays)
3 months
Ablation of material or resumption early surgery
Time Frame: 3 months
Proportion of ablation of material or resumption early surgery on secondary displacement rated at 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Olivier HERISSON, Dr, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2019

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 15, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP 190158
  • 2019-A00429-48 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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