Monteggia Fractures: Analysis of Patient Reported Outcome Measurements in Correlation to Ulnar Fracture Localization

April 5, 2022 updated by: Technische Universität Dresden
Patients who had suffered a Monteggia fracture (lesion of the elbow) will be assessed regarding clinical and functional outcome (PROM) after treatment with osteosynthesis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A retrospective, monocentric study will be performed. Patients who underwent surgical treatment after suffering a Monteggia injury or a Monteggia like lesion between 2012 and 2018 will be included. Fractures will classified after Bado and Jupiter, according to the fracture location of the proximal ulna, as well as regarding the potential accompanying ligamentary injury.

In a follow-up examination validated patient-reported outcome measures (Disabilities of Arm, Shoulder and Hand Score [DASH], MEPS [Mayo Elbow Performance Score], Oxford Elbow Score [OES], Pain, Subjective Elbow Score) and functionality (range of motion [ROM], posterolateral instability, strength, valgus-/varus-stress) will be evaluated. In addition, treatment strategy and complications will be analysed.

Study Type

Observational

Enrollment (Actual)

35

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

  • Germany
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated at the University Hospital Dresden.

Description

Inclusion Criteria:

  • Patients with Monteggia fractures treated with osteosynthesis between 2012 and 2018
  • understanding of German language (written and oral)
  • informed consent

Exclusion Criteria:

  • Patients not meeting the above criteria

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Monteggia Cohort
Including all Patients. Patients who had suffered a Monteggia fracture and were treated with osteosynthesis
Procedure: Osteosynthesis
Treatment of fracture with open reduction and osteosynthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of Arm, Shoulder and Hand Score (DASH)
Time Frame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100
Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Oxford Elbow Score (OES)
Time Frame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Evaluation of the subjective function (patient reported outcome) using the OES-Score, 0 - 48, best: 48, worst: 0
Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Mayo Elbow Performance Score (MEPS)
Time Frame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Evaluation of the subjective function (patient reported outcome) using the MEPS-Score, 0-100, best: 100, worst: 0
Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Range of Motion (ROM)
Time Frame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Objective functional clinical result. Evaluation of Motion of the Elbow in ° measured via goniometer. Physiological: Flexion/Extension 140/0/0°.
Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ulnar fracture localization (Radiologically)
Time Frame: baseline (timepoint of injury)
Localization of ulnar fracture was measured from the proximal tip of the Olecranon to the fracture line on conventional X-ray in order to assess whether further distal fractures have a worse outcome compared to fractures with a close relation to or affecting the elbow joint [cm]
baseline (timepoint of injury)

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2018

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (ACTUAL)

April 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Monteggia PROM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No. Data may be shared upon reasonable request.

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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