Skip to main content
OpenTrials
Completed

NCT Number: NCT05325268

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

Patients who had suffered a Monteggia fracture (lesion of the elbow) will be assessed regarding clinical and functional outcome (PROM) after treatment with osteosynthesis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Monteggia's Fracture Arm Injuries Elbow Injuries Fracture Dislocation Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Ulna Fractures Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteosynthesis

Procedure

Treatment of fracture with open reduction and osteosynthesis

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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°.

Secondary outcomes

  1. 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]

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2022
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.