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

Completed

• Conditions: Monteggia's Fracture
• Interventions: Procedure: Osteosynthesis

• Registration Number: NCT05325268
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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

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 Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Study First Submitted: 2022-03-28
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Study First Posted: 2022-04-13
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Monteggia Cohort	Osteosynthesis	Including all Patients. Patients who had suffered a Monteggia fracture and were treated with osteosynthesis

Primary Outcome Measures

Name	Time	Method
Oxford Elbow Score (OES)	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
Disabilities of Arm, Shoulder and Hand Score (DASH)	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
Range of Motion (ROM)	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°.
Mayo Elbow Performance Score (MEPS)	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

Secondary Outcome Measures

Name	Time	Method
Ulnar fracture localization (Radiologically)	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 \[cm\]

Trial Locations

Locations (1)

Universitätsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany