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

NCT05325268 | Completed DMC

• 1 other identifier: Monteggia PROM
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Monteggia's Fracture

Keywords

elbow; fracture; patient reported outcome

Outcome Measures

Primary Outcomes (4)

• Disabilities of Arm, Shoulder and Hand Score (DASH)

  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)

  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)

  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)

  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 Outcomes (1)

• Ulnar fracture localization (Radiologically)

  baseline (timepoint of injury)

Study Arms (1)

Monteggia Cohort

Including all Patients. Patients who had suffered a Monteggia fracture and were treated with osteosynthesis

Procedure: Osteosynthesis

Interventions

Osteosynthesis PROCEDURE

Treatment of fracture with open reduction and osteosynthesis

Monteggia Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated at the University Hospital Dresden.

You may qualify if:

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

You may not qualify if:

• Patients not meeting the above criteria

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Universitätsklinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Related Publications (1)

• Tille E, Seidel L, Schlussler A, Beyer F, Kasten P, Bota O, Biewener A, Nowotny J. Monteggia fractures: analysis of patient-reported outcome measurements in correlation with ulnar fracture localization. J Orthop Surg Res. 2022 Jun 7;17(1):303. doi: 10.1186/s13018-022-03195-1.

  PMID: 35672754 DERIVED

MeSH Terms

Conditions

Monteggia's Fracture; Fractures, Bone

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Ulna Fractures

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

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

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 13, 2022
• Study Start: June 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)