Minimally invasive plating of fractures of the upper aspect of the upper arm and its implication to muscle insertions and shoulder functio

Not Applicable

Completed

• Conditions: Potential damage to the deltoid muscle insertion caused by blunt advancement of a minimally invasive plate along the lateral aspect of the humerus to bridge a fracture; Surgery

• Registration Number: ISRCTN51786146
• Lead Sponsor: Kantonsspital Winterthur

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37936156/ (added 08/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-10
• Study Start: 2023-05-26
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Patients with MILPOH for diaphyseal fractures of the humerus with extension into the proximal metaphysis, operated on at Cantonal Hospital Winterthur between 03/2017 and 08/2020
2. Patients with normal function of the affected extremity and the contralateral side before trauma
3. >18 years of age

Exclusion Criteria

1. Previous humerus fracture to either side
2. Impaired shoulder function prior to trauma
3. Claustrophobia (not suitable for MRI)
4. Previous shoulder or upper arm surgery on either side

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> All measured at least 1 year postoperatively, time range 12-48 months:<br> 1. Abduction and flexion strength of the deltoid muscle at 30°, 60°, 90° of the affected and uninjured side, measured using an electronic isometric strength dynamometer (IsoForceControl EVO2; Medical Device Solutions AG, Oberburg, Switzerland).<br> 2. Imaging of the deltoid muscle and its distal insertion performed by MR imaging (1.5T MRI scanner [Ingenia, Philips Healthcare, Best, the Netherlands])<br>

Secondary Outcome Measures

Name	Time	Method
<br> All measured at least 1 year postoperatively, time range 12-48 months:<br> 1. Overall shoulder function measured using the Constant-Murley Score (CMS) and gender- and age-adapted CMS<br> 2. Shoulder pain and function measured using the Oxford Shoulder Score (OSS)<br> 3. Upper-extremity disability and symptoms measured using the Disabilities for the Arm, Shoulder, and Hand (DASH) outcome measure<br> 4. Patient's self-rated health measured using EQ-5D-5L visual analogue score (VAS)<br> 5. Mobility, self-care, usual activities, pain and anxiety/depression measured using EQ-5D-5L<br>