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

ISRCTN	ISRCTN51786146
DOI	https://doi.org/10.1186/ISRCTN51786146
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	BASEC Nr.: 2021-00811
Sponsor	Kantonsspital Winterthur
Funder	Cantonal Hospital Winterthur

Submission date: 25/05/2023
Registration date: 26/05/2023
Last edited: 08/11/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
A bridging plate can be surgically introduced to stabilise a humerus (upper arm bone) fracture. However, the deltoid muscle insertion may be penetrated when the plate is advanced downward to the bone to its final position. The aim of this study is to investigate whether this manoeuvre causes functional deficits and alterations of the deltoid muscle itself.

Who can participate?
Patients aged over 18 years undergoing surgery for a humerus fracture at Cantonal Hospital Winterthur

What does the study involve?
Participants undergo further tests at least 1 year after surgery, including functional testing (muscle strength) and MRI scans of both the affected and uninjured shoulder and upper arm. Patient-related outcome measurements are also obtained.

What are the possible benefits and risks of participating?
The study does not alter the outcome of the participants as it does not influence their treatment in any way. Besides the usual risks of MRI scans, no risks are involved.

Where is the study run from?
Cantonal Hospital Winterthur (Switzerland)

When is the study starting and how long is it expected to run for?
February 2021 to December 2021

Who is funding the study?
Cantonal Hospital Winterthur (Switzerland)

Who is the main contact?
Prof. Dr med. Christoph Meier, christoph.meier@ksw.ch

Contact information

Prof Christoph Meier
Public

Cantona Hospital Winterthur
Brauerstrasse 15
Winterthur
8401
Switzerland

ORCID ID	0000-0001-6944-9648
Phone	+41 (0)522662411
Email	christoph.meier@ksw.ch

Prof Christoph Meier
Scientific

Cantona Hospital Winterthur
Brauerstrasse 15
Winterthur
8401
Switzerland

Phone	+41 (0)522662411
Email	christoph.meier@ksw.ch

Prof Christoph Meier
Principal investigator

Cantona Hospital Winterthur
Brauerstrasse 15
Winterthur
8401
Switzerland

Phone	+41 (0)5222662411
Email	christoph.meier@ksw.ch

Study information

Primary study design	Observational
Study design	Observational case series
Secondary study design	Case series
Study type	Participant information sheet
Scientific title	Minimally invasive lateral plating for diaphyseal fractures with extension into the proximal humerus and its implications for the deltoid muscle and its distal insertion: functional analysis and MR imaging
Study objectives	In minimally invasive lateral plate osteosynthesis of the humerus (MILPOH) the plate is introduced through a deltoid split proximally and advanced through the central portion of the deltoid insertion and between bone and brachial muscle to the distal aspect of the humerus. The fracture is then indirectly reduced and bridged by the plate. It was the aim of this study to evaluate the implications of this maneuver on the integrity of the deltoid insertion and muscle function.
Ethics approval(s)	Approved 01/11/2022, Kantonale Ethikkommission Kanton Zürich (Stampfenbachstrasse, 121 Postfach, 8090 Zurich, Switzerland; +41 (0)43 259 79 70; admin.kek@kek.zh.ch), ref: 2021-00811
Health condition(s) or problem(s) studied	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
Intervention	The charts of all patients with MILPOH for diaphyseal fractures of the humerus with extension into the proximal metaphysis, operated at our institution between 03/2017 and 08/2020 were reviewed. Only patients with normal function of the affected extremity and the contralateral side before trauma were eligible for this study. Subjects with previous shoulder or upper arm surgery on either side were excluded. The remaining candidates were contacted and informed about the study. Only volunteers >18 years of age agreeing to undergo functional testing and MRI imaging of both shoulders and upper arm at least 12 months following surgery were included. At least 1 year after surgery, patient-reported outcome measures (PROMs), functional results and MR imaging of both shoulders down to the deltoid tuberosity were obtained and compared to the contralateral uninjured side.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	All measured at least 1 year postoperatively, time range 12-48 months: 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). 2. Imaging of the deltoid muscle and its distal insertion performed by MR imaging (1.5T MRI scanner [Ingenia, Philips Healthcare, Best, the Netherlands])
Key secondary outcome measure(s)	All measured at least 1 year postoperatively, time range 12-48 months: 1. Overall shoulder function measured using the Constant-Murley Score (CMS) and gender- and age-adapted CMS 2. Shoulder pain and function measured using the Oxford Shoulder Score (OSS) 3. Upper-extremity disability and symptoms measured using the Disabilities for the Arm, Shoulder, and Hand (DASH) outcome measure 4. Patient's self-rated health measured using EQ-5D-5L visual analogue score (VAS) 5. Mobility, self-care, usual activities, pain and anxiety/depression measured using EQ-5D-5L
Completion date	10/12/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	6
Total final enrolment	6
Key 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
Key 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
Date of first enrolment	01/03/2017
Date of final enrolment	30/08/2020

Locations

Countries of recruitment

Switzerland

Study participating centre

Cantonal Hospital Winterthur

Brauerstrasse 15
Winterthur
8302
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and analysed during the current study will be available upon request from Christoph Meier (christoph.meier@ksw.ch). Complete datasets will be available upon publication of the study. Informed consent was obtained from all patients. The authors had access to information that could identify individual participants during or after data collection. However, the two senior radiologists who analysed the MR images had no access to any clinical data concerning the shoulder function of the participating patients.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		08/11/2023	08/11/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

08/11/2023: Publication reference added.
26/05/2023: Study's existence confirmed by Kantonale Ethikkommission Kanton Zürich.