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 |
| Secondary identifying numbers | BASEC Nr.: 2021-00811 |
- 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
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
Public
Cantona Hospital Winterthur
Brauerstrasse 15
Winterthur
8401
Switzerland
 ORCID ID |
0000-0001-6944-9648 |
|---|---|
| Phone | +41 (0)522662411 |
| christoph.meier@ksw.ch |
Scientific
Cantona Hospital Winterthur
Brauerstrasse 15
Winterthur
8401
Switzerland
| Phone | +41 (0)522662411 |
|---|---|
| christoph.meier@ksw.ch |
Principal Investigator
Cantona Hospital Winterthur
Brauerstrasse 15
Winterthur
8401
Switzerland
| Phone | +41 (0)5222662411 |
|---|---|
| christoph.meier@ksw.ch |
Study information
| Study design | Observational case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a 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 | 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]) |
| Secondary outcome measures | 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 |
| Overall study start date | 01/02/2021 |
| Completion date | 10/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
Winterthur
8302
Switzerland
Sponsor information
Hospital/treatment centre
Clinic for Orthopaedics and Traumatology
Brauerstrasse 15
Winterthur
8401
Switzerland
| Phone | +41 (0)52 266 24 25 |
|---|---|
| Emanuel.benninger@ksw.ch | |
| Website | http://ksw.ch |
"ROR" |
https://ror.org/014gb2s11 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/08/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study is completed and a manuscript written. The study is ready to be submitted for publication in a peer-reviewed scientific journal. |
| 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 |
Editorial Notes
08/11/2023: Publication reference added.
26/05/2023: Study's existence confirmed by Kantonale Ethikkommission Kanton Zürich.
