Prognostic model for the determination of clinical outcome of shoulder fractures at 1 year after initial treatment
| ISRCTN | ISRCTN57410678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57410678 |
| Secondary identifying numbers | ΕΗΔΕ 13298 |
- Submission date
- 13/03/2022
- Registration date
- 22/03/2022
- Last edited
- 22/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Proximal humeral (shoulder) fractures are very common and account for 4% to 5% of all fractures seen in the average orthopedic clinic. Incidence increases with age and decreasing bone quality (i.e., osteoporosis). Stable proximal humeral fractures with minimal displacement are generally treated without surgery, whereas the majority of the unstable and displaced fractures require surgical treatment. The indications for selecting a specific treatment from the wide variety of available procedures remain controversial regardless of the fracture type. A great variety of options is available for the fixation of these fractures. However, all of them suffer from a persistently substantial rate of mechanical failure as well as a number of other complications, including decreased range of motion and poor functional outcomes. Patient age and sex, fracture type, other injuries and factors such as bone quality and blood supply to the fragments, influence the treatment chosen and its prognosis. The key may be to choose the most appropriate fixation method according to the exact patient and fracture characteristics based on clearly defined indications and contraindications. Currently there is not enough evidence to distinguish and measure the effect of a range of prognostic factors known to directly or indirectly influence the functional outcome of patients with proximal humeral fractures. The aim of this study is to develop a prognostic model for determining the functional outcome based on the minimum 1-year patient-reported outcome scores (quick-DASH and SPALDI) after conservative or surgical treatment.
Who can participate?
Patients aged 18 years and over with displaced two-, three-, and four-part fractures of the proximal humerus
What does the study involve?
The medical records of all patients with proximal humeral fractures who were admitted or followed up from 2000 to 2020 will be assessed and constitute the initial database. The patients will be re-examined at a minimum of 1-year follow-up clinically using quick-DASH and SPADI scores and by x-rays. Thirteen possible factors (age, gender, dominant side, other illnesses, fracture type, viability of the humeral head, presence of dislocation, type of intervention [conservative or surgical], type of internal fixation (plate or sutures), physiotherapy, intraoperative complications, later complications, final radiological parameters and length of follow up) will be tested to determine their final prognostic value on the functional outcome.
What are the possible benefits and risks of participating?
These data will help the orthopaedic surgeon to better understand the complexity of the injury, suggest appropriate patient- and fracture-specific treatment options and improve operative techniques and interventions. There are no other risks for patients during their evaluation with the clinical scores at 1 year.
Where is the study run from?
Patras University Hospital (Greece)
When is the study starting and how long is expected to run for?
January 2020 to January 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Andreas Panagopoulos
anpanagop@upatras.gr
Contact information
Principal Investigator
Orthopedic Department, Patras University Hospital
Papanikolaou 1, 1st floor
Patras
26504
Greece
 ORCID ID |
0000-0002-8215-9327 |
|---|---|
| Phone | +30 (0)6944363624 |
| anpanagop@upatras.gr |
Study information
| Study design | Single-center retrospective interventional outcome study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format |
| Scientific title | Prognostic value of different patient, injury or treatment-related factors at the 1-year functional outcome of proximal humerus fractures using the quick-DASH and SPALDI scores |
| Study acronym | PRO.MO.FPH |
| Study objectives | In the present study, the technique of path analysis will be used to develop a prognostic model for determining the functional outcome, based on the 1-year Disabilities of Arm, Shoulder and Hand (Quick-DASH score) and Shoulder Pain and Disability Index (SPADI score) for displaced proximal humeral fractures in patients treated either conservative or with open reduction and internal fixation (plate or transosseous suturing) in a single University Hospital in order to analyze the complex inter-relationships between various patients-related, surgeon-related and injury-related factors and their effect on the final outcome. The initial hypothesis is that all 14 factors would be related to the functional outcome at 1 year. |
| Ethics approval(s) | Approved 18/02/2020, ethics committee of Patras University (Rio 26504, Greece, +30 (0)26130997841; ehde@upatras.gr), ref: ΕΔΗΕ 13298 |
| Health condition(s) or problem(s) studied | Fractures of the proximal humerus |
| Intervention | 1. Surgical treatment of proximal humeral fractures with either a plate or transosseous sutures 2. Conservative treatment of proximal humerus fractures The medical records of all patients with proximal humeral fractures admitted or followed up from 2000 to 2021 will be assessed and constitute the initial database. Only patients with full details of their medical record and pre- and post-operative radiographs will be included in the study. After informed consent the patients will be re-examined at a minimum of 1 year follow up clinically using quick-DASH and SPADI scores and radiographically. Thirteen hypothetic causal inter-relationship factors (age, gender, dominant side, comorbidities, fracture type, viability of humeral head, presence of dislocation, type of intervention [conservative or surgical], type of internal fixation [plate or sutures], physiotherapy protocol, intraoperative complications, later complications, final radiological parameters and length of follow up) will be tested to determine their final prognostic value on the functional outcome. The hypothetical causal path diagram will represent the initial hypothesis based on current knowledge, whereas the final path diagram will be a refinement of the hypothesis using available observational data. These data will help the orthopaedic surgeon to better understand the complexity of the injury, suggest appropriate patient- and fracture-specific treatment options and improve operative techniques and interventions. Observational databases can be used as a tool to analyze complex inter-relationships among patient, injury, and treatment factors and their relative effects on outcomes. Multivariable regression analyses are traditionally used to identify the most likely important prognostic factors and to quantify their strength of association with the outcome. In the context of a path analysis, this method presents a visual perspective of the associations among factors and the outcome. One of the strengths of this type of analysis is that prior knowledge of the most likely causal factors along with their temporal relationships is fundamental. The developed model must be clinically relevant and reflect the reality of the phenomena under study as much as possible. Patient age and sex, fracture type, concomitant injuries, and biologic factors, influence the type of therapeutic intervention chosen and its prognosis. Yet the results are mostly derived from univariable analyses of low volume studies. To date, there are no current studies that clearly distinguish and measure the effect of a range of postulated prognostic factors known to directly or indirectly influence the functional outcome of patients with proximal humeral fractures. The objective of this analysis is to test the hypothetic causal inter-relationships among 12 different factors potentially having a direct influence on the functional DASH and SPADI scores after proximal humeral fractures at minimum 1-year follow up. The hypothetic causal path diagram will represent the initial hypothesis based on current knowledge, whereas the final path diagram will be a refinement of the hypothesis using available observational data. These data will help the orthopaedic surgeon to better understand the complexity of the injury, to suggest appropriate “patient- and fracture-specific” treatment options and to improve operative techniques and interventions. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Clinical outcome measured with the Disabilities of Arm, Shoulder and Hand (Quick-DASH score) and the Shoulder Pain and Disability Index (SPANDI score) in 3, 6 and 12 months following the initial treatment |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 10/01/2020 |
| Completion date | 10/01/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 700 |
| Total final enrolment | 400 |
| Key inclusion criteria | 1. At least 18 years old 2. Displaced two-, three-, and four-part fractures of the proximal humerus according to Neer’s classification (displacement >1 cm or angulation >45 degrees) 3. Complete medical records (including full series of pre- and post-operative x-rays) |
| Key exclusion criteria | 1. Nonunion 2. Pathologic fractures 3. Re-fractures 4. Non-displaced fractures 5. Open fractures 6. Concomitant ipsilateral fractures of the upper limb requiring surgery 7. Multiple trauma patients 8. Major nerve or vascular injury 9. Severe dislocation or head splitting component 10. Rotator cuff tear arthropathy or severe rotator cuff insufficiency 11. Severe dementia and/or institutionalization 12. Inability to understand written and spoken guidance in Greek |
| Date of first enrolment | 01/03/2021 |
| Date of final enrolment | 01/03/2023 |
Locations
Countries of recruitment
- Greece
Study participating centre
Papanikolaou 1, Rio
Patras
26504
Greece
Sponsor information
Hospital/treatment centre
Papanikolaou 1
Pátrai
26504
Greece
| Phone | +30 (0)2613603551 |
|---|---|
| orthosecr@med.upatras.gr | |
| Website | http://www.pgnp.gr/ |
"ROR" |
https://ror.org/03c3d1v10 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 10/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Publication of the protocol and the results in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current study will be published as a supplement to the results publication |
Editorial Notes
21/03/2022: Trial's existence confirmed by the ethics committee of Patras University.
