Precision medicine and personalized care in patients with rotator cuff disease: future perspectives and new frontiers using machine learning models
| ISRCTN | ISRCTN13188760 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13188760 |
- Submission date
- 16/10/2023
- Registration date
- 24/11/2023
- Last edited
- 08/05/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Rotator cuff (RC) tear is one of the most common shoulder injuries that causes pain and severe limitations in performing activities of daily living. Surgical procedures represent the best treatment option in patients with symptomatic RC tears and severe dysfunction of shoulder movement but the risk of retear remains a major postoperative drawback. The incidence of retear is influenced by biological, genetic and biomechanical factors. In the last years, machine learning has been a tool of strong interest in clinical medicine. In the orthopedics field, little discussion has revolved around how to apply these tools for the early prediction of surgical treatments and personalized care of RC patients.
The aim of the study is to create a pre- and post-operative database with clinical, structural, genetic, and kinematic data from RC patients. In addition, by developing a new machine learning model, pre-operative data will be able to predict clinical and structural outcomes, suggesting new insights for treatment of RC tears.
Who can participate?
Patients aged 40-75 years at Fondazione Policlinico Universitario Campus Bio-Medico with rotator cuff tears
What does the study involve?
An experienced orthopedic surgeon will perform surgical procedures on all patients. Patients will undergo pre- and post-surgical (12-month) follow-up visits which will include assessments, MRI scans, and blood and tissue samples taken during surgery for genetic analysis. The total duration of the study is 48 months.
What are the possible benefits and risks of participating?
There are no risks for the patients recruited in the study.
Where is the study run from?
Fondazione Policlinico Universitario Campus Bio-Medico (Italy)
When is the study starting and how long is it expected to run for?
January 2023 to January 2027
Who is funding the study?
PNRR (National Recovery and Resilience Plan): M6/C2_CALL 2022. This research was supported by EU funding within the NextGenerationEU - Italian Ministry of Health PNRR (Project no. PNRR-MAD-2022-12376080) - CUP: F83C22002450001
Who is the main contact?
Prof. Umile Giuseppe Longo, g.longo@policlinicocampus.it
Contact information
Public, Scientific, Principal Investigator
Via Álvaro Del Portillo, 200
Roma
00128
Italy
 ORCID ID |
0000-0003-4063-9821 |
|---|---|
| Phone | +39 (0)6225418816 |
| g.longo@policlinicocampus.it |
Study information
| Study design | Interventional prospective monocentric study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Quality of life, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A multimodal machine learning approach for precision medicine and personalized care of patients with rotator cuff diseases |
| Study acronym | PREDICT-CUFF |
| Study objectives | The main hypothesis is that preoperative data can predict clinical and structural outcomes by defining new reliable features, which in turn may suggest new insights for rotator cuff (RC) tear treatment. |
| Ethics approval(s) |
1. Approved 30/01/2023, Comitato Etico Fondazione Policlinico Universitario Campus Bio-Medico (Via Álvaro del Portillo, 21, Roma, 00128, Italy; +39 (0)6225418812; comitato.etico@policlinicocampus.it), ref: PAR 04.23 2. Approved 30/05/2023, Comitato Etico Fondazione Policlinico Universitario Campus Bio-Medico (Via Álvaro del Portillo, 21, Roma, 00128, Italy; +39 (0)6225418812; comitato.etico@policlinicocampus.it), ref: 001.23(04.23) |
| Health condition(s) or problem(s) studied | Rotator cuff tears |
| Intervention | An experienced orthopedic surgeon will perform surgical procedures on all the enrolled patients after obtaining consent for the study participation. The arthroscopic RC repair will be performed by placing one row of double-loaded suture anchors. Enrolled patients will undergo pre- and post-surgical (12 months) follow-up visits during which the staff in charge will perform clinical-functional assessments, administration of clinical scores, MRI evaluation, and kinematic analysis using a stereophotogrammetric system. In addition, blood and tissue samples required for subsequent genetic analysis will be taken during surgery. |
| Intervention type | Mixed |
| Primary outcome measure | Structural tendon integrity, as evidenced by MRI evaluations at 12 months after surgery |
| Secondary outcome measures | Measured before and after surgery: 1. Kinematic variables (such as range of motion, angular velocity) measured by kinematic analysis 2. Physical and subjective measures of the affected shoulder in terms of pain, activities of daily living (ADL), range of motion (ROM), and strength measured by the Constant-Murley score (CMS) 3. Patient self-reported and clinician scores about pain, ADL, ROM, signs, strength, and instability measured by the American Shoulder and Elbow Surgeons (ASES) score 4. Quality of life and mental health (such as physical and social functioning, general health perception limitations due to emotional aspects, vitality) measured by SF-36 5. The level of pain perceived by patients measured by visual analogue score (VAS) |
| Overall study start date | 01/01/2023 |
| Completion date | 31/01/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 40 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Age 40-75 years 2. Rotator cuff tears documented with MRI 3. No surgical treatment to the affected shoulder before 4. No episodes of shoulder instability 5. No radiographic signs of fracture of the glenoid fossa or the greater or lesser tuberosity |
| Key exclusion criteria | 1. Frozen shoulder 2. Radiological osteoarthritis of the glenohumeral joint 3. Neurological disease or language barriers 4. Impossibility to undergo an MRI scan for any reason |
| Date of first enrolment | 01/01/2024 |
| Date of final enrolment | 31/01/2026 |
Locations
Countries of recruitment
- Italy
Study participating centre
Roma
00128
Italy
Sponsor information
Hospital/treatment centre
via Alvaro del portillo 200
Roma
00128
Italy
| Phone | +39 (0)6225419167 |
|---|---|
| comitato.etico@policlinicocampus.it | |
| Website | https://www.policlinicocampusbiomedico.it/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Dedicated personnel will develop a centralized web-based database. The e-infrastructure will be managed by authorized and authenticated access by users, who will be able to upload data and view patient information. Specific procedures for anonymity and protection of sensitive subject data will be implemented. In addition, the PI will organize monthly meetings to verify the reliability and accuracy of the collected data. Patients who meet the inclusion criteria and have expressed an interest in participating will be asked to provide dated and signed informed consent. All participants will be assigned a unique identification code. No information identifying the participant in any way will be disseminated. The database will be anonymized through the use of the unique identification code associated with each subject recruited and managed with appropriate protection systems; demographic data identifying each patient will be stored in a separate spreadsheet available only to the study responsibles or their delegates. The database generated during and/or analyzed during the current study are not expected to be made available due to the sensitivity of patient data. |
Editorial Notes
08/05/2024: The following changes were made to the trial record:
1. The funder type was changed from Hospital/teatment centre to Government and the funder names Fondazione Policlinico Universitario Campus Bio-Medico and Italian Ministry of Health were removed
2. The plain English summary was updated to reflect these changes.
23/10/2023: Study's existence confirmed by the Comitato Etico Fondazione Policlinico Universitario Campus Bio-Medico.
