Comparing surgical and conservative treatments for rotator cuff tears
| ISRCTN | ISRCTN12733667 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12733667 |
| Protocol serial number | 19/18 PAR ComEt CBM |
| Sponsor | Campus Bio-Medico University of Rome |
| Funders | Università Campus Bio-Medico di Roma, Italian Ministry of Health (Ricerca Finalizzata) |
- Submission date
- 19/01/2019
- Registration date
- 01/05/2019
- Last edited
- 03/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Rotator cuff (RC) disease is among the most common musculoskeletal disorders. Patients with RC pathology may complain of symptoms ranging from minimal discomfort without functional deficits to severe pain, weakness, and marked disability. The aim of this study is to compare surgical and conservative treatment of RCT, in term of functional outcomes, rotator cuff (RC) integrity, and muscle atrophy or fatty degeneration, to evaluate treatment effectiveness and obtain high-quality evidence for the management of those patients.
Who can participate?
Patients of aged 18 or over with atraumatic, symptomatic, isolated full-thickness supraspinatus tendon tear documented with MRI; full range of motion of the shoulder.
What does the study involve?
To be randomized to surgical and conservative treatment of degenerative RCT.
What are the possible benefits and risks of participating?
It is hoped that the insight gained will help to inform how best to approach RC disease. The results will be published to inform further research into the effectiveness of rehabilitation versus surgical repair of the RC. No additional risks to participants in either treatment group are anticipated.
Where is the study run from?
University Campus Bio-Medico of Rome- Italy.
When is the study starting and how long is it expected to run for?
May 2019 until April 2022.
Who is funding the study?
University Campus Bio-Medico of Rome and the Italian Ministry of Health ((Ricerca FINALIZZATA 2016 - PE-2016-02364894).
Who is the main contact?
Prof Umile Giuseppe Longo
G.Longo@unicampus.it
Contact information
Public
via alvaro del portillo 200
rome
00128
Italy
 ORCID ID |
0000-0003-4063-9821 |
|---|---|
| Phone | +3906225418816 |
| g.longo@unicampus.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised Controlled Trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Surgical versus conservative management for patients with rotator cuff tears: a randomized controlled trial |
| Study acronym | SUN |
| Study objectives | There will be no differences between surgical and conservative treatment of rotator cuff tears, in term of functional outcomes, rotator cuff integrity, and muscle atrophy or fatty degeneration. |
| Ethics approval(s) | University Campus Bio-Medico of Rome Ethic Committee, 29/03/2018, ref. 19/18 PAR ComEt CBM. |
| Health condition(s) or problem(s) studied | Rotator Cuff tears |
| Intervention | Surgical treatment: Patients in group 1 will undergo an arthroscopic rotator cuff repair Conservative treatment: Conservative treatment will consist of a validated protocol for conservative RC rehabilitation (http://www.moonshoulder.com/booklets/060109PatientRehabBooklet.pdf) under the supervision of an experienced shoulder physiotherapist. Total duration of treatment: 3 months Follow-up for all study arms Follow up at 6, 12, and 24 months Details of the randomisation process: Patients will be randomly assigned to surgical repair (Group 1) or conservative treatment (Group 2) using a computer-generated allocation, stratified for age, gender, and affected shoulder (right or left). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Pain and ability to carry out normal daily activities will be measured using the constant score at 6, 12, and 24 months. |
| Key secondary outcome measure(s) |
1. Shoulder function will be measured using the ASES Shoulder Score at 6, 12, and 24 months |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 98 |
| Key inclusion criteria | 1. Atraumatic, symptomatic, isolated full-thickness supraspinatus tendon tear documented with MRI 2. Full passive range of motion of the shoulder. |
| Key exclusion criteria | 1. Previous surgical treatment of the shoulder 2. Frozen shoulder 3. Radiological osteoarthritis of the glenohumeral joint 4. Cognitive disorders 5. Neurological disease or language barriers 6. Tear involving the whole supraspinatus tendon combined with tear of two to three tendons 7. Muscle fatty degeneration > of stage 2 according to Goutallier classification 8. Muscle atrophy evaluated with Tangent sign, exceeding stage 2 9. Acute-on-chronic tears (after a traumatic event in a shoulder with preceding episodes of symptoms) |
| Date of first enrolment | 07/01/2021 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- Italy
Study participating centre
rome
00128
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/03/2022: The following changes have been made:
1. The recruitment start date has been changed from 20/05/2019 to 07/01/2021.
2. The recruitment end date has been changed from 10/02/2022 to 31/12/2024.
3. The overall trial end date has been changed from 31/12/2022 to 31/12/2024 and the plain English summary has been updated to reflect this change.
4. The intention to publish date has been changed from 31/12/2023 to 01/01/2025.
5. The target number of participants has been changed from 130 to 98 and the total target enrolment has been changed from 130 to 98.
