Condition category
Musculoskeletal Diseases
Date applied
19/01/2019
Date assigned
01/05/2019
Last edited
01/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Prof Umile Giuseppe Longo

ORCID ID

http://orcid.org/0000-0003-4063-9821

Contact details

via alvaro del portillo 200
rome
00128
Italy
+3906225418816
g.longo@unicampus.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19/18 PAR ComEt CBM

Study information

Scientific title

Surgical versus conservative management for patients with rotator cuff tears: a randomized controlled trial

Acronym

SUN

Study hypothesis

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

University Campus Bio-Medico of Rome Ethic Committee, 29/03/2018, ref. 19/18 PAR ComEt CBM.

Study design

Randomised Controlled Trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not Available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

Primary outcome measure

Pain and ability to carry out normal daily activities will be measured using the constant score at 6, 12, and 24 months.

Secondary outcome measures

1. Shoulder function will be measured using the ASES Shoulder Score at 6, 12, and 24 months
2. Pain will be measured using the VAS at 6, 12, and 24 months.
3. Patient-reported outcomes will be measured using the Oxford Shoulder Score at 6, 12, and 24 months.
4. Rotator cuff integrity, the extent of fatty degeneration and the amount of muscle atrophy will be measured using an MRI at 6, 12 and 24 months post-operatively.
5. Shoulder pain and disability will be measured using the Shoulder Pain And Disability Index at 6, 12, and 24 months.
6. Pain-related disability will be measured using the Shoulder Disability Questionnaire at 6, 12, and 24 months.
7. Shoulder symptoms and function will be measured using the Shoulder Rating Questionnaire at 6, 12, and 24 months.
8. General health will be measured using the Short-Form 36 at 6, 12, and 24 months.

Overall trial start date

01/01/2016

Overall trial end date

31/12/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Atraumatic, symptomatic, isolated full-thickness supraspinatus tendon tear documented with MRI
2. Full passive range of motion of the shoulder.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Participant 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)

Recruitment start date

20/05/2019

Recruitment end date

10/02/2022

Locations

Countries of recruitment

Italy

Trial participating centre

University Campus Bio-Medico of Rome
via alvaro del portillo 200
rome
00128
Italy

Sponsor information

Organisation

Campus Bio-Medico University of Rome

Sponsor details

via alvaro del portillo 200
rome
00128
Italy
+3906225419167
g.longo@unicampus.it

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Università Campus Bio-Medico di Roma

Alternative name(s)

Campus Bio-Medico University

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Italy

Funder name

Italian Ministry of Health (Ricerca Finalizzata)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2023

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes