Comparing surgical and conservative treatments for rotator cuff tears

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12733667

Enrollment

Registered

2019-05-01

Start date

2021-01-07

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff tears Musculoskeletal Diseases Rotator cuff syndrome

Interventions

Surgical treatment: Patients in group 1 will undergo an arthroscopic rotator cuff repair Conservative treatment: Conservative treatment will consist of

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Italy

Contacts

Public ContactUmile Giuseppe Longo

g.longo@unicampus.it+3906225418816

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026