Tailored postoperative care for rotator cuff pathologies

Not Applicable

• Conditions: Rotator cuff tears; Musculoskeletal Diseases

• Registration Number: ISRCTN10282273
• Lead Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-03
• Last Update Posted: 16 October 2023
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Age 45-70 years.
2. Atraumatic, symptomatic, isolated full-thickness supraspinatus tendon tear 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.

Exclusion Criteria

1. Frozen shoulder.
2. Radiological osteoarthritis of the glenohumeral joint.
3. Neurological disease or language barriers.
4. Acute-on-chronic tears (after a traumatic event in a shoulder with preceding episodes of symptoms).
5. Impossibility to undergo MRI scan for any reason.
6. Tear involving the whole supraspinatus tendon combined with a tear of two or three tendons.
7. Muscle fatty degeneration > of stage 2 according to Goutallier classification
8. Muscle atrophy evaluated with Tangent sign, exceeding stage 2.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Before surgery and at 6-months and 12-months after surgery:<br>1. Structural data are measured by structural evaluation (MRI)<br>2. Kinematic variables (such as range of motion, angular velocity) are measured by kinematic analysis<br>

Secondary Outcome Measures

Name	Time	Method
Clinical data evaluated before surgery and at 6-weeks, 3-months, 6- months, and 12-months after surgery:<br>1. Physical and subjective measures of the affected shoulder in terms of pain, activities of daily living (ADL), range of motion (ROM), and strength are measured by CMS.<br>2. Patient self-reported and clinician scores about pain, ADL, ROM, signs, strength, and instability are measured by ASES.<br>3. The quality of life and mental health (such as physical and social functioning, general health perception limitations due to emotional aspects, vitality) are measured by SF-36. <br>4. The level of pain perceived by patients are measured by VAS.