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Tailored postoperative care for rotator cuff pathologies

Tailored postoperative care for rotator cuff pathologies: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10282273
Enrollment
100
Registered
2023-10-03
Start date
2023-12-21
Completion date
Unknown
Last updated
2026-02-02

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

Interventions

After the enrollment of all the patients satisfying the inclusion criteria and after obtaining consent for the study participation, patients will undergo structural evaluation (MRI), kinematic analysi

Sponsors

Fondazione Policlinico Universitario Campus Bio-Medico
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Clinical data evaluated before surgery and at 6-weeks, 3-months, 6- months, and 12-months after surgery: 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. 2. Patient self-reported and clinician scores about pain, ADL, ROM, signs, strength, and instability are measured by ASES. 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. 4. The level of pain perceived by patients are measured by VAS.

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026