Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.

NACompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

October 3, 2023

Primary Completion Date

September 1, 2024

Study Completion Date

September 1, 2024

Conditions
Rotator Cuff TearsRotator Cuff InjuriesRotator Cuff Tear or Rupture, Not Specified as Traumatic
Interventions
DIAGNOSTIC_TEST

Ultrasonography imaging

Ultrasonography: rotator cuff tendons (supraspinatus, infraspinatus, subscapularis) integrity, long head of the biceps tendon integrity and location, SASD (subacromial-subdeltoid) bursitis, synovitis and muscle atrophy.

DIAGNOSTIC_TEST

American Shoulder and Elbow Surgeons (ASES) Score

"The patient self-assessment (pASES) includes 6 pain items and 10 functional items that are shoulder specific (Angst, 2008).~The pASES form has 3 sections: pain, instability, ADLs (Goldhahn, 2008).~1. Pain section: 4 questions with yes/no responses, 1 question covering number of pain tablets per day, and a VAS (visual analogue scale) from 0 (no pain) to 10 (worst pain).~2. Instability section: 2 questions (1. Response yes/no about feelings of instability, 2. Quantify instability from 0 (stable) to 10 (very unstable)).~3. Activities of daily living (ADLs): Each shoulder is included (affected/non affected), 10 items, with a 4 point ordinal scale, range: 0 (unable to perform activity) to 3 (no difficulty in doing activity) (Goldhahn 2008)."

DIAGNOSTIC_TEST

The Constant-Murley score (CMS)

The test is divided into four subscales: pain (15 points), activities of daily living (ADL) (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points).

DIAGNOSTIC_TEST

The Disabilities of the Arm, Shoulder and Hand (DASH)

"30-item self-report questionnaire designed to assess symptoms and function of the entire upper extremity.~Total scores range from 0 (minimum) to (100) maximum."

Trial Locations (1)

50410

Tartu University Hospital, Tartu

All Listed Sponsors
collaborator

University of Tartu

OTHER

lead

Tartu University Hospital

OTHER

NCT05988541 - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair. | Biotech Hunter | Biotech Hunter