Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.

Summary

The study gives an overview of surgically treated rotator cuff injury patients in Tartu University Hospital Sports Traumatology Centre during 2013-2019 and evaluates the integrity of rotator cuff at minimum 5 years after atraumatic rotator cuff tendon repair.

First stage of the study describes the study population, etiology of the injury (traumatic/atraumatic) and aims to answer the question whether the arthroscopic findings are in line with the preoperative imaging studies or not.

Second stage of the study focuses on atraumatic tendon tears assessing structural integrity of the tendons 5 years after repair using ultrasound imaging. The main question is - does the findings correlate with clinical outcomes and patient satisfaction.

Participants of the second phase of the study will be asked for an appointment to have their shoulders examined with ultrasonography and clinical outcomes are measured using the American Shoulder and Elbow Surgeons (ASES) Score, The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and The Constant-Murley score (CMS).

Conditions

• Rotator Cuff Tears
• Rotator Cuff Injuries
• Rotator 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.

Sponsors & Collaborators

• University of Tartu

  collaborator OTHER

• Tartu University Hospital

  lead OTHER

Principal Investigators

• Tiina Tikk, MD · University of Tartu

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-03

Primary Completion

2024-09-01

Completion

2024-09-01

Countries

• Estonia

Study Locations