Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.

NCT05988541 | Completed

• 1 other identifier: Tikk2023
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rotator cuff injury; rotator cuff tears; sonography; shoulder injuries; atraumatic tears; shoulder pathology; shoulder ultrasound

Outcome Measures

Primary Outcomes (1)

• Ultrasonography

  Integrity of the rotator cuff tendons

  5 years after primary repair

Secondary Outcomes (3)

• American Shoulder and Elbow Surgeons (ASES) score

  5 years after primary repair

• Constant-Murley score (CMS)

  5 years after primary repair

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

  5 years after primary repair

Study Arms (2)

Atraumatic rotator cuff tendon repair

OTHER

Ultrasonography imaging of the operated shoulder

Diagnostic Test: Ultrasonography imaging; Diagnostic Test: American Shoulder and Elbow Surgeons (ASES) Score; Diagnostic Test: The Constant-Murley score (CMS); Diagnostic Test: The Disabilities of the Arm, Shoulder and Hand (DASH)

Contralateral shoulder

OTHER

Ultrasonography imaging of the contralateral shoulder

Diagnostic Test: Ultrasonography imaging; Diagnostic Test: American Shoulder and Elbow Surgeons (ASES) Score; Diagnostic Test: The Constant-Murley score (CMS); Diagnostic Test: The Disabilities of the Arm, Shoulder and Hand (DASH)

Interventions

Ultrasonography imaging DIAGNOSTIC_TEST

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.

Atraumatic rotator cuff tendon repair; Contralateral shoulder

American Shoulder and Elbow Surgeons (ASES) Score DIAGNOSTIC_TEST

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).

Atraumatic rotator cuff tendon repair; Contralateral shoulder

The Constant-Murley score (CMS) DIAGNOSTIC_TEST

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).

Atraumatic rotator cuff tendon repair; Contralateral shoulder

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

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.

Atraumatic rotator cuff tendon repair; Contralateral shoulder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients underwent rotator cuff repair by three orthopaedic surgeons at the Tartu University Hospital Sports Traumatology Centre between 2013 and 2019.
• Subject gives an informed consent and is willing to come for one outpatient visit.

You may not qualify if:

• Patients who underwent rotator cuff repair for traumatic tears are excluded from clinical assessment (stage II).
• Patients who underwent revision surgery are excluded from clinical assessment (stage II).

Sponsors & Collaborators

• Tartu University Hospital: lead
• University of Tartu: collaborator

Study Sites (1)

Tartu University Hospital

Tartu, Tartu, 50410, Estonia

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Rupture; Shoulder Injuries

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Tiina Tikk, MD

  University of Tartu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: October 3, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)