Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.

Overview of Surgically Treated Rotator Cuff Injury Patients and Rotator Cuff Integrity 5 Years After Atraumatic Rotator Cuff Tendon Repair.

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).

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Injuries; Rotator Cuff Tear or Rupture, Not Specified as Traumatic; Rotator Cuff Tears
• Intervention / Treatment: 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); Diagnostic test: Ultrasonography imaging

Detailed Description

High numbers of re-tear after rotator cuff surgery have been shown, though not always influencing patient satisfaction. If there is an atraumatic tendon tear, the risk of having a contralateral rotator cuff tendon tear is high.

The aim is to study surgically treated rotator cuff injury patients 5 years after repair to evaluate tendon integrity on ultrasonography and answer the question do the findings correlate with functionality and patient satisfaction. It has been shown that people over the age of 66 who have been diagnosed with rotator cuff tendon tear, have up to 50 % chance of having a rotator cuff tendon tear in contralateral shoulder (Yamaguchi, et al. 2006). Therefore the study will evaluate the function and the integrity of the rotator cuff in both shoulders.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Estonia
  • Tartumaa
    • Tartu, Tartumaa, Estonia, 50410
      • Tartu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Atraumatic rotator cuff tendon repair; Ultrasonography imaging of the operated shoulder	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).; 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).; Instability section: 2 questions (1. Response yes/no about feelings of instability, 2. Quantify instability from 0 (stable) to 10 (very unstable)).; 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.; 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.
Other: Contralateral shoulder; Ultrasonography imaging of the contralateral shoulder	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).; 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).; Instability section: 2 questions (1. Response yes/no about feelings of instability, 2. Quantify instability from 0 (stable) to 10 (very unstable)).; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasonography	Integrity of the rotator cuff tendons	5 years after primary repair

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons (ASES) score	The higher the score, the better the outcome.	5 years after primary repair
Constant-Murley score (CMS)	The higher the score, the higher the quality of the function.	5 years after primary repair
The Disabilities of the Arm, Shoulder and Hand (DASH)	The higher the score, more severe disability.	5 years after primary repair

Collaborators and Investigators

• Sponsor: Tartu University Hospital
• Collaborators: University of Tartu
• Investigators: Principal Investigator: Tiina Tikk, MD, Tartu University

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: sonography; rotator cuff injury; rotator cuff tears; shoulder injuries; atraumatic tears; shoulder pathology; shoulder ultrasound
• Additional Relevant MeSH Terms: Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Rupture; Wounds and Injuries
• Other Study ID Numbers: Tikk2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No