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NCT Number: NCT05988541

Rotator Cuff Integrity and Clinical Outcomes 5 Years After 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).

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rotator Cuff Tear or Rupture, Not Specified as Traumatic Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tartu University Hospital

Tartu, 50410, Estonia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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).

  • 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).

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).

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.

Primary outcomes

  1. Ultrasonography

    Time frame: 5 years after primary repair

    Integrity of the rotator cuff tendons

Secondary outcomes

  1. American Shoulder and Elbow Surgeons (ASES) score

    Time frame: 5 years after primary repair

    The higher the score, the better the outcome.

  2. Constant-Murley score (CMS)

    Time frame: 5 years after primary repair

    The higher the score, the higher the quality of the function.

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

    Time frame: 5 years after primary repair

    The higher the score, more severe disability.

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Collaborators

  • University of Tartu

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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