Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988541
• Other study ID #: Tikk2023
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: Tartu University Hospital
• Contact: Tiina Tikk, MD
• Phone: 55929399
• Email: tiinatikk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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.
• 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).
• 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).
• 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.

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu	Tartumaa

Sponsors (2)

Lead Sponsor	Collaborator
Tartu University Hospital	University of Tartu

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasonography	Integrity of the rotator cuff tendons	5 years after primary repair
Secondary	American Shoulder and Elbow Surgeons (ASES) score	The higher the score, the better the outcome.	5 years after primary repair
Secondary	Constant-Murley score (CMS)	The higher the score, the higher the quality of the function.	5 years after primary repair
Secondary	The Disabilities of the Arm, Shoulder and Hand (DASH)	The higher the score, more severe disability.	5 years after primary repair