Clinical trial NCT05988541: Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.
Official title: Overview of Surgically Treated Rotator Cuff Injury Patients and Rotator Cuff Integrity 5 Years After Atraumatic Rotator Cuff Tendon Repair.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
Collaborators: name: University of Tartu
First posted: 2023-08-14
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Ultrasonography
timeFrame: 5 years after primary repair
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) score
timeFrame: 5 years after primary repair
measure: Constant-Murley score (CMS)
timeFrame: 5 years after primary repair
measure: The Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: 5 years after primary repair
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
state: Tartumaa
Study officials:
affiliation: Tartu University
name: Tiina Tikk, MD
role: PRINCIPAL_INVESTIGATOR
References: