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Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.

Not Applicable
Recruiting
Conditions
Rotator Cuff Tears
Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Rotator Cuff Injuries
Interventions
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)
Registration Number
NCT05988541
Lead Sponsor
Tartu University Hospital
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
150
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.
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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).
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Atraumatic rotator cuff tendon repairUltrasonography imagingUltrasonography imaging of the operated shoulder
Atraumatic rotator cuff tendon repairThe Disabilities of the Arm, Shoulder and Hand (DASH)Ultrasonography imaging of the operated shoulder
Contralateral shoulderThe Disabilities of the Arm, Shoulder and Hand (DASH)Ultrasonography imaging of the contralateral shoulder
Contralateral shoulderThe Constant-Murley score (CMS)Ultrasonography imaging of the contralateral shoulder
Atraumatic rotator cuff tendon repairAmerican Shoulder and Elbow Surgeons (ASES) ScoreUltrasonography imaging of the operated shoulder
Atraumatic rotator cuff tendon repairThe Constant-Murley score (CMS)Ultrasonography imaging of the operated shoulder
Contralateral shoulderUltrasonography imagingUltrasonography imaging of the contralateral shoulder
Contralateral shoulderAmerican Shoulder and Elbow Surgeons (ASES) ScoreUltrasonography imaging of the contralateral shoulder
Primary Outcome Measures
NameTimeMethod
Ultrasonography5 years after primary repair

Integrity of the rotator cuff tendons

Secondary Outcome Measures
NameTimeMethod
American Shoulder and Elbow Surgeons (ASES) score5 years after primary repair

The higher the score, the better the outcome.

The Disabilities of the Arm, Shoulder and Hand (DASH)5 years after primary repair

The higher the score, more severe disability.

Constant-Murley score (CMS)5 years after primary repair

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

Trial Locations

Locations (1)

Tartu University Hospital

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Tartu, Tartumaa, Estonia

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