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Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Estonia
Study Type
Interventional
Intervention
Ultrasonography imaging
American Shoulder and Elbow Surgeons (ASES) Score
The Constant-Murley score (CMS)
The Disabilities of the Arm, Shoulder and Hand (DASH)
Sponsored by
Tartu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Rotator Cuff Tears focused on measuring rotator cuff injury, rotator cuff tears, sonography, shoulder injuries, atraumatic tears, shoulder pathology, shoulder ultrasound

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Tartu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Atraumatic rotator cuff tendon repair

Contralateral shoulder

Arm Description

Ultrasonography imaging of the operated shoulder

Ultrasonography imaging of the contralateral shoulder

Outcomes

Primary Outcome Measures

Ultrasonography
Integrity of the rotator cuff tendons

Secondary Outcome Measures

American Shoulder and Elbow Surgeons (ASES) score
The higher the score, the better the outcome.
Constant-Murley score (CMS)
The higher the score, the higher the quality of the function.
The Disabilities of the Arm, Shoulder and Hand (DASH)
The higher the score, more severe disability.

Full Information

First Posted
August 4, 2023
Last Updated
August 24, 2023
Sponsor
Tartu University Hospital
Collaborators
University of Tartu
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1. Study Identification

Unique Protocol Identification Number
NCT05988541
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tartu University Hospital
Collaborators
University of Tartu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atraumatic rotator cuff tendon repair
Arm Type
Other
Arm Description
Ultrasonography imaging of the operated shoulder
Arm Title
Contralateral shoulder
Arm Type
Other
Arm Description
Ultrasonography imaging of the contralateral shoulder
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasonography imaging
Intervention Description
Ultrasonography: rotator cuff tendons (supraspinatus, infraspinatus, subscapularis and teres minor) integrity, long head of the biceps tendon integrity and location, SASD (subacromial-subdeltoid) bursitis, synovitis and muscle atrophy.
Intervention Type
Diagnostic Test
Intervention Name(s)
American Shoulder and Elbow Surgeons (ASES) Score
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
The Constant-Murley score (CMS)
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
The Disabilities of the Arm, Shoulder and Hand (DASH)
Intervention Description
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 Outcome Measure Information:
Title
Ultrasonography
Description
Integrity of the rotator cuff tendons
Time Frame
5 years after primary repair
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons (ASES) score
Description
The higher the score, the better the outcome.
Time Frame
5 years after primary repair
Title
Constant-Murley score (CMS)
Description
The higher the score, the higher the quality of the function.
Time Frame
5 years after primary repair
Title
The Disabilities of the Arm, Shoulder and Hand (DASH)
Description
The higher the score, more severe disability.
Time Frame
5 years after primary repair

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tiina Tikk, MD
Phone
55929399
Ext
+372
Email
tiinatikk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Madis Rahu, PhD/MD
Email
madis.rahu@regionaalhaigla.ee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiina Tikk, MD
Organizational Affiliation
Tartu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tartu University Hospital
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50410
Country
Estonia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiina Tikk, MD
Phone
55929399
Ext
+372
Email
tiinatikk@gmail.com
First Name & Middle Initial & Last Name & Degree
Madis Rahu, PhD/MD
Email
madis.rahu@regionaalhaigla.ee

12. IPD Sharing Statement

Plan to Share IPD
No

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Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair.

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