Early Retears and Clinical Outcomes Following Surgical Repair of Massive Rotator Cuff TearsNCT07004218
Postoperative USG Control and Clinical Follow-up of Massive Rotator Cuff Tendon Ruptures
An observational study of Early Retears and Clinical Outcomes Following Surgical Repair of Massive Rotator Cuff Tears, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to investigate the tendon integrity and clinical outcomes following surgical repair of massive rotator cuff tears. Patients with preoperatively diagnosed massive tears, confirmed by MRI and scheduled for surgery, will be included. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Retears and Clinical Outcomes Following Surgical Repair of Massive Rotator Cuff Tears
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 30 Jul 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adult patients diagnosed with massive rotator cuff tears who are scheduled to undergo surgical repair at the Department of Orthopaedics and Traumatology, Gazi University Hospital. Eligible participants will be between 18 and 80 years of age and will have radiologically confirmed full-thickness rotator cuff tears involving at least two tendons and/or exhibiting tendon retraction to the glenoid level, as identified on preoperative MRI. All patients included in the study must be surgical candidates with no prior shoulder operations and must be able to comply with the follow-up schedule and postoperative rehabilitation protocol. The population will be prospectively followed for a minimum of 12 months, with serial clinical and ultrasonographic assessments performed at predefined intervals (2 weeks, 3 months, 6 months, and 12 months postoperatively). Data collected will include demographic characteristics, clinical scores (ASES, UCLA, VAS), and tendon in
Who may be able to join
- Diagnosis of a massive rotator cuff tear confirmed by preoperative magnetic resonance imaging (MRI), involving at least two tendons and/or retraction to the glenoid level.
- Scheduled for surgical rotator cuff repair at Gazi University Hospital, Department of Orthopaedics and Traumatology.
- Ability and willingness to undergo postoperative follow-up and imaging (ultrasound) at 2 weeks, 3 months, 6 months, and 12 months post-surgery.
- Ability to provide written informed consent.
- No prior surgery on the affected shoulder.
- Adequate cognitive and physical capacity to comply with postoperative rehabilitation protocols and outcome assessments.
Who cannot join
- Previous surgical intervention on the affected shoulder (including rotator cuff repair, shoulder arthroplasty, or arthroscopy).
- Irreparable rotator cuff tears determined intraoperatively (e.g., excessive retraction, poor tissue quality).
- Presence of advanced glenohumeral osteoarthritis (e.g., Hamada grade ≥ 3).
- Neurological disorders affecting shoulder function (e.g., brachial plexopathy, stroke-related hemiparesis).
- Systemic inflammatory or rheumatologic diseases (e.g., rheumatoid arthritis, lupus) affecting musculoskeletal function.
- Infectious conditions of the shoulder or systemic infection at the time of surgery.
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- Inability to attend regular follow-ups or comply with the rehabilitation protocol due to psychiatric illness, cognitive impairment, or other medical conditions.
- Refusal or inability to provide informed consent.
- Poor general health status contraindicating surgery or anesthesia (e.g., ASA IV or higher
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gazı University
Çankaya, Ankara, 0(541) 979 19 68
About this study
This prospective observational study aims to investigate the tendon integrity and clinical outcomes following surgical repair of massive rotator cuff tears. Patients with preoperatively diagnosed massive tears, confirmed by MRI and scheduled for surgery, will be included. Tendon healing will be assessed using ultrasonography at postoperative 2 weeks, 3 months, 6 months, and 12 months. Clinical evaluation will be conducted using standardized scoring systems including ASES, UCLA Shoulder Score, VAS, and thresholds for MCID, SCB, and PASS.
The primary outcome is the rate and timing of retears at 12 months and their correlation with functional recovery. The study also aims to identify prognostic factors affecting tendon survivability, such as age, tear size, and muscle quality. By combining imaging and clinical parameters, this study seeks to contribute to the optimization of postoperative follow-up and rehabilitation strategies in the treatment of massive rotator cuff tears.
Read the detailed description
This prospective observational study is designed to evaluate tendon healing and functional outcomes following surgical repair of massive rotator cuff tears. The study will be conducted at the Department of Orthopaedics and Traumatology, Gazi University Hospital. Patients aged between 18 and 80 years, diagnosed with massive rotator cuff tears on preoperative MRI and scheduled for surgical intervention, will be included.
Massive tears are defined as full-thickness tears involving two or more rotator cuff tendons and/or showing retraction to the level of the glenoid. Exclusion criteria include irreparable tears, prior shoulder surgery on the affected side, severe glenohumeral arthritis, neurological deficits affecting shoulder function, systemic inflammatory diseases, and inability to comply with follow-up.
Ultrasonographic evaluations of tendon integrity will be performed postoperatively at 2 weeks, 3 months, 6 months, and 12 months. These will be conducted by a radiologist in collaboration with orthopedic residents. Tendon status will be categorized as intact, partial retear, or complete retear. Clinical outcomes will be measured using the American Shoulder and Elbow Surgeons (ASES) Score, the UCLA Shoulder Score, the Visual Analog Scale (VAS), and evaluated in terms of Minimal Clinically Important Difference (MCID), Substantial Clinical Benefit (SCB), and Patient Acceptable Symptom State (PASS).
The primary endpoint is the rate of retear at 12 months and its association with clinical recovery. This study aims to clarify the relationship between early tendon healing and long-term functional outcomes, potentially guiding future management strategies in massive rotator cuff repair.
- Conditions
- Early Retears and Clinical Outcomes Following Surgical Repair of Massive Rotator Cuff Tears
- Keywords
- Massive rotator cuff tear, Rotator cuff repair, Retear, Postoperative follow-up, Tendon survivability
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is tendon integrity at 12 months postoperatively, evaluated by ultrasonography, and its correlation with clinical outcomes including ASES, UCLA, VAS scores, and MCID. Retear presence and timing will also be recorded.
This prospective observational study aims to evaluate early tendon healing and clinical outcomes following surgical repair of massive rotator cuff tears. Patients diagnosed preoperatively with massive rotator cuff tears via MRI and scheduled for surgery at Gazi University Hospital will be included. Tendon integrity will be assessed through ultrasonography at 2 weeks, 3 months, 6 months, and 12 months postoperatively. Clinical outcomes will be measured using ASES, UCLA Shoulder Score, and VAS, as well as MCID, SCB, and PASS thresholds. The correlation between anatomical healing and functional recovery will be investigated. Patients aged 18-80 years without prior shoulder surgery will be eligible. Exclusion criteria include irreparable tears, neurological disorders, and systemic inflammatory diseases. The primary endpoint is retear rate at 12 months. Data will be collected by orthopedic surgeons and radiologists. This study aims to identify prognostic indicators for tendon survivability
Measured: Ultrasonography and clinical evaluations will be conducted at 2 weeks, 3 months, 6 months, and 12 months postoperatively to assess tendon integrity and functional outcomes following rotator cuff repair.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Feb 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Retears and Clinical Outcomes Following Surgical Repair of Massive Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan ARAL, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004218
- Sponsor's protocol ID
- E-77082166-604.01-1134735
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative USG Control and Clinical Follow-up of Massive Rotator Cuff Tendon Ruptures
- ClinicalTrials.gov ID
- NCT07004218
- Acronym / sponsor ID
- E-77082166-604.01-1134735
- Conditions
- Early Retears and Clinical Outcomes Following Surgical Repair of Massive Rotator Cuff Tears
- Keywords
- Massive rotator cuff tear, Rotator cuff repair, Retear, Postoperative follow-up, Tendon survivability
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study aims to investigate the tendon integrity and clinical outcomes following surgical repair of massive rotator cuff tears. Patients with preoperatively diagnosed massive tears, confirmed by MRI and scheduled for surgery, will be included. Tendon healing will be assessed using ultrasonography at postoperative 2 weeks, 3 months, 6 months, and 12 months. Clinical evaluation will be conducted using standardized scoring systems including ASES, UCLA Shoulder Score, VAS, and thresholds for MCID, SCB, and PASS.
The primary outcome is the rate and timing of retears at 12 months and their correlation with functional recovery. The study also aims to identify prognostic factors affecting tendon survivability, such as age, tear size, and muscle quality. By combining imaging and clinical parameters, this study seeks to contribute to the optimization of postoperative follow-up and rehabilitation strategies in the treatment of massive rotator cuff tears.
Detailed description
This prospective observational study is designed to evaluate tendon healing and functional outcomes following surgical repair of massive rotator cuff tears. The study will be conducted at the Department of Orthopaedics and Traumatology, Gazi University Hospital. Patients aged between 18 and 80 years, diagnosed with massive rotator cuff tears on preoperative MRI and scheduled for surgical intervention, will be included.
Massive tears are defined as full-thickness tears involving two or more rotator cuff tendons and/or showing retraction to the level of the glenoid. Exclusion criteria include irreparable tears, prior shoulder surgery on the affected side, severe glenohumeral arthritis, neurological deficits affecting shoulder function, systemic inflammatory diseases, and inability to comply with follow-up.
Ultrasonographic evaluations of tendon integrity will be performed postoperatively at 2 weeks, 3 months, 6 months, and 12 months. These will be conducted by a radiologist in collaboration with orthopedic residents. Tendon status will be categorized as intact, partial retear, or complete retear. Clinical outcomes will be measured using the American Shoulder and Elbow Surgeons (ASES) Score, the UCLA Shoulder Score, the Visual Analog Scale (VAS), and evaluated in terms of Minimal Clinically Important Difference (MCID), Substantial Clinical Benefit (SCB), and Patient Acceptable Symptom State (PASS).
The primary endpoint is the rate of retear at 12 months and its association with clinical recovery. This study aims to clarify the relationship between early tendon healing and long-term functional outcomes, potentially guiding future management strategies in massive rotator cuff repair.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients diagnosed with massive rotator cuff tears who are scheduled to undergo surgical repair at the Department of Orthopaedics and Traumatology, Gazi University Hospital. Eligible participants will be between 18 and 80 years of age and will have radiologically confirmed full-thickness rotator cuff tears involving at least two tendons and/or exhibiting tendon retraction to the glenoid level, as identified on preoperative MRI. All patients included in the study must be surgical candidates with no prior shoulder operations and must be able to comply with the follow-up schedule and postoperative rehabilitation protocol. The population will be prospectively followed for a minimum of 12 months, with serial clinical and ultrasonographic assessments performed at predefined intervals (2 weeks, 3 months, 6 months, and 12 months postoperatively). Data collected will include demographic characteristics, clinical scores (ASES, UCLA, VAS), and tendon in
Key inclusion criteria (6 listed)
- Diagnosis of a massive rotator cuff tear confirmed by preoperative magnetic resonance imaging (MRI), involving at least two tendons and/or retraction to the glenoid level.
- Scheduled for surgical rotator cuff repair at Gazi University Hospital, Department of Orthopaedics and Traumatology.
- Ability and willingness to undergo postoperative follow-up and imaging (ultrasound) at 2 weeks, 3 months, 6 months, and 12 months post-surgery.
- Ability to provide written informed consent.
- No prior surgery on the affected shoulder.
Key exclusion criteria (9 listed)
- Previous surgical intervention on the affected shoulder (including rotator cuff repair, shoulder arthroplasty, or arthroscopy).
- Irreparable rotator cuff tears determined intraoperatively (e.g., excessive retraction, poor tissue quality).
- Presence of advanced glenohumeral osteoarthritis (e.g., Hamada grade ≥ 3).
- Neurological disorders affecting shoulder function (e.g., brachial plexopathy, stroke-related hemiparesis).
- Systemic inflammatory or rheumatologic diseases (e.g., rheumatoid arthritis, lupus) affecting musculoskeletal function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary outcome is tendon integrity at 12 months postoperatively, evaluated by ultrasonography, and its correlation with clinical outcomes including ASES, UCLA, VAS scores, and MCID. Retear presence and timing will also be recorded.
Time frame: Ultrasonography and clinical evaluations will be conducted at 2 weeks, 3 months, 6 months, and 12 months postoperatively to assess tendon integrity and functional outcomes following rotator cuff repair.
This prospective observational study aims to evaluate early tendon healing and clinical outcomes following surgical repair of massive rotator cuff tears. Patients diagnosed preoperatively with massive rotator cuff tears via MRI and scheduled for surgery at Gazi University Hospital will be included. Tendon integrity will be assessed through ultrasonography at 2 weeks, 3 months, 6 months, and 12 months postoperatively. Clinical outcomes will be measured using ASES, UCLA Shoulder Score, and VAS, as well as MCID, SCB, and PASS thresholds. The correlation between anatomical healing and functional recovery will be investigated. Patients aged 18-80 years without prior shoulder surgery will be eligible. Exclusion criteria include irreparable tears, neurological disorders, and systemic inflammatory diseases. The primary endpoint is retear rate at 12 months. Data will be collected by orthopedic surgeons and radiologists. This study aims to identify prognostic indicators for tendon survivability
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Retears and Clinical Outcomes Following Surgical Repair of Massive Rotator Cuff Tears, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome is tendon integrity at 12 months postoperatively, evaluated by ultrasonography, and its correlation with clinical outcomes including ASES, UCLA, VAS scores, and MCID. Retear presence and timing will also be recorded. (time frame: Ultrasonography and clinical evaluations will be conducted at 2 weeks, 3 months, 6 months, and 12 months postoperatively to assess tendon integrity and functional outcomes following rotator cuff repair.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.