Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT07004218
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-04
First Post:
2025-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative USG Control and Clinical Follow-up of Massive Rotator Cuff Tendon Ruptures
Sponsor:
Gazi University
Organization:
Study Overview
Official Title:
Postoperative USG Control and Clinical Follow-up of Massive Rotator Cuff Tendon Ruptures
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: