Large to Massive Rotator Cuff Tears with Severe Degeneration
Conditions
Interventions
Control group:After arthroscopic debridement of the subacromial space, the torn rotator cuff tissue is fully exposed and carefully released. Two 4.5-mm bioabsorbable suture anchors (GRYPHON) are inser
Trial group:The width of the iliotibial band (ITB) graft is determined by arthroscopically measuring the anterior-to-posterior defect length of the supraspinatus and infraspinatus tendon tears. The le
if it is less than 3 mm, the longer graft is folded to achieve adequate thickness.
Markings are made at 2 cm and 4 cm from the proximal end of the graft. Sutures are attached to both ends of the graf
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and 3 cm); 3. Preoperative magnetic resonance imaging (MRI) must demonstrate poor rotator cuff quality (significant tendon degeneration and retraction); 4. Patients must be undergoing surgical intervention (patients will be offered a choice between two surgical approaches: simple suture repair [gold standard] or augmentation with iliotibial band graft to the supraspinatus); Note: Criteria for assessing rotator cuff degeneration and retraction (1) Three core MRI evaluation parameters preoperatively: 1) Muscle Degeneration: The area of fatty infiltration within the supraspinous fossa is >= 50% of the muscle area (marked fatty infiltration). 2) Tendon Degeneration: The tendon is significantly thinned with associated fatty degeneration, or the tendon tissue is completely absent (severe degeneration). 3) Tendon Retraction: The tendon has retracted to the medial half of the humeral head or to the glenoid (marked retraction). (2) Overall Determination Criteria: Patients must meet at least two out of the three above criteria.
Exclusion criteria
Exclusion criteria: 1. Absolute anesthesia contraindications (ASA class >= III); 2. Periscapular muscle atrophy or neurological injury; 3. Advanced glenohumeral arthritis (Hamada classification >= Grade 4): Grade 4: Acromiohumeral interval narrowing + glenohumeral osteoarthritis; Grade 5: Humeral head cartilage loss; 4. Active local or systemic infection; 5. Irreparable tear (confirmed by both): Severe tendon degeneration/retraction on preoperative MRI; Intraoperative arthroscopic assessment; 6. Poor glycemic control (per 2020 Expert Consensus on Perioperative Glucose Management): Fasting glucose > 7.8 mmol/L; Postprandial/random glucose > 10.0 mmol/L; 7. Non-compliance with standardized postoperative rehabilitation protocol; 8. History of previous surgery on the affected shoulder; 9. Coexisting conditions that severely affect shoulder muscle strength (e.g., cervical spondylosis, myasthenia gravis); 10. Subscapularis tendon tear; 11. Shoulder trauma interfering with muscle strength measurement; 12. Inability to provide informed consent due to intellectual impairment or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rotator cuff healing status at 12 months postoperatively (defined as good for Sugaya type II or higher, and poor otherwise).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lsokinetic Muscle Strength Testing;Time of surgery;Active range of motion of the shoulder, including forward flexion, abduction, external rotation at the side, and internal rotation.;ASES score;Postoperative Drainage Volume;Rotator cuff healing status at preoperatively and 6 months postoperatively (defined as good for Sugaya type II or higher, and poor otherwise).;Warner classification;Goutallier classification;Blood Loss;Hamada classification;Constant score;AHD classification;Visual Analog Scale (VAS) score;Complications / Adverse Events; | — |
Countries
China
Contacts
Public ContactZhou Binghua
The First Affiliated Hospital of Army Medical University
Outcome results
None listed