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Study Type: Prospective, three-arm parallel randomized controlled trial (RCT) Study Objective: To compare the 12-month/5 years/10years functional outcomes, morphological healing, cost-effectiveness, and complication rates of three treatment strategies for displaced greater tuberosity (GT) fractures with rotator cuff injury, and to optimize the individualized treatment strategy for GT fractures.
Study Setting: multicenter clinical trial, conducted in the Department of Orthopedics.
Study Period: April 2026 -April 2036.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative Treatment Group (CG) | No Intervention | no operation | |
| Primary Surgery Group (PG) | Experimental | operation immediately |
|
| Delayed Surgery Group (DG) | Experimental | operation after 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic surgery | Procedure | Conservative Treatment Group (CG): rehabilitation only ; Primary Surgery Group (PG): surgery early; Delayed Surgery Group (DG): surgery late |
|
| Measure | Description | Time Frame |
|---|---|---|
| SPADI (Shoulder Pain and Disability Index) score at 12 months, to compare the functional recovery differences among the three arms. | Time Frame: Baseline, 3 months, 6 months, and 12 months, 60 month, 120 months |
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Inclusion Criteria:
• Age 18-76 years, male or female;
Exclusion Criteria:
• Pathological fracture or old fracture (>3 weeks);
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| ID | Term |
|---|---|
| D001182 | Arthroscopy |
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019637 | Orthopedic Procedures |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |