Rotator Cuff Tear
Conditions
Keywords
Rotator cuff, Transosseous, Giant needle, Grand Knot
Brief summary
The purpose of this study is to compare a novel, cost-effective arthroscopic trans-osseous rotator cuff repair technique, known as the 'Grand-Knot' technique, against the standard repair using all-suture anchors. The study evaluates which method provides better functional recovery and structural healing for patients with full-thickness supraspinatus tears. Patients were randomized to receive either the Grand-Knot repair or the standard anchor repair and were followed for a minimum of 2.5 years to assess shoulder function using the ASES score, range of motion, and tendon integrity.
Detailed description
This prospective randomized comparative study was designed to evaluate the clinical and biomechanical effectiveness of an anchorless trans-osseous repair for rotator cuff tears. Participants: 160 patients (aged 45-75) with full-thickness supraspinatus or posterosuperior tears were enrolled. Interventions: \> 1. Experimental Group: The Grand-Knot technique utilized a 'Giant Needle' to create trans-osseous tunnels, through which sutures were passed and secured using a specialized suture-block (Grand-Knot) on the lateral cortex. 2. Control Group: Standard arthroscopic repair was performed using 2.8 mm all-suture anchors (Y-Knot RC). Procedure: All surgeries were performed arthroscopically by a single senior surgeon. Postoperative rehabilitation was standardized for both groups. Outcomes: The primary endpoint was the American Shoulder and Elbow Surgeons (ASES) score at 30 months. Secondary endpoints included the Constant score, objective range of motion (ROM) measured by a goniometer, and structural integrity of the tendon as assessed by postoperative MRI or ultrasound at 6 months. Additionally, the study incorporates biomechanical data comparing the load-to-failure strength of both constructs.
Interventions
PROCEDUREGrand-Knot Technique
Use of a Giant-needle to create trans-osseous tunnels and securing the tendon with a specialized suture-block (Grand-Knot).
DEVICEAll-Suture Anchors (Y-Knot RC)
Standard repair using 2.8 mm all-suture anchors placed in the humeral footprint.
Sponsors
Sherif Hamdy Zawam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This is a prospective, two-arm, parallel-group randomized comparative study. Participants were allocated to either the Experimental Group (arthroscopic trans-osseous repair using the 'Grand-Knot' suture-block technique) or the Active Comparator Group (arthroscopic repair using all-suture anchors) in a 1:1 ratio. Randomization was achieved via a computer-generated sequence. Allocation concealment was maintained using sequentially numbered, sealed opaque envelopes opened by an independent assistant only after the intraoperative confirmation of tear morphology. Both groups followed an identical, standardized postoperative rehabilitation protocol and were assessed at predetermined intervals up to 30 months.
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 45 to 75 years. Diagnosis of full-thickness supraspinatus or posterosuperior rotator-cuff tears. Tears suitable for arthroscopic repair. Confirmation of diagnosis and tear morphology via standardized clinical examination and MRI. Willingness to comply with a 2.5-year follow-up protocol and standardized rehabilitation.
Exclusion criteria
* Partial-thickness tears or isolated subscapularis tears. Advanced fatty infiltration (Fuchs grade 3-4). Rotator cuff arthropathy (Hamada classification \> 2). Presence of calcific tendinitis in the affected shoulder. Prior ipsilateral shoulder surgery. General medical contraindications to arthroscopy or general anesthesia. Inability to complete the follow-up or provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons ASES Score | 30 months (2.5 years) postoperatively | The ASES score is a standardized clinician-completed and patient-reported instrument consisting of two sections: pain (50%) and activities of daily living (50%). The total score ranges from 0 to 100, where 100 indicates the best possible shoulder function and 0 indicates the worst. |
Countries
Egypt
Outcome results
None listed