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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."
"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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grand-Knot Group | Experimental | Patients undergoing arthroscopic trans-osseous rotator cuff repair using the Grand-Knot suture-block technique. |
|
| Suture Anchor Group | Active Comparator | Patients undergoing standard arthroscopic rotator cuff repair using all-suture anchors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grand-Knot Technique | Procedure | Use of a Giant-needle to create trans-osseous tunnels and securing the tendon with a specialized suture-block (Grand-Knot). |
|
| Measure | Description | Time Frame |
|---|---|---|
| American Shoulder and Elbow Surgeons ASES Score | 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. | 30 months (2.5 years) postoperatively |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Sherif Zawam, MD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals (Kasr Al-Ainy) | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17321161 | Background | Park MC, ElAttrache NS, Tibone JE, Ahmad CS, Jun BJ, Lee TQ. Part I: Footprint contact characteristics for a transosseous-equivalent rotator cuff repair technique compared with a double-row repair technique. J Shoulder Elbow Surg. 2007 Jul-Aug;16(4):461-8. doi: 10.1016/j.jse.2006.09.010. Epub 2007 Feb 22. | |
| 22958838 | Background |
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The decision to share individual participant data has not yet been finalized. Access to de-identified data may be considered upon reasonable request to the Principal Investigator, subject to approval by the Cairo University Faculty of Medicine Research Ethics Committee and in accordance with institutional data privacy policies.
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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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.
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| All-Suture Anchors (Y-Knot RC) | Device | Standard repair using 2.8 mm all-suture anchors placed in the humeral footprint. |
|
| Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13. |
| Background | Dines JS, et al. Biomechanical comparison of all-suture anchors and traditional rigid anchors. Arthroscopy. 2016. |
| Background | Author et al. Arthroscopic trans-osseous rotator cuff repair using the Grand-Knot technique: A technical note. Journal Name. Year. |