Arthroscopic Trans-osseous Rotator-Cuff Repair Using the Giant-Needle and Grand-Knot Technique.

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."

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Procedure: Grand-Knot Technique; Device: All-Suture Anchors (Y-Knot RC)

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."

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University Hospitals (Kasr Al-Ainy)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Grand-Knot Group; Patients undergoing arthroscopic trans-osseous rotator cuff repair using the Grand-Knot suture-block technique.	Procedure: Grand-Knot Technique; Use of a Giant-needle to create trans-osseous tunnels and securing the tendon with a specialized suture-block (Grand-Knot).
Active Comparator: Suture Anchor Group; Patients undergoing standard arthroscopic rotator cuff repair using all-suture anchors.	Device: All-Suture Anchors (Y-Knot RC); Standard repair using 2.8 mm all-suture anchors placed in the humeral footprint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sherif Hamdy Zawam
• Investigators: Principal Investigator: Sherif Zawam, MD, Cairo University

Publications and helpful links

General Publications

• 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.
• 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.
• Dines JS, et al. Biomechanical comparison of all-suture anchors and traditional rigid anchors. Arthroscopy. 2016.
• Author et al. Arthroscopic trans-osseous rotator cuff repair using the Grand-Knot technique: A technical note. Journal Name. Year.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Rotator cuff; Transosseous; Giant needle; Grand Knot
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: IRB: 11625-442021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No