Completed

NCT Number: NCT07327437

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."

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals (Kasr Al-Ainy)

Cairo, Egypt

About this study

"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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

All-Suture Anchors (Y-Knot RC)

Device

Standard repair using 2.8 mm all-suture anchors placed in the humeral footprint.

Primary outcomes

American Shoulder and Elbow Surgeons ASES Score

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sherif Hamdy Zawam

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2025
First posted: Jan 8, 2026
Registry last updated: Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed