NCT07327437

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Sherif Hamdy Zawam · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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."

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
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).
DEVICE	All-Suture Anchors (Y-Knot RC)	Standard repair using 2.8 mm all-suture anchors placed in the humeral footprint.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-01-01
• Completion: 2025-07-01
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

1 site across 1 country: Egypt