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

Sherif Hamdy Zawam

Status: Completed

Conditions: Rotator Cuff Tear

Treatments: Device: All-Suture Anchors (Y-Knot RC); Procedure: Grand-Knot Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07327437

IRB: 11625-442021

Details and patient eligibility

About

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."

Full 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."

Enrollment: 160 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Grand-Knot Group

Experimental group

Description:

Patients undergoing arthroscopic trans-osseous rotator cuff repair using the Grand-Knot suture-block technique.

Treatment:

Procedure: Grand-Knot Technique

Suture Anchor Group

Active Comparator group

Description:

Patients undergoing standard arthroscopic rotator cuff repair using all-suture anchors.

Treatment:

Device: All-Suture Anchors (Y-Knot RC)