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

NCT07327437 | Completed DMC

• 1 other identifier: IRB: 11625-442021
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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."

Conditions

Rotator Cuff Tear

Keywords

Rotator cuff; Transosseous; Giant needle; Grand Knot

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Grand-Knot Group

EXPERIMENTAL

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

Procedure: Grand-Knot Technique

Suture Anchor Group

ACTIVE COMPARATOR

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

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

Interventions

All-Suture Anchors (Y-Knot RC) DEVICE

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

Suture Anchor Group

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).

Grand-Knot Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sherif Hamdy Zawam: lead

Study Sites (1)

Cairo University Hospitals (Kasr Al-Ainy)

Cairo, Egypt

Location

Related Publications (4)

• 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.

  PMID: 17321161 BACKGROUND

• 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.

  PMID: 22958838 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.

  BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Sherif Zawam, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Orthopedic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: January 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: July 1, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-12

Locations

EG (1)