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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-07-01

Brief Summary

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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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Detailed Description

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"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

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Rotator Cuff Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Grand-Knot Group

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

Group Type EXPERIMENTAL

Grand-Knot Technique

Intervention Type PROCEDURE

Use of a Giant-needle to create trans-osseous tunnels and securing the tendon with a specialized suture-block (Grand-Knot).

Suture Anchor Group

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

Group Type ACTIVE_COMPARATOR

All-Suture Anchors (Y-Knot RC)

Intervention Type DEVICE

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

Interventions

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Grand-Knot Technique

Use of a Giant-needle to create trans-osseous tunnels and securing the tendon with a specialized suture-block (Grand-Knot).

Intervention Type PROCEDURE

All-Suture Anchors (Y-Knot RC)

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No