Comparison of Arthroscopic Bankart Repair Using Double Loaded Grand Knot Technique Versus Double Loaded Knotted Suture Anchor

April 28, 2024 updated by: Mahmoud Ahmed El-Desouky, Cairo University

Arthroscopic Bankart Repair Using Double Loaded Grand Knot Technique Versus Double Loaded Knotted Suture Anchor; Comparative Study

Arthroscopic surgery is the preferred method to fix a Bankart lesion (tears in the labrum) and has better patient outcomes. It's important to assess any bone loss in the shoulder socket before surgery for a successful outcome. Using suture anchors to reattach the torn tissue is advantageous because it avoids going through the back of the shoulder. The article describes a specific technique for tying the sutures and anchor placement to minimize nerve and artery damage. Design of the suture anchor and how the suture is placed can affect its strength. Using two sutures per anchor (double-loaded) might be just as strong as using three anchors with one suture each (single-loaded), which is more common. This could save cost and bone but needs further study. The study proposes a new surgical technique using double-loaded anchors with more sutures to see if it offers similar strength while reducing implant use.

Study Overview

Detailed Description

Anatomical repair of the capsulolabral complex of the glenoid has become the gold- standard treatment for traumatic anterior shoulder instability associated with Bankart lesion.Arthroscopic technique results was better in postoperative functional outcome. (1) Specific findings in the history and the physical examination provide important clues to the presence of glenoid bone loss, and a careful preoperative evaluation to diagnose and quantify anterior glenoid deficiency is crucial for the success of surgical treatment. (2)

The use of suture anchors technique has the advantage of allowing the capsuloligamentous structures to be shifted superiorly and properly tensioned without the need to penetrate posteriorly. (3)

The grand knot is a double loop with an alternative half hitches 5 clock and 5 anticlockwise with total 30 hitches (big enough to hang on bony tunnel made by the guide wire). The anchors hanged over the posterior glenoid by pull out technique using number 2 proline introduced by the guide wire through the anterior portal. Skin exit will be 2 cm lateral and 5 cm inferior to postero-lateral corner of the acromion (safe zone) by which, the low postero-lateral portal will be 1.5 cm away from axillary nerve and 1.4 cm away from the posterior humeral circumflex artery to avoid any neurovascular injury. (4) Simple attention to potential variations in the origin and course of the axillary nerve and its relationship to the shoulder capsule and having a precise knowledge of ''safe zones'' during operations can enhance surgical outcomes. (5) Abrasion of the suture during intraoperative and postoperative cyclic loading may be an important cause of suture weakening and breakage. This situation may be made worse by angulation of the suture with respect to the anchor's axis (SA) and by the rotational orientation of the anchor's eyelet with respect to the plane of the suture (RA) (6) The use of double loaded suture anchors can provide biomechanical strength equivalent to that provided by the currently recommended and frequently used single-loaded 3- anchor constructs. The use of more suture anchors has negative implications for the biomechanical strength of the repair and compromises glenoid fixation and bone stock Using fewer anchors with more sutures per anchor may protect glenoid bone stock while achieving comparable biomechanical stability. (7) Arthroscopic double-loaded single-row repair using suture anchors containing two non- absorbable braided sutures in chronic anterior shoulder dislocation is reliable procedure with respect to recurrence rate, range of motion, and shoulder function. (8) The following study is aiming to assess the functional outcomes after arthroscopic bankart repair using double loaded grand knot technique that increase number of sutures which hypothetically provide better biomechanical strength in repairing capsule

-labral complex with reduced implants costs and compare it with using double loaded anchors in patients who will be followed up for 12 months.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Giza, Egypt
        • Faculty of medicine, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with recurrent anterior glenohumeral subluxation or dislocation after an initial episode of traumatic anterior shoulder dislocation, a Bankart lesion confirmed by arthroscopic examination and Magnetic resonance imaging (MRI)

Exclusion Criteria:

  1. Significant bony pathology (bony bankart)
  2. Poor quality capsule-labral tissue
  3. Multi directional instability
  4. Ligamentous laxity
  5. ALPSA lesion
  6. Hillsachs lesion more than 10 %

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: double loaded knotted suture anchor
arthroscopic bankart repair by using double loaded knotted suture anchor
arthroscopic bankart repair by using double loaded knotted suture anchor
arthroscopic bankart repair by using double grand knot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Constant score
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
ASES Shoulder Score
Time Frame: 12 months
12 months
Rowe score
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

April 28, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2024

Last Update Submitted That Met QC Criteria

April 28, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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