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

Arthroscopic Bankart Repair Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06394609
• Other study ID #: N-472-2018
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: April 30, 2023

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months and older

Eligibility

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 %

Related Conditions & MeSH terms

• Arthroscopic Bankart Repair

Intervention

Other:
• double loaded knotted suture anchor
arthroscopic bankart repair by using double loaded knotted suture anchor
• double grand knot
arthroscopic bankart repair by using double grand knot

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant score		12 months
Secondary	ASES Shoulder Score		12 months
Secondary	Rowe score		12 months