Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06394609 |
Other study ID # |
N-472-2018 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.