- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06394609
Comparison of Arthroscopic Bankart Repair Using Double Loaded Grand Knot Technique Versus Double Loaded Knotted Suture Anchor
Arthroscopic Bankart Repair Using Double Loaded Grand Knot Technique Versus Double Loaded Knotted Suture Anchor; Comparative Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt
- Faculty of medicine, Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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:
- Significant bony pathology (bony bankart)
- Poor quality capsule-labral tissue
- Multi directional instability
- Ligamentous laxity
- ALPSA lesion
- Hillsachs lesion more than 10 %
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- N-472-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Arthroscopic Bankart Repair
-
Sheba Medical CenterUnknownShoulder Proprioception | Open Capsular Shift | Arthroscopic Bankart Repair | Unrestricted Arm MovementIsrael
-
Keck School of Medicine of USCNot yet recruiting
-
Cairo UniversityCompletedArthroscopic Shoulder Surgery | Arthroscopic Bankart Repair | Hand Grip Strength | Rotator Cuff StrengthEgypt
-
Chinese University of Hong KongNot yet recruiting
-
Zagazig UniversityRecruitingArthroscopic Rotator Cuff RepairEgypt
-
Queen Savang Vadhana Memorial Hospital, ThailandCompletedArthroscopic Rotator Cuff RepairThailand
-
Children's Hospital of PhiladelphiaChildren's Anesthesiology Associates, Ltd.TerminatedMeniscectomy | ACL Repair | Bankart RepairUnited States
-
Samsung Medical CenterUnknownSubscapularis Tendon Tear | Arthroscopic Repair | Arthroscopic DebridementKorea, Republic of
-
University Hospital, Basel, SwitzerlandDePuy SynthesRecruitingArthroscopic Rotator Cuff Repair (ARCR)Switzerland
-
University of LiegeUnknownSurgery of Arthroscopic Anterior Cruciate Ligament RepairBelgium
Clinical Trials on double loaded knotted suture anchor
-
ConMed Linvatec BeijingCompleted
-
The Hawkins FoundationCompleted
-
Smith & Nephew Orthopaedics AGCompletedInstability, JointSpain, Italy, United States, Denmark, Finland, United Kingdom
-
Matt SmithCompletedRotator Cuff TearsUnited States
-
Kaiser PermanenteUniversity of California, San DiegoUnknown
-
Chinese University of Hong KongNot yet recruiting
-
Zimmer BiometTerminatedShoulder Injuries | Shoulder Pain | Labral Tear, Glenoid | Shoulder Disease | Shoulder Syndrome | Shoulder Pain ChronicUnited States
-
Smith & Nephew, Inc.CompletedAcetabular Labrum Tear | SLAP Lesion | Bankart Lesions | Rotator Cuff Tears | Labral Tear, Glenoid | Anterior Shoulder InstabilityUnited States
-
Spine Care, OklahomaCompletedSpinal Cord StimulationUnited States
-
Al-Azhar UniversityCompletedPosterior Root Tear of the Medial Meniscus | Arthroscopic Transtibial Pullout Suture Repair | Suture Anchor RepairEgypt