NCT06394609

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

4.4 years

First QC Date

April 28, 2024

Last Update Submit

April 28, 2024

Conditions

Keywords

Arthroscopic Bankart Repairdouble loaded Grand Knot TechniqueDouble loaded knotted suture Anchortraumatic anterior shoulder instability

Outcome Measures

Primary Outcomes (1)

  • Constant score

    12 months

Secondary Outcomes (2)

  • ASES Shoulder Score

    12 months

  • Rowe score

    12 months

Study Arms (1)

double loaded knotted suture anchor

EXPERIMENTAL

arthroscopic bankart repair by using double loaded knotted suture anchor

Other: double loaded knotted suture anchorOther: double grand knot

Interventions

arthroscopic bankart repair by using double loaded knotted suture anchor

double loaded knotted suture anchor

arthroscopic bankart repair by using double grand knot

double loaded knotted suture anchor

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Significant bony pathology (bony bankart)
  • Poor quality capsule-labral tissue
  • Multi directional instability
  • Ligamentous laxity
  • ALPSA lesion
  • Hillsachs lesion more than 10 %

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University

Giza, Egypt

Location

Related Publications (1)

  • Rashwan AS, Amin AQ, Zawam SH, Soliman AM, El-Desouky M. Arthroscopic Bankart repair using trans-glenoid double-loaded grand knots versus double-loaded suture anchors; is there a difference? a randomized controlled study. BMC Musculoskelet Disord. 2025 Mar 21;26(1):280. doi: 10.1186/s12891-025-08477-3.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Patients with recurrent anterior glenohumeral subluxation or dislocation after an initial episode of traumatic anterior shoulder dislocation, a Bankart lesion confirmed by Magnetic resonance imaging (MRI) and arthroscopic examination. We would like to report the 12 months clinical outcomes of double loaded grand knot technique and knotted double loaded anchor used in traumatic anterior dislocations of the shoulder
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 28, 2024

First Posted

May 1, 2024

Study Start

December 1, 2018

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

May 1, 2024

Record last verified: 2024-04

Locations