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Arthroscopic Rotator Interval Closure in Shoulder Instability Repair

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00901797
Enrollment
100
Registered
2009-05-14
Start date
2009-05-31
Completion date
2011-05-31
Last updated
2010-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Shoulder Dislocations

Keywords

ABD, ABDuction, ABR, Arthroscopic Bankart Repair, ACJ, AcromioClavicular Joint, AD, Anterior Drawer, ARIC, Arthroscopic Rotator Interval Closure, BL, Bankart Lesion, CHL, CoracoHumeral Ligament, ER, External Rotation, FF, Forward Flexion, GHJ, GlenoHumeral Joint, HSL, HillSacs Lesion, IR, Internal Rotation, ISP, InfraSPinatus, PD, Posterior Drawer, RI, Rotator Interval, ROM, Range Of Motion, SGHL, Superior GlenoHumeral Ligament, SSC, SubSCapularis, SSP, SupraSPinatus

Brief summary

Study Title: Arthroscopic rotator interval closure in shoulder instability repair - a prospective study Objective: To evaluate the effect of arthroscopic rotator interval closure (ARIC) on patients with recurrent shoulder dislocations undergoing arthroscopic bankart repair (ABR) in terms of recurrence, rehabilitation and function. Hypothesis: 1. Although Hyperlax patients undergoing ABR have higher incidence of recurrent shoulder dislocations than those without hyperlaxity, adding ARIC will lower the recurrent dislocation rate. 2. Patients with arthroscopic bankart repair (ABR) and ARIC are slower in gaining the range of motion (ROM) but within 6 months are equal to those with ABR only.

Interventions

Seated in a beach chair position, arm fixed with a skin traction device (Spider shoulder Immobilizer or 3kg traction), arthroscopy through a posterior portal, anterior portal used for inspection and instrumentation, labral lesion released using a suture liberator, full radius and VAPER. Preparation of the glenoid with rasp up and down. Insertion of anchors as necessary into the glenoid and ligation of labral lesion with the sutures. Wound closure with ethilon 4/0 suture, striped dressing, velpeau arm sling.

PROCEDUREABR+ARIC

Seated in a beach chair position, arm fixed with a skin traction device (Spider shoulder Immobilizer or 3kg traction), arthroscopy through a posterior portal, anterior portal used for inspection and instrumentation, labral lesion released using a suture liberator, full radius and VAPER. Preparation of the glenoid with rasp up and down. Insertion of anchors as necessary into the glenoid and ligation of labral lesion with the sutures. Through additional anterior superior portal a suture is passed inferior and adjacent to the SSP and through the superior portion of the Sub Scapularis tendon while the arm in 30 degree of external rotation. Tightening the suture on top of the capsule underneath the deltoid. Wound closure with ethilon 4/0 suture, striped dressing, velpeau arm sling.

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Age 16-40 years old * Anterior Shoulder instability * Hyperlaxity (general and shoulder laxity)

Exclusion criteria

* Previous humerus/glenoid fracture * large bony Bankart * Previous shoulder operation * Adhesive capsulitis-Habitual dislocations

Design outcomes

Primary

MeasureTime frame
Recurrent shoulder dislocation or instability symptomsPatients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.

Secondary

MeasureTime frame
Post operative range of motion (ROM)Patients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.
Activity levelPatients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.
Need for recurrent surgeryPatients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.
PainPatients will be followed in hospital shoulder clinic 6, 12, 26, 52 weeks post op and then in 1 year intervals until final follow up.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026