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Status unknownNCT00901797Updated Feb 11, 2010

Arthroscopic Rotator Interval Closure in Shoulder Instability Repair

An interventional study of Arthroscopic Bankart repair and ABR+ARIC in Recurrent Shoulder Dislocations, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 2 sites in Israel. Open to participants aged 16 Years to 40 Years. Per ClinicalTrials.gov, last updated 2010-02-11.

Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
16 Years to 40 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Recurrent Shoulder Dislocations

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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
03

In context

Shoulder Dislocation

103 studies on the registry are indexed under Shoulder Dislocation; 23 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 70 interventional studies indexed under Shoulder Dislocation.

Browse Shoulder Dislocation studies →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Previous humerus/glenoid fracture
  • large bony "Bankart"
  • Previous shoulder operation
  • Adhesive capsulitis-Habitual dislocations
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Arthroscopic Bankart repair

    Procedure: Arthroscopic Bankart repair

  • Active comparator
    ABR+ARIC

    Procedure: ABR+ARIC

Interventions

  • ProcedureArthroscopic Bankart repair

    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.

06

What researchers measure

Primary outcomes

  1. Recurrent shoulder dislocation or instability symptoms

    Time frame: 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.

Secondary outcomes

  1. Post operative range of motion (ROM)

    Time frame: 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.

  2. Activity level

    Time frame: 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.

  3. Need for recurrent surgery

    Time frame: 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.

  4. Pain

    Time frame: 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.

07

Study locations

2 of 2 sites recruiting
  • Shoulder Unit, Orthopedics B Department, Tel Aviv medical center
    Tel Aviv, Israel
    Recruiting
  • TelAviv Suraski Medical Center
    Tel-Aviv, Israel
    Recruiting
08

References and documents

Publications

  • Stokes DA, Savoie FH 3rd, Field LD, Ramsey JR. Arthroscopic repair of anterior glenohumeral instability and rotator interval lesions. Orthop Clin North Am. 2003 Oct;34(4):529-38. doi: 10.1016/s0030-5898(03)00091-9. PubMed 14984192 ↗
  • Provencher MT, Mologne TS, Hongo M, Zhao K, Tasto JP, An KN. Arthroscopic versus open rotator interval closure: biomechanical evaluation of stability and motion. Arthroscopy. 2007 Jun;23(6):583-92. doi: 10.1016/j.arthro.2007.01.010. PubMed 17560472 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00901797
Lead sponsor
Tel-Aviv Sourasky Medical Center
First posted
May 14, 2009
Start date
May 2009
Primary completion
May 2010 (estimated)
Completion
May 2011 (estimated)
Last update
Feb 11, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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