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Arthroscopic Rotator Interval Closure in Shoulder Instability Repair

NCT00901797 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-02-11

No results posted yet for this 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.

Conditions

  • Recurrent Shoulder Dislocations

Interventions

PROCEDURE

Arthroscopic 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.

PROCEDURE

ABR+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 & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-05-31
Completion
2011-05-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00901797 on ClinicalTrials.gov