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Arthroscopic Rotator Interval Closure in Shoulder Instability Repair

N/AUnknownNCT00901797
Tel-Aviv Sourasky Medical Center100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Recurrent Shoulder Dislocations

Interventions

Arthroscopic Bankart repairPROCEDURE

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.

ABR+ARICPROCEDURE

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.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 40 Years
Medical Language ↔ Plain English
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

Locations (2)

Shoulder Unit, Orthopedics B Department, Tel Aviv medical center

Tel Aviv, Israel

RECRUITING

TelAviv Suraski Medical Center

Tel Aviv, Israel

RECRUITING

Outcomes

Primary Outcomes

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

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.

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.

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.

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.

Data from ClinicalTrials.gov

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