Arthroscopic Rotator Interval Closure in Shoulder Instability Repair

Recurrent Shoulder Dislocations Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00901797
• Other study ID #: Dr. Maman
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2009
• Last updated: February 10, 2010
• Start date: May 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2009
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2011
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dislocations
• Recurrence
• Recurrent Shoulder Dislocations
• Shoulder Dislocation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Shoulder Unit, Orthopedics B Department, Tel Aviv medical center	Tel Aviv
Israel	TelAviv Suraski Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent shoulder dislocation or instability symptoms		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.	No
Secondary	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.	No
Secondary	Activity level		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.	No
Secondary	Need for recurrent surgery		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.	No
Secondary	Pain		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.	No