Arthroscopic Rotator Interval Closure in Shoulder Instability Repair

NCT00901797 | Unknown

• 1 other identifier: Dr. Maman
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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. 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. 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

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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 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.

• 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.

• 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.

Study Arms (2)

Arthroscopic Bankart repair

ACTIVE COMPARATOR

Procedure: Arthroscopic Bankart repair

ABR+ARIC

ACTIVE COMPARATOR

Procedure: ABR+ARIC

Interventions

Arthroscopic Bankart repair PROCEDURE

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.

Arthroscopic Bankart repair

ABR+ARIC PROCEDURE

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.

ABR+ARIC

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (2)

Shoulder Unit, Orthopedics B Department, Tel Aviv medical center

Tel Aviv, Israel

RECRUITING

TelAviv Suraski Medical Center

Tel Aviv, Israel

RECRUITING

Related Publications (2)

• 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.

  PMID: 14984192 BACKGROUND

• 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.

  PMID: 17560472 BACKGROUND

MeSH Terms

Conditions

Shoulder Dislocation; Bankart Lesions

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries; Shoulder Fractures; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 14, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2011
• Last Updated: February 11, 2010

Record last verified: 2009-05

Locations

IL (2)