Arthroscopic Rotator Interval Closure in Shoulder Instability Repair

Not Applicable

• Conditions: Recurrent Shoulder Dislocations
• Interventions: Procedure: Arthroscopic Bankart repair; Procedure: ABR+ARIC

• Registration Number: NCT00901797
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-05
• Study Start: 2009-05
• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-13
• Study First Posted: 2009-05-14
• Last Update Submitted: 2010-02-10
• Last Update Posted: 2010-02-11
• Primary Completion: 2010-05
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arthroscopic Bankart repair	Arthroscopic Bankart repair	-
ABR+ARIC	ABR+ARIC	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

TelAviv Suraski Medical Center; 🇮🇱 Tel-Aviv, Israel

Shoulder Unit, Orthopedics B Department, Tel Aviv medical center; 🇮🇱 Tel Aviv, Israel