Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Arthroscopic Rotator Interval Closure in Shoulder Instability Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00901797
First received: May 13, 2009
Last updated: February 10, 2010
Last verified: May 2009
  Purpose

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.

Condition Intervention
Recurrent Shoulder Dislocations
Procedure: Arthroscopic Bankart repair
Procedure: ABR+ARIC

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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arthroscopic Bankart repair 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.
Active Comparator: ABR+ARIC 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.

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901797

Locations
Israel
Shoulder Unit, Orthopedics B Department, Tel Aviv medical center Recruiting
Tel Aviv, Israel
Contact: Eran Maman, MD    36974727 ext 972    dremaman@gmail.com   
TelAviv Suraski Medical Center Recruiting
Tel-Aviv, Israel
Contact: Eran Maman, MD    972-524266333    dremaman@gmail.com   
Contact: Oleg Dolkart, MSc    972-524262544    dolk1974@yahoo.com   
Principal Investigator: Eran maman, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

Publications:
Responsible Party: Dr. maman Eran, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00901797     History of Changes
Other Study ID Numbers: Dr. Maman
Study First Received: May 13, 2009
Last Updated: February 10, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
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

Additional relevant MeSH terms:
Dislocations
Recurrence
Shoulder Dislocation
Arm Injuries
Disease Attributes
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on November 19, 2014