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Arthroscopic Rotator Interval Closure in Shoulder Instability Repair

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ClinicalTrials.gov Identifier: NCT00901797
Recruitment Status : Unknown
Verified May 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : May 14, 2009
Last Update Posted : February 11, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Recurrent Shoulder Dislocations Procedure: Arthroscopic Bankart repair Procedure: ABR+ARIC Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2009
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]


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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Dr. maman Eran, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00901797     History of Changes
Other Study ID Numbers: Dr. Maman
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: February 11, 2010
Last Verified: May 2009

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:
Shoulder Dislocation
Recurrence
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries
Disease Attributes
Pathologic Processes