Arthroscopic Rotator Interval Closure in Shoulder Instability Repair
Primary Purpose
Recurrent Shoulder Dislocations
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Arthroscopic Bankart repair
ABR+ARIC
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Shoulder Dislocations focused on measuring 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
Eligibility 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
Sites / Locations
- Shoulder Unit, Orthopedics B Department, Tel Aviv medical centerRecruiting
- TelAviv Suraski Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arthroscopic Bankart repair
ABR+ARIC
Arm Description
Outcomes
Primary Outcome Measures
Recurrent shoulder dislocation or instability symptoms
Secondary Outcome Measures
Post operative range of motion (ROM)
Activity level
Need for recurrent surgery
Pain
Full Information
NCT ID
NCT00901797
First Posted
May 13, 2009
Last Updated
February 10, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00901797
Brief Title
Arthroscopic Rotator Interval Closure in Shoulder Instability Repair
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
May 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Although Hyperlax patients undergoing ABR have higher incidence of recurrent shoulder dislocations than those without hyperlaxity, adding ARIC will lower the recurrent dislocation rate.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arthroscopic Bankart repair
Arm Type
Active Comparator
Arm Title
ABR+ARIC
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Bankart repair
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ABR+ARIC
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Shoulder Unit, Orthopedics B Department, Tel Aviv medical center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eran Maman, MD
Phone
36974727
Ext
972
Email
dremaman@gmail.com
Facility Name
TelAviv Suraski Medical Center
City
Tel-Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eran Maman, MD
Phone
972-524266333
Email
dremaman@gmail.com
First Name & Middle Initial & Last Name & Degree
Oleg Dolkart, MSc
Phone
972-524262544
Email
dolk1974@yahoo.com
First Name & Middle Initial & Last Name & Degree
Eran maman, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
14984192
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. doi: 10.1016/s0030-5898(03)00091-9.
Results Reference
background
PubMed Identifier
17560472
Citation
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.
Results Reference
background
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Arthroscopic Rotator Interval Closure in Shoulder Instability Repair
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