Recurrent Shoulder DislocationsNCT00901797
Arthroscopic Rotator Interval Closure in Shoulder Instability Repair
A study testing Arthroscopic Bankart repair and ABR+ARIC in people with Recurrent Shoulder Dislocations, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Recurrent Shoulder Dislocations
- What is being tested?
- Arthroscopic Bankart repair and ABR+ARIC
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2009to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 16-40 years old
- Anterior Shoulder instability
- Hyperlaxity (general and shoulder laxity)
Who cannot join
- Previous humerus/glenoid fracture
- large bony "Bankart"
- Previous shoulder operation
- Adhesive capsulitis-Habitual dislocations
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Shoulder Unit, Orthopedics B Department, Tel Aviv medical center
Tel Aviv
Eran Maman, MD, 36974727 ext. 972, dremaman@gmail.com
- Recruiting
TelAviv Suraski Medical Center
Tel Aviv
Eran Maman, MD, 972-524266333, dremaman@gmail.com
Oleg Dolkart, MSc, 972-524262544, dolk1974@yahoo.com
About this study
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.
- Conditions
- Recurrent Shoulder Dislocations
- Being tested
- Arthroscopic Bankart repair, ABR+ARIC
- 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
- Medical subject headings
- Shoulder Dislocation, Bankart Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Bankart repairProcedure or surgery
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.
ABR+ARICProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Bankart repair | Active comparator | Not described Receives: Procedure: Arthroscopic Bankart repair |
| ABR+ARIC | Active comparator | Not described Receives: Procedure: ABR+ARIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent shoulder dislocation or instability symptoms
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recurrent Shoulder DislocationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901797
- Sponsor's protocol ID
- Dr. Maman
- Status last verified
- May 2009
- First submitted
- 13 May 2009
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14984192Provencher 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.
PubMed 17560472
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Rotator Interval Closure in Shoulder Instability Repair
- ClinicalTrials.gov ID
- NCT00901797
- Acronym / sponsor ID
- Dr. Maman
- Conditions
- Recurrent Shoulder Dislocations
- Keywords
- ABD, ABDuction, ABR, Arthroscopic Bankart Repair, ACJ, AcromioClavicular Joint, AD, Anterior Drawer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- May 2009
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 14 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Bankart repair | Active comparator | Procedure: Arthroscopic Bankart repair |
| ABR+ARIC | Active comparator | Procedure: ABR+ARIC |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 16-40 years old
- Anterior Shoulder instability
- Hyperlaxity (general and shoulder laxity)
Key exclusion criteria (4 listed)
- Previous humerus/glenoid fracture
- large bony "Bankart"
- Previous shoulder operation
- Adhesive capsulitis-Habitual dislocations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic Bankart repairSeated 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. | Procedure or surgery | Arthroscopic Bankart repair |
| ABR+ARICSeated 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. | Procedure or surgery | ABR+ARIC |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2010.
- Background: PubMed 14984192Stokes 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.
- Background: PubMed 17560472Provencher 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.
Related trials for Recurrent Shoulder Dislocations
Active, not recruiting
Remplissage Versus Latarjet Coracoid Transfer for Recurrent Shoulder Instability
Shoulder Dislocation
Recruiting
Surgical Treatment of Recurrent Shoulder Dislocations
Shoulder Instability
Active, not recruitingObservational study
MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.
Other Instability, Shoulder, Dislocations
Not yet recruitingObservational study
Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes (SALTO)
Anterior Shoulder Dislocation, Shoulder Dislocation Closed Traumatic
Recruiting
Latarjet Versus Modified Eden-Hybinette for Anterior Shoulder Dislocation
Shoulder Dislocation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shoulder Unit, Orthopedics B Department, Tel Aviv medical center
Tel Aviv, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic Bankart repair and ABR+ARIC in people with Recurrent Shoulder Dislocations, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00901797, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2010.