Bankart LesionsNCT01620619
The Role of Rotator Interval Closure in Bankart Lesion Repair
A study testing Arthroscopic Bankart Repair alone and Closure of rotator interval in people with Bankart Lesions and Anterior Shoulder Instability, run by University of Western Ontario, Canada at 1 site in Canada.
Trial summary
The null hypothesis is that there is no statistical difference between the two treatment groups for any outcome. The investigators suspect that patients who undergo a Bankart lesion repair with rotator interval closure will have lower quality of life and less external rotation compared to patients who undergo a… Read more about this study
- Who is it for?
- Ages 15 to 51 years
- Conditions the study is for
- Bankart Lesions, Anterior Shoulder Instability
- What is being tested?
- Arthroscopic Bankart Repair alone and Closure of rotator interval
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to May 2016
- 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 15 to 51 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients between the ages of 15 to 50 years
- At least one episode of demonstrated dislocation
- Bankart lesion of the anterior glenoid labrum
- Absence of other capsular and tendon injuries
- Absence of glenoid fractures or divots
Who cannot join
- Posterior instability or the need for posterior surgical reconstruction
- Significant bone lesions greater than 3mm of the humeral head anterior-to- posterior (Hill-Sachs lesions)
- Presence of other pathologic conditions of the shoulder (excluding SLAP lesions)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
London Health Sciences Centre - Unviersity Hospital
London, Ontario
Robert Litchfield, MD, FRCSC
Kevin Willits, MD, FRCSC
About this study
The null hypothesis is that there is no statistical difference between the two treatment groups for any outcome. The investigators suspect that patients who undergo a Bankart lesion repair with rotator interval closure will have lower quality of life and less external rotation compared to patients who undergo a Bankart lesion repair alone. No difference will be observed for recurrence rate between the two treatment groups
Read the detailed description
Research assessing the role and effectiveness of rotator interval closure is important to attempt to determine the most beneficial and efficient treatment for Bankart lesions and anterior shoulder instability. To date there is only weak evidence supporting the superiority of Bankart lesion repair in addition to rotator interval closure compared to Bankart lesion repair alone.
Does Bankart lesion repair with rotator interval closure result in differences in quality of life, range of motion and recurrence at 3 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years in similar patients with Bankart lesions who are treated with Bankart lesion repair alone?
- Conditions
- Bankart Lesions, Anterior Shoulder Instability
- Being tested
- Arthroscopic Bankart Repair alone, Closure of rotator interval
- Keywords
- Shoulder, Bankart, Anterior Instability, Rotator Cuff
- Medical subject headings
- Bankart Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Bankart Repair aloneOther
Usual arthroscopic Bankart repair
Closure of rotator intervalProcedure or surgery
Usual arthroscopic Bankart repair plus rotator cuff interval closure
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Bankart Repair & Rotator Interval Closure | Active comparator | Not described Receives: Procedure: Closure of rotator interval |
| Arthoscopic Bankart Repair alone | Active comparator | Not described Receives: Other: Arthroscopic Bankart Repair alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Shoulder Instability Index
Disease-specific quality of life measurement tool (21 questions, 4 domains)
Measured: 3,6 weeks;3,6 months; 1,2 years
Secondary outcomes (4)
Range of Motion
- Universal goniometer
- Internal \& external ROM at neutral (0°) and 90° of abduction
- Both active and passive ROM at both positions
Measured: 3,6 months; 1-2 years
4-Item Pain Intensity Measure
Pain intensity in the morning, afternoon, evening and with activity
Measured: 3,6, weeks; 3, 6 months; 1,2 years
Upper Extremity Functional Index
Limb-specific quality of life measurement tool (20 questions)
Measured: 3,6 weeks; 3,6 months; 1,2 years
Recurrence
Patient-reported re-dislocation
Measured: 3,6 weeks; 3,6 months; 1,2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startFeb 2010
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bankart LesionsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dianne Bryant, University of Western Ontario, Canada
- Investigators
- Dianne Bryant, PhD, Study director, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620619
- Sponsor's protocol ID
- FKSMC 2010 - 4
- Status last verified
- Apr 2014
- First submitted
- 4 Jun 2012
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Rotator Interval Closure in Bankart Lesion Repair
- ClinicalTrials.gov ID
- NCT01620619
- Acronym / sponsor ID
- FKSMC 2010 - 4
- Conditions
- Bankart Lesions, Anterior Shoulder Instability
- Keywords
- Shoulder, Bankart, Anterior Instability, Rotator Cuff
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- May 2016 (estimated)
- First posted
- 15 Jun 2012 (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.
The null hypothesis is that there is no statistical difference between the two treatment groups for any outcome. The investigators suspect that patients who undergo a Bankart lesion repair with rotator interval closure will have lower quality of life and less external rotation compared to patients who undergo a Bankart lesion repair alone. No difference will be observed for recurrence rate between the two treatment groups
Detailed description
Research assessing the role and effectiveness of rotator interval closure is important to attempt to determine the most beneficial and efficient treatment for Bankart lesions and anterior shoulder instability. To date there is only weak evidence supporting the superiority of Bankart lesion repair in addition to rotator interval closure compared to Bankart lesion repair alone.
Does Bankart lesion repair with rotator interval closure result in differences in quality of life, range of motion and recurrence at 3 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years in similar patients with Bankart lesions who are treated with Bankart lesion repair alone?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Bankart Repair & Rotator Interval Closure | Active comparator | Procedure: Closure of rotator interval |
| Arthoscopic Bankart Repair alone | Active comparator | Other: Arthroscopic Bankart Repair alone |
Who may qualify
- Ages
- 15 to 51 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients between the ages of 15 to 50 years
- At least one episode of demonstrated dislocation
- Bankart lesion of the anterior glenoid labrum
- Absence of other capsular and tendon injuries
- Absence of glenoid fractures or divots
Key exclusion criteria (3 listed)
- Posterior instability or the need for posterior surgical reconstruction
- Significant bone lesions greater than 3mm of the humeral head anterior-to- posterior (Hill-Sachs lesions)
- Presence of other pathologic conditions of the shoulder (excluding SLAP lesions)
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 Repair aloneUsual arthroscopic Bankart repair | Other | Arthoscopic Bankart Repair alone |
| Closure of rotator intervalUsual arthroscopic Bankart repair plus rotator cuff interval closure | Procedure or surgery | Arthroscopic Bankart Repair & Rotator Interval Closure |
Primary outcome
Western Ontario Shoulder Instability Index
Time frame: 3,6 weeks;3,6 months; 1,2 years
Disease-specific quality of life measurement tool (21 questions, 4 domains)
4 secondary outcomes
Range of Motion
Time frame: 3,6 months; 1-2 years
4-Item Pain Intensity Measure
Time frame: 3,6, weeks; 3, 6 months; 1,2 years
Upper Extremity Functional Index
Time frame: 3,6 weeks; 3,6 months; 1,2 years
Recurrence
Time frame: 3,6 weeks; 3,6 months; 1,2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
Related trials for Bankart Lesions
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
Not yet recruitingObservational study
Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes (SALTO)
Anterior Shoulder Dislocation, Shoulder Dislocation Closed Traumatic
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.
Dianne Bryant, PhD study director
The University of Western Ontario
1 site 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 alone and Closure of rotator interval in people with Bankart Lesions and Anterior Shoulder Instability, run by University of Western Ontario, Canada at 1 site in Canada.
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 5 inclusion and 3 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 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Contact Dianne Bryant, PhD (5196612111 ext. 83947, dianne.bryant@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Shoulder Instability Index (time frame: 3,6 weeks;3,6 months; 1,2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2014.