Other Instability, ShoulderPhase 2NCT01324531
Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability
A Phase 2 study testing Bankart repair and remplissage and Bankart repair in people with Other Instability, Shoulder and Hill-Sachs Lesion, run by Panam Clinic at 2 sites in Canada.
Trial summary
The purpose of this prospective, randomized, controlled trial is to compare subjective patient-reported outcomes and objective clinical results between arthroscopic Bankart repair with and without arthroscopic infraspinatus remplissage in patients with anterior shoulder instability with a Hill-Sachs Defect. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Other Instability, Shoulder, Hill-Sachs Lesion
- What is being tested?
- Bankart repair and remplissage and Bankart repair
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2011to Aug 2024
- Phase
- Phase 2
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 14 years or older
- must have anterior shoulder instability and Hill-Sachs defect
- must have anterior instability with any engaging Hill Sachs Lesion on CT scan, MRI or ultrasound and no more than 15% glenoid bone loss
Who cannot join
- Glenoid defect >15% of AP diameter of glenoid
- significant shoulder comorbidities (i.e, OA, previous surgery other than previous instability)
- active joint or systemic infection
- significant muscle paralysis
- rotator cuff or Charcot's arthropathy
- significant medical comorbidity that may alter effectiveness of surgical intervention
Show all 10Show fewer
- major medical illness
- unable to speak French or English
- psychiatric illness that precludes informed consent
- unwilling to be followed for 2 years
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Ottawa/Ottawa Hospital
Ottawa, Ontario
Pan Am Clinic
Winnipeg, Manitoba, R3M 3E4
About this study
Official title: Arthroscopic Bankart Repair With and Without Arthroscopic Infraspinatus Remplissage in Anterior Shoulder Instability With a Hill-Sachs Defect: A Randomized Controlled Trial
The purpose of this prospective, randomized, controlled trial is to compare subjective patient-reported outcomes and objective clinical results between arthroscopic Bankart repair with and without arthroscopic infraspinatus remplissage in patients with anterior shoulder instability with a Hill-Sachs Defect.
Read the detailed description
Significant osseous defects of the glenohumeral joint can often lead to failure of arthroscopic shoulder stabilization procedures. The best treatment in the setting of shoulder instability with significant glenoid and/or humeral defects remains controversial. Several open procedures have been suggested, but arthroscopic methods have started to garner some attention in the literature. In patients with an engaging Hill-Sachs lesion without significant glenoid bone loss, arthroscopic remplissage consisting of arthroscopic posterior capsulodesis and infraspinatus tenodesis to fill the Hill-Sachs lesion has been proposed as a novel treatment method.
The authors believe it is scientifically necessary to investigate the role of addition of arthroscopic infraspinatus remplissage to the conventional arthroscopic Bankart repair. As more surgeons are trained in the technique, it will be performed more frequently. Increased patient awareness continues to lead to increasing demand for minimally invasive approaches. Arthroscopic remplissage brings with it an increase in operative time, with a theorized risk of reduction in dislocation risk. For these reasons, the authors believe that it is scientifically and fiscally necessary to determine the difference in outcome between arthroscopic Bankart repair with and without arthroscopic infraspinatus remplissage for patients with anterior shoulder instability and a Hill-Sachs defect in the framework of a prospective, randomized controlled study.
- Conditions
- Other Instability, Shoulder, Hill-Sachs Lesion
- Being tested
- Bankart repair and remplissage, Bankart repair
- Keywords
- Bankart repair, remplissage, Hill-Sachs defect, shoulder instability, anterior shoulder instability
- Medical subject headings
- Bankart Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bankart repair and remplissageProcedure or surgery
Bankart repair may be completed before or after remplissage. While maintaining camera in anterior-superior portal drill guide and anchor cannula is placed through the posterior portal into remplissage site. Anchor cannula with obturator is passed through infraspinatus tendon and posterior capsule via pre-existing portal, and first anchor is placed in inferior aspect of Hill-Sachs lesion.Once anchor is inserted, penetrating grasper is passed through tendon and posterior capsule, 1 cm inferior to the initial portal entry site, to grasp and pull 1 suture limb.Second anchor is placed in superior aspect of Hill-Sachs lesion and grasper penetrator is used in same fashion to pass 1 suture limb 1 cm superior to initial portal entry site. The inferior suture is tied first with knots remaining extraarticular in the subdeltoid space. The superior suture is tied to complete remplissage.
Bankart repairProcedure or surgery
Bankart repair based on surgeon's preference
| Study group | Role | What they receive |
|---|---|---|
| Bankart repair | Active comparator | Not described Receives: Procedure: Bankart repair |
| Bankart repair and remplissage | Active comparator | Not described Receives: Procedure: Bankart repair and remplissage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Shoulder Instability (WOSI) score
WOSI score questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems. Difference between study arm outcomes will be assessed using pre-op WOSI score as a covariate
Measured: 24 months post-surgery
Secondary outcomes (3)
Simple Shoulder Test
Simple Shoulder Test (SST) is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment. Differences between study arm outcomes will be assessed using pre-op SST scores as a covariate
Measured: 24 months post-surgery
American Shoulder and Elbow Society assessment (ASES)
The ASES assessment (patient report section) is a region-specific questionnaire designed for self-assessment of aspects of pain and function. Difference between study arm outcomes will be assessed using pre-op ASES score as a covariate
Measured: 24 months post-surgery
Ultrasound imaging
Ultrasound imaging will be conducted 24 months post-surgery and compared to pre-operative findings on CT-Scan, ultrasound and intraoperatively to establish extent of healing.
Measured: 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2019
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Other Instability, ShoulderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panam Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa, Western University, Canada, University of British Columbia
- Responsible party
- Principal investigator, Peter MacDonald, Panam Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324531
- Sponsor's protocol ID
- REMP 01
- Status last verified
- Apr 2024
- First submitted
- 23 Mar 2011
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Burkhart SS, De Beer JF. Traumatic glenohumeral bone defects and their relationship to failure of arthroscopic Bankart repairs: significance of the inverted-pear glenoid and the humeral engaging Hill-Sachs lesion. Arthroscopy. 2000 Oct;16(7):677-94. doi: 10.1053/jars.2000.17715.
PubMed 11027751Burkhart SS, Danaceau SM. Articular arc length mismatch as a cause of failed bankart repair. Arthroscopy. 2000 Oct;16(7):740-4. doi: 10.1053/jars.2000.7794.
PubMed 11027759Kropf EJ, Tjoumakaris FP, Sekiya JK. Arthroscopic shoulder stabilization: is there ever a need to open? Arthroscopy. 2007 Jul;23(7):779-84. doi: 10.1016/j.arthro.2007.03.004.
PubMed 17637415Woodmass JM, McRae S, Lapner P, Kamikovski I, Jong B, Old J, Marsh J, Dubberley J, Stranges G, Sasyniuk TM, MacDonald PB. Arthroscopic Bankart Repair With Remplissage in Anterior Shoulder Instability Results in Fewer Redislocations Than Bankart Repair Alone at Medium-term Follow-up of a Randomized Controlled Trial. Am J Sports Med. 2024 Jul;52(8):2055-2062. doi: 10.1177/03635465241254063. Epub 2024 Jun 14.
PubMed 38874505
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Bankart Repair With and Without Arthroscopic Infraspinatus Remplissage in Anterior Shoulder Instability With a Hill-Sachs Defect: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01324531
- Acronym / sponsor ID
- REMP 01
- Conditions
- Other Instability, Shoulder, Hill-Sachs Lesion
- Keywords
- Bankart repair, remplissage, Hill-Sachs defect, shoulder instability, anterior shoulder instability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Panam ClinicUniversity, hospital or other
- Collaborators
- University of Ottawa, Western University, Canada, University of British Columbia
- Study start
- Mar 2011
- Primary completion
- Jun 2019 (actual)
- Study completion
- Aug 2024 (estimated)
- First posted
- 29 Mar 2011 (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 purpose of this prospective, randomized, controlled trial is to compare subjective patient-reported outcomes and objective clinical results between arthroscopic Bankart repair with and without arthroscopic infraspinatus remplissage in patients with anterior shoulder instability with a Hill-Sachs Defect.
Detailed description
Significant osseous defects of the glenohumeral joint can often lead to failure of arthroscopic shoulder stabilization procedures. The best treatment in the setting of shoulder instability with significant glenoid and/or humeral defects remains controversial. Several open procedures have been suggested, but arthroscopic methods have started to garner some attention in the literature. In patients with an engaging Hill-Sachs lesion without significant glenoid bone loss, arthroscopic remplissage consisting of arthroscopic posterior capsulodesis and infraspinatus tenodesis to fill the Hill-Sachs lesion has been proposed as a novel treatment method.
The authors believe it is scientifically necessary to investigate the role of addition of arthroscopic infraspinatus remplissage to the conventional arthroscopic Bankart repair. As more surgeons are trained in the technique, it will be performed more frequently. Increased patient awareness continues to lead to increasing demand for minimally invasive approaches. Arthroscopic remplissage brings with it an increase in operative time, with a theorized risk of reduction in dislocation risk. For these reasons, the authors believe that it is scientifically and fiscally necessary to determine the difference in outcome between arthroscopic Bankart repair with and without arthroscopic infraspinatus remplissage for patients with anterior shoulder instability and a Hill-Sachs defect in the framework of a prospective, randomized controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bankart repair | Active comparator | Procedure: Bankart repair |
| Bankart repair and remplissage | Active comparator | Procedure: Bankart repair and remplissage |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 14 years or older
- must have anterior shoulder instability and Hill-Sachs defect
- must have anterior instability with any engaging Hill Sachs Lesion on CT scan, MRI or ultrasound and no more than 15% glenoid bone loss
Key exclusion criteria (10 listed)
- Glenoid defect >15% of AP diameter of glenoid
- significant shoulder comorbidities (i.e, OA, previous surgery other than previous instability)
- active joint or systemic infection
- significant muscle paralysis
- rotator cuff or Charcot's arthropathy
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 |
|---|---|---|
| Bankart repair and remplissageBankart repair may be completed before or after remplissage. While maintaining camera in anterior-superior portal drill guide and anchor cannula is placed through the posterior portal into remplissage site. Anchor cannula with obturator is passed through infraspinatus tendon and posterior capsule via pre-existing portal, and first anchor is placed in inferior aspect of Hill-Sachs lesion.Once anchor is inserted, penetrating grasper is passed through tendon and posterior capsule, 1 cm inferior to the initial portal entry site, to grasp and pull 1 suture limb.Second anchor is placed in superior aspect of Hill-Sachs lesion and grasper penetrator is used in same fashion to pass 1 suture limb 1 cm superior to initial portal entry site. The inferior suture is tied first with knots remaining extraarticular in the subdeltoid space. The superior suture is tied to complete remplissage. | Procedure or surgery | Bankart repair and remplissage |
| Bankart repairBankart repair based on surgeon's preference | Procedure or surgery | Bankart repair |
Primary outcome
Western Ontario Shoulder Instability (WOSI) score
Time frame: 24 months post-surgery
WOSI score questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems. Difference between study arm outcomes will be assessed using pre-op WOSI score as a covariate
3 secondary outcomes
Simple Shoulder Test
Time frame: 24 months post-surgery
American Shoulder and Elbow Society assessment (ASES)
Time frame: 24 months post-surgery
Ultrasound imaging
Time frame: 24 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 11027751Burkhart SS, De Beer JF. Traumatic glenohumeral bone defects and their relationship to failure of arthroscopic Bankart repairs: significance of the inverted-pear glenoid and the humeral engaging Hill-Sachs lesion. Arthroscopy. 2000 Oct;16(7):677-94. doi: 10.1053/jars.2000.17715.
- Background: PubMed 11027759Burkhart SS, Danaceau SM. Articular arc length mismatch as a cause of failed bankart repair. Arthroscopy. 2000 Oct;16(7):740-4. doi: 10.1053/jars.2000.7794.
- Background: PubMed 17637415Kropf EJ, Tjoumakaris FP, Sekiya JK. Arthroscopic shoulder stabilization: is there ever a need to open? Arthroscopy. 2007 Jul;23(7):779-84. doi: 10.1016/j.arthro.2007.03.004.
- Derived from this study: PubMed 38874505Woodmass JM, McRae S, Lapner P, Kamikovski I, Jong B, Old J, Marsh J, Dubberley J, Stranges G, Sasyniuk TM, MacDonald PB. Arthroscopic Bankart Repair With Remplissage in Anterior Shoulder Instability Results in Fewer Redislocations Than Bankart Repair Alone at Medium-term Follow-up of a Randomized Controlled Trial. Am J Sports Med. 2024 Jul;52(8):2055-2062. doi: 10.1177/03635465241254063. Epub 2024 Jun 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bankart repair and remplissage and Bankart repair in people with Other Instability, Shoulder and Hill-Sachs Lesion, run by Panam Clinic at 2 sites 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 3 inclusion and 10 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 2 Apr 2024. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Shoulder Instability (WOSI) score (time frame: 24 months post-surgery). 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 NCT01324531, which also lists 4 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 2 Apr 2024.