Shoulder DislocationNCT00251160
Electrothermal Arthroscopic Capsulorrhaphy (ETAC) and Open Inferior Capsular Shift in Patients With Shoulder Instability
A study testing Electrothermal arthroscopic capsulorrhaphy (ETAC) and Open inferior capsular shift (ICS) in people with Shoulder Dislocation, run by University of Calgary at 7 sites in Canada.
Trial summary
This trial will compare the effectiveness of electrothermal arthroscopic capsulorrhaphy (ETAC) to the current reference standard procedure, open inferior capsular shift (ICS), for the treatment of shoulder instability caused by ligamentous capsular redundancy. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Electrothermal arthroscopic capsulorrhaphy (ETAC) and Open inferior capsular shift (ICS)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 7 sitesCanada
- Study dates
- Dec 1999to Feb 2010
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ages 14 years or greater
- Diagnosis of MDI or MDL-AII. Diagnosis will require two or more of the following:
- Symptomatic translation (pain or discomfort) in one or more directions: anterior, inferior and/or posterior;
- Ability to elicit unwanted glenohumeral translations that reliably produce symptoms with one of the following tests: the anterior and posterior apprehension tests, the anterior and posterior load and shift tests, the fulcrum test, the relocation test, the Fukuda test, and/or the push-pull or stress test with the patient supine;
- Presence of a positive sulcus sign of 1 centimetre or greater gap that reproduces the patient's clinical symptoms of instability and should be both palpable and visible;
- Symptoms of instability: subluxation or dislocation.
Show all 9Show fewer
- Written informed consent
- Failed at least 6 months of non-operative treatment
- Confirmed capsular-ligamentous redundancy as determined by diagnostic arthroscopy examination.
Who cannot join
- Neurologic disorder (ie: axillary nerve injury; syringomyelia)
- Cases involving third party compensation
- Patients with primary posterior instability
- A bony abnormality (Hill Sachs/bony Bankart) on standard series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view
- Presence of a Bankart lesion on arthroscopic exam of the joint
- Presence of an unstable biceps anchor (ie: superior labral anterior and posterior [SLAP] lesion) on arthroscopic exam of the joint
- Presence of a full-thickness rotator cuff tear.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
University of Calgary Sport Medicine Centre
Calgary, Alberta, T2N 1N4
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8
Hamilton General Hospital
Hamilton, Ontario, L8L 5G8
Fowler Kennedy Sport Medicine Centre
London, Ontario, N6A 3K7
St. Joseph's Health Centre
London, Ontario, N6A 4L6
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Pan Am Medical and Surgical Centre
Winnipeg, Manitoba, R3M 3E4
About this study
Official title: Arthroscopic Electrothermal Capsulorrhaphy, ETAC, Versus Open Inferior Capsular Shift, ICS in Patients With Shoulder Instability: A Multicentre Randomized Clinical Trial
This trial will compare the effectiveness of electrothermal arthroscopic capsulorrhaphy (ETAC) to the current reference standard procedure, open inferior capsular shift (ICS), for the treatment of shoulder instability caused by ligamentous capsular redundancy. Multi-directional instability (MDI) and multi-directional laxity with anteroinferior instability (MDL-AII) are the two types of shoulder instabilities included in this trial.
Hypothesis: There is no difference in disease-specific quality of life between patients undergoing an ETAC versus an open ICS for the treatment of shoulder instability caused by capsular ligamentous redundancy.
Read the detailed description
The shoulder is the most frequently dislocated joint in the body. Multiple causes and pathologies account for the various types of shoulder instability. Multi-directional instability (MDI) and multi-directional laxity with anteroinferior instability (MDL-AII) are similar in pathology, less common and more difficult to treat. These types of shoulder instability are caused by ligamentous capsular redundancy. When non-operative management fails for these patients, their quality of life is significantly impaired and surgical treatment is required to tighten the loose ligaments and joint capsule. A new way to treat these patients involves arthroscopic thermal shrinkage of the tissue to tighten the joint. However, there is a lack of scientific evidence to support the use of this technique called, electrothermal arthroscopic capsulorrhaphy (ETAC). The current reference (gold) standard treatment for these patients is an open inferior capsular shift (ICS) procedure. Therefore, this trial will compare the effectiveness of these surgical techniques (ETAC vs. ICS) in patients with MDI and MDL-AII by determining patient related quality of life.
This study is designed as a multicentre, randomized controlled trial. Patients diagnosed with either MDI or MDL-AII who failed standardized non-operative management will undergo a diagnostic shoulder arthroscopy, and if appropriate, will be subsequently randomized in the operating room to either an ETAC or ICS surgical procedure. Computer-generated, stratified block randomization is used. Stratification is based on two variables:
- surgeon - to account for any differences between surgeons, and
- diagnosis (MDI or MDL-AII) - to account for any differences in the severity of pathology.
The disease-specific quality of life is assessed using a validated questionnaire, the Western Ontario Shoulder Instability Index, measured at baseline, and 3, 6, 12 and 24 months. The WOSI index has 21 questions, divided into four categories to assess physical symptoms, sport/recreation/work, lifestyle and emotions. Each question is scored out of 100 using a visual analog scale response format. A lower score reflects a better quality of life.
- Conditions
- Shoulder Dislocation
- Being tested
- Electrothermal arthroscopic capsulorrhaphy (ETAC), Open inferior capsular shift (ICS)
- Keywords
- Multi-directional instability, MDI, Ligamentous laxity, Multi-directional laxity, MDL-AII, Shoulder instability, electrothermal capsulorrhaphy, ETAC, inferior capsular shift, ICS, capsular redundancy
- Medical subject headings
- Shoulder Dislocation, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrothermal arthroscopic capsulorrhaphy (ETAC)Procedure or surgery
Also called Heat probe
The Oratec Vulcan Generator electro-thermal system (Oratec Interventions Inc., Menlo Park, CA, USA) delivers heat at 75C and 40 watts. An anterior portal is established above the superior border of the subscapularis tendon. For MDI patients, the heat probe is introduced through the posterior portal. The capsule is shrunk using a grid pattern until excess volume is diminished. The extent of the heat probe application is identical to the landmarks used for the open ICS. Care is taken to avoid applying heat to the capsule in the region from 5-7 o'clock within 1cm of the glenoid rim to avoid the axillary nerve. The method of heat application utilizes a grid pattern, which is less likely to cause dissolution of the capsule and subsequent catastrophic capsular loss.
Open inferior capsular shift (ICS)Procedure or surgery
Also called Open inferior capsular shift
MDI: lateral capsule released antero-superiorly from rotator interval to equator, posteriorly on the humeral neck. MDL-AII: release from the rotator interval to 7 o'clock (Right) or 5 o'clock (Left) position on humeral neck, to tighten the 2 bands of the inferior GH ligaments, middle GH ligament and rotator interval. Bone adjacent to the articular surface on the surgical neck of the humerus is roughened to create a bleeding bony bed. With the arm in 0deg flexion, 30deg abduction, 30deg external rotation, the inferior leaflet of the capsule is shifted superiorly and slightly laterally, and sutured to the rim of the capsule using a non-absorbable suture. Superior leaflet is shifted inferiorly and sutured. Subscapularis is repaired at its anatomic length using interrupted sutures.
| Study group | Role | What they receive |
|---|---|---|
| ETAC | Active comparator | Not described Receives: Procedure: Electrothermal arthroscopic capsulorrhaphy (ETAC) |
| Open ICS | Active comparator | Not described Receives: Procedure: Open inferior capsular shift (ICS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Shoulder Instability (WOSI) Index
Measured: Baseline, 3, 6, 12, 24 months post-operatively
Secondary outcomes (5)
Constant score (European Shoulder Society)
Measured: Baseline, 3, 6, 12, 24 months post-operatively
Recurrent instability
Measured: Up to 24 months post-operatively
Complications
Measured: Intra-operatively and up to 8 weeks post-operatively
Operative time
Measured: Day of surgery
American Shoulder and Elbow Surgeon's Score (ASES)
Measured: Baseline, 3, 6, 12, 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2005 (estimated)
- Study startDec 1999
- Primary completionFeb 2010
- Study completionFeb 2010
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 Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Arthritis Society, Canada, Smith and Nephew (formerly Oratec Interventions)
- Responsible party
- Principal investigator, Dr. Nicholas Mohtadi, University of Calgary
- Investigators
- Nicholas Mohtadi, MD, FRCSC, Principal investigator, University of Calgary Sport Medicine Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251160
- Sponsor's protocol ID
- 10650
- Other IDs
- MCT-64671 (CIHR), ISRCTN68224911
- Status last verified
- Jul 2015
- First submitted
- 7 Nov 2005
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mohtadi NG, Hollinshead RM, Ceponis PJ, Chan DS, Fick GH. A multi-centre randomized controlled trial comparing electrothermal arthroscopic capsulorrhaphy versus open inferior capsular shift for patients with shoulder instability: protocol implementation and interim performance: lessons learned from conducting a multi-centre RCT [ISRCTN68224911; NCT00251160]. Trials. 2006 Feb 2;7:4. doi: 10.1186/1745-6215-7-4.
PubMed 16542033Mohtadi NG, Kirkley A, Hollinshead RM, McCormack R, MacDonald PB, Chan DS, Sasyniuk TM, Fick GH, Paolucci EO; Joint Orthopaedic Initiative for National Trials of the Shoulder-Canada. Electrothermal arthroscopic capsulorrhaphy: old technology, new evidence. A multicenter randomized clinical trial. J Shoulder Elbow Surg. 2014 Aug;23(8):1171-80. doi: 10.1016/j.jse.2014.02.022. Epub 2014 Jun 15.
PubMed 24939380
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Electrothermal Capsulorrhaphy, ETAC, Versus Open Inferior Capsular Shift, ICS in Patients With Shoulder Instability: A Multicentre Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00251160
- Acronym / sponsor ID
- 10650
- Conditions
- Shoulder Dislocation
- Keywords
- Multi-directional instability, MDI, Ligamentous laxity, Multi-directional laxity, MDL-AII, Shoulder instability, electrothermal capsulorrhaphy, ETAC, inferior capsular shift, ICS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Arthritis Society, Canada, Smith and Nephew (formerly Oratec Interventions)
- Study start
- Dec 1999
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 9 Nov 2005 (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.
This trial will compare the effectiveness of electrothermal arthroscopic capsulorrhaphy (ETAC) to the current reference standard procedure, open inferior capsular shift (ICS), for the treatment of shoulder instability caused by ligamentous capsular redundancy. Multi-directional instability (MDI) and multi-directional laxity with anteroinferior instability (MDL-AII) are the two types of shoulder instabilities included in this trial.
Hypothesis: There is no difference in disease-specific quality of life between patients undergoing an ETAC versus an open ICS for the treatment of shoulder instability caused by capsular ligamentous redundancy.
Detailed description
The shoulder is the most frequently dislocated joint in the body. Multiple causes and pathologies account for the various types of shoulder instability. Multi-directional instability (MDI) and multi-directional laxity with anteroinferior instability (MDL-AII) are similar in pathology, less common and more difficult to treat. These types of shoulder instability are caused by ligamentous capsular redundancy. When non-operative management fails for these patients, their quality of life is significantly impaired and surgical treatment is required to tighten the loose ligaments and joint capsule. A new way to treat these patients involves arthroscopic thermal shrinkage of the tissue to tighten the joint. However, there is a lack of scientific evidence to support the use of this technique called, electrothermal arthroscopic capsulorrhaphy (ETAC). The current reference (gold) standard treatment for these patients is an open inferior capsular shift (ICS) procedure. Therefore, this trial will compare the effectiveness of these surgical techniques (ETAC vs. ICS) in patients with MDI and MDL-AII by determining patient related quality of life.
This study is designed as a multicentre, randomized controlled trial. Patients diagnosed with either MDI or MDL-AII who failed standardized non-operative management will undergo a diagnostic shoulder arthroscopy, and if appropriate, will be subsequently randomized in the operating room to either an ETAC or ICS surgical procedure. Computer-generated, stratified block randomization is used. Stratification is based on two variables:
- surgeon - to account for any differences between surgeons, and
- diagnosis (MDI or MDL-AII) - to account for any differences in the severity of pathology.
The disease-specific quality of life is assessed using a validated questionnaire, the Western Ontario Shoulder Instability Index, measured at baseline, and 3, 6, 12 and 24 months. The WOSI index has 21 questions, divided into four categories to assess physical symptoms, sport/recreation/work, lifestyle and emotions. Each question is scored out of 100 using a visual analog scale response format. A lower score reflects a better quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETAC | Active comparator | Procedure: Electrothermal arthroscopic capsulorrhaphy (ETAC) |
| Open ICS | Active comparator | Procedure: Open inferior capsular shift (ICS) |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Ages 14 years or greater
- Diagnosis of MDI or MDL-AII. Diagnosis will require two or more of the following:
- Written informed consent
- Failed at least 6 months of non-operative treatment
- Confirmed capsular-ligamentous redundancy as determined by diagnostic arthroscopy examination.
Key exclusion criteria (7 listed)
- Neurologic disorder (ie: axillary nerve injury; syringomyelia)
- Cases involving third party compensation
- Patients with primary posterior instability
- A bony abnormality (Hill Sachs/bony Bankart) on standard series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view
- Presence of a Bankart lesion on arthroscopic exam of the joint
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 |
|---|---|---|
| Electrothermal arthroscopic capsulorrhaphy (ETAC)Also: Heat probeThe Oratec Vulcan Generator electro-thermal system (Oratec Interventions Inc., Menlo Park, CA, USA) delivers heat at 75C and 40 watts. An anterior portal is established above the superior border of the subscapularis tendon. For MDI patients, the heat probe is introduced through the posterior portal. The capsule is shrunk using a grid pattern until excess volume is diminished. The extent of the heat probe application is identical to the landmarks used for the open ICS. Care is taken to avoid applying heat to the capsule in the region from 5-7 o'clock within 1cm of the glenoid rim to avoid the axillary nerve. The method of heat application utilizes a grid pattern, which is less likely to cause dissolution of the capsule and subsequent catastrophic capsular loss. | Procedure or surgery | ETAC |
| Open inferior capsular shift (ICS)Also: Open inferior capsular shiftMDI: lateral capsule released antero-superiorly from rotator interval to equator, posteriorly on the humeral neck. MDL-AII: release from the rotator interval to 7 o'clock (Right) or 5 o'clock (Left) position on humeral neck, to tighten the 2 bands of the inferior GH ligaments, middle GH ligament and rotator interval. Bone adjacent to the articular surface on the surgical neck of the humerus is roughened to create a bleeding bony bed. With the arm in 0deg flexion, 30deg abduction, 30deg external rotation, the inferior leaflet of the capsule is shifted superiorly and slightly laterally, and sutured to the rim of the capsule using a non-absorbable suture. Superior leaflet is shifted inferiorly and sutured. Subscapularis is repaired at its anatomic length using interrupted sutures. | Procedure or surgery | Open ICS |
Primary outcome
Western Ontario Shoulder Instability (WOSI) Index
Time frame: Baseline, 3, 6, 12, 24 months post-operatively
5 secondary outcomes
Constant score (European Shoulder Society)
Time frame: Baseline, 3, 6, 12, 24 months post-operatively
Recurrent instability
Time frame: Up to 24 months post-operatively
Complications
Time frame: Intra-operatively and up to 8 weeks post-operatively
Operative time
Time frame: Day of surgery
American Shoulder and Elbow Surgeon's Score (ASES)
Time frame: Baseline, 3, 6, 12, 24 months post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
- Background: PubMed 16542033Mohtadi NG, Hollinshead RM, Ceponis PJ, Chan DS, Fick GH. A multi-centre randomized controlled trial comparing electrothermal arthroscopic capsulorrhaphy versus open inferior capsular shift for patients with shoulder instability: protocol implementation and interim performance: lessons learned from conducting a multi-centre RCT [ISRCTN68224911; NCT00251160]. Trials. 2006 Feb 2;7:4. doi: 10.1186/1745-6215-7-4.
- Results publication: PubMed 24939380Mohtadi NG, Kirkley A, Hollinshead RM, McCormack R, MacDonald PB, Chan DS, Sasyniuk TM, Fick GH, Paolucci EO; Joint Orthopaedic Initiative for National Trials of the Shoulder-Canada. Electrothermal arthroscopic capsulorrhaphy: old technology, new evidence. A multicenter randomized clinical trial. J Shoulder Elbow Surg. 2014 Aug;23(8):1171-80. doi: 10.1016/j.jse.2014.02.022. Epub 2014 Jun 15.
- Study protocol and Lessons learned from conducting a multi-centre RCT, in online journal "Trials"Link provided by the sponsor.
Related trials for Shoulder Dislocation
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
RecruitingObservational study
Prospective Descriptive Study of Injuries Associated to Anterior Shoulder Dislocations in Patients Over 40 Years
Anterior Glenohumeral Dislocations
Not yet recruiting
Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode.
Shoulder Dislocation
Recruiting
Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation
Return to Sport, Shoulder Dislocation or Subluxation
RecruitingObservational study
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Proximal Humeral Fracture, Fracture 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.
Nicholas Mohtadi, MD, FRCSC principal investigator
University of Calgary Sport Medicine Centre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrothermal arthroscopic capsulorrhaphy (ETAC) and Open inferior capsular shift (ICS) in people with Shoulder Dislocation, run by University of Calgary at 7 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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) Index (time frame: Baseline, 3, 6, 12, 24 months post-operatively). 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 NCT00251160, 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 13 Jul 2015.