Electrothermal Arthroscopic Capsulorrhaphy (ETAC) and Open Inferior Capsular Shift in Patients With Shoulder Instability
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|ClinicalTrials.gov Identifier: NCT00251160|
Recruitment Status : Completed
First Posted : November 9, 2005
Last Update Posted : July 13, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Dislocation||Procedure: Electrothermal arthroscopic capsulorrhaphy (ETAC) Procedure: Open inferior capsular shift (ICS)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Arthroscopic Electrothermal Capsulorrhaphy, ETAC, Versus Open Inferior Capsular Shift, ICS in Patients With Shoulder Instability: A Multicentre Randomized Clinical Trial|
|Study Start Date :||December 1999|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
|Active Comparator: ETAC||
Procedure: Electrothermal arthroscopic capsulorrhaphy (ETAC)
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.
Other Name: Heat probe
|Active Comparator: Open ICS||
Procedure: Open inferior capsular shift (ICS)
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.
Other Name: Open inferior capsular shift
- Western Ontario Shoulder Instability (WOSI) Index [ Time Frame: Baseline, 3, 6, 12, 24 months post-operatively ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251160
|University of Calgary Sport Medicine Centre|
|Calgary, Alberta, Canada, T2N 1N4|
|Grey Nuns Community Hospital|
|Edmonton, Alberta, Canada, T6L 5X8|
|Canada, British Columbia|
|Royal Columbian Hospital|
|New Westminster, British Columbia, Canada, V3L 3W7|
|Pan Am Medical and Surgical Centre|
|Winnipeg, Manitoba, Canada, R3M 3E4|
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 5G8|
|Fowler Kennedy Sport Medicine Centre|
|London, Ontario, Canada, N6A 3K7|
|St. Joseph's Health Centre|
|London, Ontario, Canada, N6A 4L6|
|Principal Investigator:||Nicholas Mohtadi, MD, FRCSC||University of Calgary Sport Medicine Centre|