Comparison of Two Methods of Fixation of Subscapularis During Shoulder Arthroplasty
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All trials for Subscapularis Peel All trials for Morselized Osteotomy All trials of subscapularis peel All trials of osteotomy
-Summary
This pilot study is being conducted to compare 2 methods of access to the shoulder for arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.
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+Detailed description
The study investigates the difference in disease specific quality of life between patients who undergo a subscapularis peel versus morselized osteotomy of the lesser tuberosity, as measured by the Western Ontario Osteoarthritis of the Shoulder (WOOS) at one year post-operatively in patients who undergo shoulder arthroplasty ?
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| subscapularis peel | Active comparator | Procedure: subscapularis peel | |
| osteotomy | Active comparator | Procedure: osteotomy | |
- subscapularis peel (Procedure), also known as non applicable: Detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel".
- osteotomy (Procedure), also known as non applicable: This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.
+Outcome measures
Primary outcomes
- Subscapularis Strength [2 years]: Subscapularis muscle strength will be measured with an electronic handheld dynamometer. Patients are asked to press the dynamometer in towards their chest (belly-press) for a period of approximately 3 seconds before releasing. Strength is measured in kilograms of force.
Secondary outcomes
- Western Ontario Osteoarthritis of the Shoulder Index [2 Years]: The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
- American Shoulder and Elbow Score [2 Years]: The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Patients who have failed standard non-surgical management of their shoulder arthritis who would benefit from a shoulder arthroplasty.
Exclusion Criteria:
* Active joint or systemic infection
* Significant muscle paralysis
* Rotator cuff tear arthroplasty
* Major medical illness
* Unable to speak or read English/French
* Psychiatric illness that precludes informed consent
* Unwilling to be followed for 1 year
+Posted results
Participant flow
| Milestone | Subscapularis Peel | Osteotomy |
|---|
| Started | 44 | 43 |
| Completed | 40 | 37 |
| Not completed | 4 | 6 |
Outcome results
- Subscapularis Strength (Primary), Mean, kg: Osteotomy 4.4 +/- 2.9; Subscapularis Peel 5.5 +/- 2.6
- Western Ontario Osteoarthritis of the Shoulder Index (Secondary), Mean, WOOS Score: Osteotomy 86.5 +/- 16; Subscapularis Peel 88.2 +/- 16.5
- American Shoulder and Elbow Score (Secondary), Mean, ASES Score: Osteotomy 79.4 +/- 24.6; Subscapularis Peel 83.3 +/- 19
Adverse events
Time frame: Adverse events were monitored through to participant study completion up until 2-years post-operative
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Subscapularis Peel | 0 | 0/44 (0.0%) | 0/44 (0.0%) |
| Osteotomy | 0 | 0/43 (0.0%) | 0/43 (0.0%) |
+Locations (1)
| Facility | City | Country | Status |
|---|
| The Ottawa Hosptial | Ottawa, Ontario | Canada | |
+Publications
- Results publication: Lapner PL, Sabri E, Rakhra K, Bell K, Athwal GS. Healing rates and subscapularis fatty infiltration after lesser tuberosity osteotomy versus subscapularis peel for exposure during shoulder arthroplasty. J Shoulder Elbow Surg. 2013 Mar;22(3):396-402. doi: 10.1016/j.jse.2012.05.031. Epub 2012 Sep 1. PMID 22944077
- Results publication: Lapner PL, Sabri E, Rakhra K, Bell K, Athwal GS. Comparison of lesser tuberosity osteotomy to subscapularis peel in shoulder arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2012 Dec 19;94(24):2239-46. doi: 10.2106/JBJS.K.01365. PMID 23318614
+Investigators