Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty

NCT00508105 — Not applicable, Completed, 87 participants, Ottawa Hospital Research Institute

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Comparison of Two Methods of Fixation of Subscapularis During Shoulder Arthroplasty

RegistryNCT00508105
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment87 (Actual)
SponsorOttawa Hospital Research Institute (Other)
ConditionsSubscapularis Peel, Morselized Osteotomy
Interventionssubscapularis peel, osteotomy (Procedure)
Datesstart 2006-11-01, primary completion 2011-12-01, completion 2011-12-01, first posted 2007-07-27, last updated 2020-05-05
Locations1 site in Canada

Related Papers Related Patents Related Grants Related Experts
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

ArmTypeInterventionsDescription
subscapularis peelActive comparatorProcedure: subscapularis peel
osteotomyActive comparatorProcedure: 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

MilestoneSubscapularis PeelOsteotomy
Started4443
Completed4037
Not completed46

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

ArmDeathsSerious adverse eventsOther adverse events
Subscapularis Peel00/44 (0.0%)0/44 (0.0%)
Osteotomy00/43 (0.0%)0/43 (0.0%)

+Locations (1)

FacilityCityCountryStatus
The Ottawa HosptialOttawa, OntarioCanada

+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