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Completed

NCT Number: NCT00508105

Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty

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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Key information

Conditions

Subscapularis Peel Arthritis Joint Diseases Morselized Osteotomy Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hosptial

Ottawa, Ontario, K1y 4E9, Canada

About this study

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 ?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

subscapularis peel

Procedure

Detachment of the subscapularis tendon from its insertion on the lesser tuberosity "the peel".

Other names: non applicable

osteotomy

Procedure

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.

Other names: non applicable

Primary outcomes

  1. Subscapularis Strength

    Time frame: 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

  1. Western Ontario Osteoarthritis of the Shoulder Index

    Time frame: 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.

  2. American Shoulder and Elbow Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

Comparison of Two Methods of Fixation of Subscapularis During Shoulder Arthroplasty

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jul 27, 2007
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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