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Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty

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ClinicalTrials.gov Identifier: NCT00508105
Recruitment Status : Completed
First Posted : July 27, 2007
Last Update Posted : April 12, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Tenotomy Morselized Osteotomy Procedure: tenotomy Procedure: osteotomy

Detailed Description:
The study investigates the difference in disease specific quality of life between patients who undergo a subscapularis tenotomy 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 ?

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Methods of Fixation of Subscapularis During Shoulder Arthroplasty
Study Start Date : November 2006
Primary Completion Date : December 2011
Study Completion Date : December 2011
Arms and Interventions

Arm Intervention/treatment
Active Comparator: tenotomy Procedure: tenotomy
This treatment group will undergo a technique that involves division of the tendon to gain access to the shoulder.
Other Name: non applicable
Active Comparator: osteotomy Procedure: osteotomy
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 Name: non applicable


Outcome Measures

Primary Outcome Measures :
  1. to assess quality of life post-operatively of each surgical group [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 muscel paralysis
  • Rotator cuff tear arthroplathy
  • Major medical illness
  • Unable to speak or read English/French
  • Psychiatric illness that precludes informed consent
  • Unwilling to be followed for 1 year
Contacts and Locations

Information from the National Library of Medicine

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): NCT00508105


Locations
Canada, Ontario
The Ottawa Hosptial
Ottawa, Ontario, Canada, K1y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Peter Lapner, MD OHRI
More Information

Responsible Party: Dr. P. Lapner, Principal Investigator, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00508105     History of Changes
Other Study ID Numbers: OHREB2006489-0H
First Posted: July 27, 2007    Key Record Dates
Last Update Posted: April 12, 2012
Last Verified: April 2012

Keywords provided by Dr. P. Lapner, Ottawa Hospital Research Institute:
Osteoarthritis
Shoulder
tenotomy
ostotomy