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Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00508105
First Posted: July 27, 2007
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. P. Lapner, Ottawa Hospital Research Institute
  Purpose
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 Intervention
Tenotomy Morselized Osteotomy Procedure: tenotomy Procedure: osteotomy

Study Type: Interventional
Study Design: 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

Further study details as provided by Dr. P. Lapner, Ottawa Hospital Research Institute:

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

Enrollment: 87
Study Start Date: November 2006
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 ?
  Eligibility

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 Submitted: July 25, 2007
First Posted: July 27, 2007
Last Update Posted: October 18, 2017
Last Verified: April 2012

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