Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. P. Lapner, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00508105
First received: July 25, 2007
Last updated: April 11, 2012
Last verified: April 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Methods of Fixation of Subscapularis During Shoulder Arthroplasty

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • to assess quality of life post-operatively of each surgical group [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. P. Lapner, Principal Investigator, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00508105     History of Changes
Other Study ID Numbers: OHREB2006489-0H
Study First Received: July 25, 2007
Last Updated: April 11, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Osteoarthritis
Shoulder
tenotomy
ostotomy

ClinicalTrials.gov processed this record on October 23, 2014