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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
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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
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 May 16, 2013