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

July 25, 2007
April 11, 2012
November 2006
December 2011   (final data collection date for primary outcome measure)
to assess quality of life post-operatively of each surgical group [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00508105 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty
Comparison of Two 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.

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 ?

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Tenotomy
  • Morselized Osteotomy
  • 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
  • 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
  • Active Comparator: tenotomy
    Intervention: Procedure: tenotomy
  • Active Comparator: osteotomy
    Intervention: Procedure: osteotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00508105
OHREB2006489-0H
No
Dr. P. Lapner, Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Not Provided
Principal Investigator: Peter Lapner, MD OHRI
Ottawa Hospital Research Institute
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP