Cemented vs. Non-Cemented TSA for OA of the Shoulder

This study has been completed.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by:
Fowler Kennedy Sport Medicine Clinic
ClinicalTrials.gov Identifier:
NCT00158418
First received: September 7, 2005
Last updated: January 28, 2009
Last verified: September 2005
  Purpose

The purpose of the study is to investigate the fixation of the humeral component in total shoulder arthroplasty for primary osteoarthritis of the glenohumeral joint.Our hypothesis is that uncemented fixation of the humerus will result in better disease-specific quality of life, decreased incidence of radiographic loosening, decrease operative time and no increase in complications.


Condition Intervention Phase
Osteoarthritis
Procedure: Cemented Humeral Stem
Procedure: Uncemented Humeral Stem
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Cemented Versus Uncemented Fixation of Humeral Components in Total Shoulder Arthroplasty for Osteoarthritis of the Shoulder

Resource links provided by NLM:


Further study details as provided by Fowler Kennedy Sport Medicine Clinic:

Primary Outcome Measures:
  • disease specific quality of life comparing the 2 groups at 2 years using several shoulder function rating scales.
  • the Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
  • the Constant Score
  • American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form.
  • Short Form-12

Secondary Outcome Measures:
  • the evaluation of radiolucent lines indicative of implant loosening
  • the incidence of revision surgery complications

Estimated Enrollment: 160
Study Start Date: August 2002
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Currently, cement fixation of the humeral component is recommended as the standard of care and review of the literature indicates that this fixation is associated with a low complication rate. Uncemented fixation is promising in its potential to provide long-term, stable fixation yet comparative results to cemented stems are not available at this time.

Despite an absence of data to support their use, there has been an exponential increase in the use of uncemented humeral component fixation in shoulder arthroplasty. This push may be dictated by the desire to reduce operative time in an attempt to cut surgical expenses. This goal is particularly highlighted by the efforts of government and third party bodies to maximize return on limited funds. There is no conclusive clinical data at this time to suggest that uncemented fixation yields results that are better than cemented fixation in the shoulder.

This multi-centre, prospective, randomized double blinded clinical trial will compare cemented versus uncemented/tissue-ingrowth fixation of the humeral component in total shoulder arthroplasty. Patients are recruited from 10 centres across Canada by surgeons with extensive experience in total shoulder arthroplasty. Patients will be randomized to receive either a cemented or uncemented humeral stem. All other variables will be controlled for.

The main evaluation of patient outcome is disease-specific quality of life. Validated tools evaluating shoulder function are being used for this purpose, as required by various societies. These include the Western Ontario Osteoarthritis of the Shoulder Index (WOOS), the most responsive; Constant, preferred by European investigators; American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment and Shoulder Score Index, preferred by the ASES. Overall global health status is measured using the SF-36. Several secondary outcomes are monitored for during the post-operative course. These are: shoulder function, radiographic evaluation of component fixation, operative time and the incidence of revision surgery and complications.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Primary osteoarthritis of the shoulder of grade III or higher (Kellgren and Lawrence modified for the shoulder
  2. Patients who have failed standard conservative management of their shoulder osteoarthritis

Exclusion Criteria:

  1. Patients with secondary OA resulting from major joint trauma, infection, avascular necrosis, cuff tear arthropathy, chronic dislocation, massive rotator cuff tear, inflammatory arthropathy, Charcot's arthropathy or previous shoulder surgery (other than arthroscopic debridement)
  2. Patients with preoperative CT scans of the shoulder which show insufficient glenoid bone stock that would not allow for implantation of a glenoid prosthesis
  3. Active joint or systemic infection
  4. Significant muscle paralysis
  5. Major medical illness (life expectancy less then 2yrs or unacceptably high operative risk)
  6. Unable to speak or read English/French
  7. Psychiatric illness that precludes informed consent
  8. Unwilling to be followed for 2 years
  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: NCT00158418

Locations
Canada, Ontario
Fowler Kennedy Sport Medicine Clinic
London, Ontario, Canada, N6A 3K7
Sponsors and Collaborators
Fowler Kennedy Sport Medicine Clinic
Zimmer, Inc.
Investigators
Principal Investigator: Robert B Litchfield, MD, FRCSC Fowler Kennedy Sport Medicine Clinic
  More Information

Publications:
Cofield RH, Daly PJ. Total Shoulder Arthroplasty with a Tissue-Ingrowth Glenoid Component. JSES, 1:77, 1992.
Richards RR, An K, Bigliani LU, Friedman R, Gartsman GM, Gridtina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A Standardized Method for the Assessment of Shoulder Function. JSES 3:347-352, 1994.
Kempf JF, Walch G, Lacaze F. Results of Shoulder Arthroplasty in Primary Glenohumeral Osteoarthritis. In Shoulder Arthroplasty. Springer-Verlag, Berlin, Germany, 1999, 203-210.
Kirkley A, Litchfield R, Patterson S, Lo I. Hemi vs. Total Shoulder Arthroplasty in Primary Shoulder Osteoarthritis. Annual meeting of the Canadian Orthopaedic Association, Edmonton, Alberta, June 2000.
Kreidie A.,Arthritis: a crisis for Canadians. Medical Post, May 16, 2000, pp 16.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Litchfield, FKSMC
ClinicalTrials.gov Identifier: NCT00158418     History of Changes
Other Study ID Numbers: FKSMC-CIHR-2, UCT-137451
Study First Received: September 7, 2005
Last Updated: January 28, 2009
Health Authority: Canada: Health Canada

Keywords provided by Fowler Kennedy Sport Medicine Clinic:
osteoarthritis
shoulder
randomized trial
cement

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014