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

January 28, 2009 updated by: Fowler Kennedy Sport Medicine Clinic

Cemented Versus Uncemented Fixation of Humeral Components in Total Shoulder Arthroplasty for Osteoarthritis of the Shoulder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Fowler Kennedy Sport Medicine Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
the evaluation of radiolucent lines indicative of implant loosening
the incidence of revision surgery complications

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fowler Kennedy Sport Medicine Clinic

Collaborators

Zimmer Biomet

Investigators

  • Principal Investigator: Robert B Litchfield, MD, FRCSC, Fowler Kennedy Sport Medicine Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 29, 2009

Last Update Submitted That Met QC Criteria

January 28, 2009

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKSMC-CIHR-2
  • UCT-137451

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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