Cemented vs. Non-Cemented TSA for OA of the Shoulder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00158418|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 29, 2009
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Procedure: Cemented Humeral Stem Procedure: Uncemented Humeral Stem||Phase 3|
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 (Clinical Trial)|
|Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Cemented Versus Uncemented Fixation of Humeral Components in Total Shoulder Arthroplasty for Osteoarthritis of the Shoulder|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
- 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
- the evaluation of radiolucent lines indicative of implant loosening
- the incidence of revision surgery complications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00158418
|Fowler Kennedy Sport Medicine Clinic|
|London, Ontario, Canada, N6A 3K7|
|Principal Investigator:||Robert B Litchfield, MD, FRCSC||Fowler Kennedy Sport Medicine Clinic|