Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158418
Status:
COMPLETED
Last Update Posted:
2009-01-29
First Post:
2005-09-07
Brief Title:
Cemented vs Non-Cemented TSA for OA of the Shoulder
Sponsor:
Fowler Kennedy Sport Medicine Clinic
Organization:
Fowler Kennedy Sport Medicine Clinic
Study Overview
Official Title:
Cemented Versus Uncemented Fixation of Humeral Components in Total Shoulder Arthroplasty for Osteoarthritis of the Shoulder
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to investigate the fixation of the humeral component in total shoulder arthroplasty for primary osteoarthritis of the glenohumeral jointOur 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
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 uncementedtissue-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
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 uncementedtissue-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCT-137451 | None | None | None |