Total Knee Arthroplasty Clinical Trial
Official title:
Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study
Verified date | March 2019 |
Source | Smith & Nephew, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
Status | Completed |
Enrollment | 1694 |
Est. completion date | September 24, 2018 |
Est. primary completion date | January 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Subject received primary uni- or bi-lateral total knee arthroplasty with the Journey II BCS Total Knee System for approved indication - The TKA occurred at least 12 weeks prior to enrollment - Subject records contain Patient Reported Outcome data obtained =3 months prior to as well as =6 months post-enrollment. Exclusion Criteria: - Subject received the JOURNEY II BCS Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty |
Country | Name | City | State |
---|---|---|---|
Belgium | Jesse Ziekenhuis | Hasselt | |
Belgium | UZ Leuven Campus | Pellenberg | |
Switzerland | Christen Ortho AG | Bern | |
United States | University of Colorado Orthopaedics | Aurora | Colorado |
United States | Providence Regional Medical Center | Everett | Washington |
United States | Andrews Research and Education Foundation | Gulf Breeze | Florida |
United States | Methodist Sports Medicine | Indianapolis | Indiana |
United States | TN Orthopaedic Foundation for Education and Research | Knoxville | Tennessee |
United States | Hospital for Special Surgery | New York | New York |
United States | San Antonio Orthopaedic Specialists | San Antonio | Texas |
United States | University Orthopaedics Center | State College | Pennsylvania |
United States | Marra Knee and Shoulder Center | Wheeling | West Virginia |
Lead Sponsor | Collaborator |
---|---|
Smith & Nephew, Inc. |
United States, Belgium, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Revision Rate of Total Knee System | Number of revisions | implantation through study completion, approximately 3 years | |
Secondary | Adverse Events | Number of adverse events reported per ISO 14155 guidelines | implantation through study completion, approximately 3 years | |
Secondary | Health care utilization: Hospitalization | Length of hospital stay for primary (index) surgery | implantation through study completion, approximately 3 years | |
Secondary | Health care utilization: Hospitalization | Hospitalizations (admission for inpatient care) occurring after the hospitalization for the index surgery (number and length of stay) | implantation through study completion, approximately 3 years | |
Secondary | Health care utilization: Rehabilitation | number of sessions and duration of rehabilitation in weeks | implantation through study completion, approximately 3 years | |
Secondary | Health care utilization: Outpatient visits | Number and type of outpatient visits | implantation through study completion, approximately 3 years | |
Secondary | Health Care Utilization: Re-operations | number of re-operations and revisions | implantation through study completion, approximately 3 years | |
Secondary | Patient reported outcomes | EQ-5D-3L | implantation through study completion, approximately 3 years | |
Secondary | Clinical outcomes | Knee Society Score | implantation through study completion, approximately 3 years | |
Secondary | Return to Work | Changes in employment status will be recorded with the date on which the change occurred and the change status. | implantation through study completion, approximately 3 years | |
Secondary | Technical Difficulties Encountered During Device Implantation | Number of technical difficulties encountered with the device | implantation through study completion, approximately 3 years |
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