Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study

Total Knee Arthroplasty Clinical Trial

Official title:

Safety and Performance of Journey II BCS Total Knee System. A Retrospective, Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292003
• Other study ID #: 16-4049-08
• Status: Completed
• Start date: December 30, 2016
• Est. completion date: September 24, 2018

Study information

• Verified date: March 2019
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this study is to estimate the safety and performance of Journey II BCS TKS.

Description:

The objective of this study is to estimate the safety and performance of Journey II BCS TKS. Specifically, the study will establish revision rate, treatment- and device-related complications, and clinical outcomes in a large sample of subjects who received the study device. Subjects are screened consecutively, beginning at the earliest date of implantation at each investigative site. Further, reasons for revision will be collected and analyzed. An analysis will be performed to identify characteristics (patient, surgeon and surgical) associated with an increased risk for revision. Finally, clinical, functional and quality of life outcomes will be analyzed to the extent data is available, given the retrospective study design.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Device:
• Journey II BCS Total Knee System

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Switzerland, 

Outcome

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