Safety and Efficacy of the Journey II BCS Total Knee System

Osteoarthritis, Knee Clinical Trial

— NIMBLE  

Official title:

A Retro-Prospective, Non-randomized, Consecutive Series, SIngle Cohort, Multicenter Adaptive Design Study to Evaluate the Outcomes of Total Knee Arthroplasty (TKA) Using JOURNEY™ II BCS TotaL Knee SystEm (The NIMBLE Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705067
• Other study ID #: 2011JBCK151
• Status: Completed
• Start date: June 2012
• Est. completion date: July 31, 2023

Study information

• Verified date: June 2024
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.

Description:

Assess the safety and efficacy of the JOURNEY II BCS Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement. Pre-operative and operative assessments collected retrospectively. All postoperative assessments beginning at the 6 month post-operative time point collected prospectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subject received primary total knee arthroplasty with the JOURNEY™ II BCS Total Knee System due to degenerative joint disease

• Subject is willing to sign and date an IRB approved consent form

• Subject is of legal age to consent

• Subject plans to be available through ten (10) years postoperative follow-up

• Subject agrees to follow the study protocol

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

• Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty

• Subject possesses a contralateral or ipsilateral revision hip arthroplasty

• Subject has ipsilateral hip arthritis resulting in flexion contracture

• At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator:

• Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty

• Contralateral primary total knee or unicondylar knee arthroplasty

• At the time of surgery, subject had an active infection or sepsis (treated or untreated)

• At the time of surgery, subject had presence of malignant tumor, metastatic, or neoplastic disease

• At the time of surgery, subject had conditions that may interfere with the TKA survival or outcome (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)

• At the time of surgery, subject had contralateral lower extremity condition causing abnormal ambulation

• Subject is pregnant or plans to become pregnant during the study

• Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study

• At the time of surgery, subject had a BMI>40

• At the time of enrollment, subject has a BMI>40

• Subject is enrolled in another investigational drug, biologic, or device study

• Subject is facing current or impending incarceration

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• TKA with Journey II BCS Total Knee System
TKA with Journey II BCS Total Knee System

Locations

Country	Name	City	State
United States	OrthoCarolina	Charlotte	North Carolina
United States	Cincinnati Orthopaedic Research Institute	Cincinnati	Ohio
United States	Wellington Orthopaedics	Cincinnati	Ohio
United States	Minimally Invasive Orthopaedics	Columbus	Ohio
United States	Fort Wayne Orthopedics	Fort Wayne	Indiana
United States	Methodist Sports Medicine/The Orthopedic Specialist	Indianapolis	Indiana
United States	Evergreen Orthopaedic Clinic	Kirkland	Washington
United States	Tennessee Orthopaedic Clinics	Knoxville	Tennessee
United States	Joint Replacement Institute at St. Vincent Medical Center	Los Angeles	California
United States	Hospital for Special Surgery	New York	New York
United States	San Antonio Orthopaedic Specialists	San Antonio	Texas
United States	Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ITB Friction Pain		6 months post-operatively
Secondary	Adverse Events		6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
Secondary	Radiographic Evaluation		Baseline and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively
Secondary	Knee Society Score		6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively