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Completed

NCT Number: NCT01705067

Safety and Efficacy of the Journey II BCS Total Knee System

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Joint Replacement Institute at St. Vincent Medical Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TKA with Journey II BCS Total Knee System

Device

TKA with Journey II BCS Total Knee System

Other names: Journey II BCS

Primary outcomes

  1. Rate of ITB Friction Pain

    Time frame: 6 months post-operatively

Secondary outcomes

  1. Adverse Events

    Time frame: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively

  2. Radiographic Evaluation

    Time frame: Baseline and 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively

  3. Knee Society Score

    Time frame: 6 months post-operatively, 1 year post-operatively, 2 years post-operatively, 5 years post-operatively, and 10 years post-operatively

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Official study 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)

Acronym: NIMBLE

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2012
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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