JOURNEY„¢ II CR Total Knee System

Description

The purpose of this study is to evaluate the safety and effectiveness of the JOURNEY™ II CR Total Knee System in subjects with degenerative joint disease (DJD) requiring primary total knee replacement.

Study Start Date

September 2015

Estimated Completion Date

February 2027

Interventions

  • Device: JOURNEY™ II CR Total Knee System (J II CR TKS)
  • Device: JOURNEYâ„¢ II CR Total Knee System (J II CR TKS)

Specialties

  • Family Medicine: Orthopedic/Physical Med
  • Rheumatology: Osteoarthritis
  • Orthopedics: Arthritis/Rheumatology,Knee,Surgical Technique

MeSH Terms

  • Arthritis
  • Osteoarthritis
  • Osteoarthritis, Knee

Study ID

Smith & Nephew, Inc. -- 13-4049-06

Status

Recruiting

Trial ID

NCT02440672

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

170

Sponsor

Smith & Nephew, Inc.

Inclusion Criteria

    Subjects MUST meet ALL of the following criteria for inclusion in the study:
  • Has signed the IRB/EC approved ICF specific to this study prior to study participation
  • Is a male or female ? 22 and ? 75 years of age presenting with degenerative joint disease (DJD) of the knee
  • Is a candidate for primary total knee arthroplasty with the JOURNEY™ II CR Total Knee System due to DJD, defined by one of the following:
  • Post-traumatic arthritis
  • Osteoarthritis
  • Degenerative arthritis
  • Is able to read and understand the approved Informed Consent Form and Patient Reported Outcome (PRO) assessments (written and oral)
  • Is in general good health (as determined by the Investigator) based on screening assessments and medical history
  • Is independent, ambulatory, and can comply with all post-operative evaluations
  • plans to be available through ten (10) years post-operative follow-up

Exclusion Criteria

  • Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
  • Any of the following conditions in the index joint:
  • does not require patella resurfacing
  • has received a TKA or unicondylar arthroplasty
  • has inadequate bone stock to support the device (e.g. severe osteopenia/osteoporosis)
  • Any of the following conditions in the contralateral joint:
  • has enrolled in the study for the contralateral knee
  • has received TKA as a revision for a failed total or unicondylar knee arthroplasty
  • has received a primary TKA or unicondylar knee arthroplasty that is not fully healed and well-functioning, as determined by Investigator
  • Any of the following conditions of the hip:
  • received contralateral or ipsilateral revision hip arthroplasty
  • has ipsilateral hip arthritis resulting in flexion contracture
  • has received a ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty, that is not fully healed and well-functioning, as determined by Investigator
  • Has diagnosis of an immunosuppressive disorder
  • Has presence of malignant tumor, metastatic, or neoplastic disease
  • Has family history of severe osteoporosis/osteopenia
  • Has a known allergy to study device or one or more of its components
  • Has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
  • Is receiving medication for the diagnosis of fibromyalgia
  • has a lower extremity condition causing abnormal or restricted ambulation (e.g. ankle fusion, ankle arthroplasty, previous hip fracture)
  • Is pregnant or plans to become pregnant during the study
  • Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study and complete PROs, as determined by Investigator
  • Has a BMI>40
  • Is currently enrolled in or has participated in another investigational drug, biologic, or device study within 3 months of enrollment
  • Is currently involved in personal injury litigation or a worker's compensation claim
  • Is facing current or impending incarceration
  • Is known to be at risk for lost to follow-up, or failure to return for scheduled visits

Gender

Both

Ages

22 Years to 75 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (8)

Study Location Distance Name Phone Email
Columbia University Medical Center - New York, New York 44.8 miles Taylor Murtaugh 212-305-8193 tm2750@cumc.columbia.edu
Hospital for Special Surgery - New York, New York 48.5 miles None None None
Anne Arundel Health System Research Institute Inc - Annapolis, Maryland 230.8 miles None None None
Wake Forest University - Winston-Salem, North Carolina 523.1 miles Martha B Holden 336-716-5457 mholden@wakehealth.edu
The Carl and Edith Lindner Center for Research and Education at the Christ Hospital - Cincinnati, Ohio 613.2 miles Nancy Halsey 513-585-1783 nancy.halsey@thechristhospital.com
The Christ Hospital - Cincinnati, Ohio 613.2 miles Nancy Halsey 513-585-1783 nancy.halsey@thechristhospital.com
Rush University Medical Center - Chicago, Illinois 748.9 miles Katherine Roeder RN 312-432-2461 katherine.roeder@rushortho.com
Hedley Orthopaedic Institute - Phoenix, Arizona 2,181.7 miles Leigh Breslauer 602-318-5716 lbreslauer@cox.net

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