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A Study of Patients Treated With the Journey Deuce Bicompartmental Knee System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01704326
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee System and is intended to evaluate the safety and effectiveness of the new device.

Condition or disease
Osteoarthritis

Detailed Description:
The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System. Patients will be examined clinically at time intervals throughout the study duration. Exams will include completion of clinical assessment, x-rays, and completion of patient questionnaires.

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Study Type : Observational
Actual Enrollment : 59 participants
Time Perspective: Prospective
Official Title: A Prospective, Multicenter Consecutive Series Study of Patients Treated With the Journey Deuce Bicompartmental Knee System
Study Start Date : September 2006
Actual Primary Completion Date : February 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in Knee Society Score [ Time Frame: Preoperative-2 years ]
    Assess knee pain, function and range of motion using the Knee Society Clinical Rating System


Secondary Outcome Measures :
  1. Oxford Knee Outcome Questionnaire [ Time Frame: Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years ]
    Patient evaluation of function

  2. Radiographic Evaluation [ Time Frame: 6 weeks, 1 year and 2 years ]
    X-rays will be assessed for evidence of implant loosening, surface wear, migration or any other clinical or radiographic abnormalities.

  3. Patient Satisfaction [ Time Frame: 6 weeks, 3 months, 6 months, 1 year and 2 years ]
    Patient satisfaction questionnaire to be completed at each follow-up visit

  4. Adverse Events [ Time Frame: When Necessary ]
    All intra-operative, discharge, and post-operative surgical/hospitalization or study knee-related adverse events will be captured during the study to assess for safety issues.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The patients eligible for this study are non-inflammatory degenerative joint disease patients requiring a primary unilateral knee surgery. The affected areas must be limited to the medial and patellofemoral compartments.
Criteria

Inclusion Criteria:

  • Patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement.
  • Patient is 30 to 75 years of age, inclusive.
  • Patient is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
  • Patient plans to be available for follow-up through five years postoperative.

Exclusion Criteria:

  • Patient is known to have insufficient femoral or tibial bone stock resulting from conditions such as cancer, distal femoral/proximal tibial osteotomy, significant osteoporosis or metabolic bone disorders.
  • Patient is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder (i.e. chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli.) Examples of such conditions include patients who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or patients with acquired immunodeficiency syndrome (AIDS).
  • Patient has inflammatory arthritis (e.g. rheumatoid arthritis)
  • Patient has BMI greater than or equal to 40.
  • Patient has had major knee surgery in the past i.e. HTO, unicondylar knee replacement, failed fracture fixation.
  • Patient has an active infection, local or systemic.
  • Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and followup (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple sclerosis, etc.).
  • Patient has ACL deficiency in the study knee.
  • Patient has hip arthritis and/or replacement.
  • Patient has lateral compartment disease.
  • Patient is pregnant or plans to become pregnant during the course of the study.
  • Patient has a known sensitivity to materials in the device.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704326


Locations
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United States, Florida
Orthopaedic Center of Vero Beach
Vero Beach, Florida, United States, 32860
United States, Illinois
Orthopaedic Surgery Specialists, Ltd.
Park Ridge, Illinois, United States, 60068
United States, Indiana
Henry County Center for Orthopedic Surgery & Sports Medicine
New Castle, Indiana, United States, 47362
United States, Iowa
Iowa Orthopaedic Center, PC
Des Moines, Iowa, United States, 50314
Sponsors and Collaborators
Smith & Nephew, Inc.
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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT01704326    
Other Study ID Numbers: DEUK01
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012
Keywords provided by Smith & Nephew, Inc.:
Deuce
Journey Deuce
Knee pain
Osteoarthritis
Bicompartmental
Femoral
Medial
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases