A Prospective, Multicenter Consecutive Series Study of Patients Treated With the Journey Deuce Bicompartmental Knee System

Smith & Nephew, Inc.4 sites in 1 country59 target enrollmentSeptember 2006

ConditionsOsteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Smith & Nephew, Inc.
Enrollment: 59
Locations: 4
Primary Endpoint: Change in Knee Society Score
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

May 2012

Last Updated

13 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Smith & Nephew, Inc.

Responsible Party

Sponsor

Eligibility 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
•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.

Outcomes

Primary Outcomes

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 Outcomes

Patient Satisfaction(6 weeks, 3 months, 6 months, 1 year and 2 years)
Oxford Knee Outcome Questionnaire(Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years)
Radiographic Evaluation(6 weeks, 1 year and 2 years)
Adverse Events(When Necessary)