Clinical trial NCT01704326: A Study of Patients Treated With the Journey Deuce Bicompartmental Knee System
Official title: A Prospective, Multicenter Consecutive Series Study of Patients Treated With the Journey Deuce Bicompartmental Knee System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Deuce
Journey Deuce
Knee pain
Osteoarthritis
Bicompartmental
Femoral
Medial
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-11
Enrollment: 59
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Change in Knee Society Score
timeFrame: Preoperative-2 years
Secondary outcomes:
measure: Oxford Knee Outcome Questionnaire
timeFrame: Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years
measure: Radiographic Evaluation
timeFrame: 6 weeks, 1 year and 2 years
measure: Patient Satisfaction
timeFrame: 6 weeks, 3 months, 6 months, 1 year and 2 years
measure: Adverse Events
timeFrame: When Necessary
Other outcomes:
Locations:
city: Vero Beach
country: United States
facility: Orthopaedic Center of Vero Beach
state: Florida
city: Park Ridge
country: United States
facility: Orthopaedic Surgery Specialists, Ltd.
state: Illinois
city: New Castle
country: United States
facility: Henry County Center for Orthopedic Surgery & Sports Medicine
state: Indiana
city: Des Moines
country: United States
facility: Iowa Orthopaedic Center, PC
state: Iowa
Study officials:
References: