Overview

This trial is active, not recruiting.

Condition knee arthroplasty
Treatments total knee replacement, deuce
Phase phase 4
Sponsor Anderson Orthopaedic Research Institute
Collaborator Smith & Nephew, Inc.
Start date September 2007
End date December 2012
Trial size 50 participants
Trial identifier NCT01140815, AORI2010-0103

Summary

The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System at 4-6 weeks, 4 months, 1 year, and 2 years when compared to total knee replacement using the Genesis II Total Knee System. The hypothesis is that the Journey Deuce Bicompartmental Knee System is as safe and effective as the Genesis II Total Knee System at the 2-year. The null hypothesis is that there is no difference between the groups.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
The Smith and Nephew Total Knee System
total knee replacement
Smith and Nephew Total Knee Replacement
(Experimental)
The Journey Deuce Bicompartmental Knee System
deuce
Smith and Nephew Bicompartmental Knee Replacement

Primary Outcomes

Measure
2-Year Knee Society Score
time frame: 2 years
6-Week Knee Society Score
time frame: 6 weeks
4-Month Knee Society Score
time frame: 4 months
1-year Knee Society Score
time frame: 1 year

Secondary Outcomes

Measure
6-Week x-rays
time frame: 6 weeks
4-month X-rays
time frame: 4 months
1-year x-rays
time frame: 1 year
2-year X-rays
time frame: 2 years
6-week Patient Surveys
time frame: 6 weeks
4-month Patient Surveys
time frame: 4 months
1-year Patient Surveys
time frame: 1 year
2-year Patient Surveys
time frame: 2 years
6-week Functional Testing
time frame: 6 weeks
4-month Functional Testing
time frame: 4 months
1-year Functional Testing
time frame: 1 year
2-year Functional Testing
time frame: 2 years

Eligibility Criteria

Male or female participants from 30 years up to 65 years old.

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 65 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 2 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 > 35. - 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 follow-up (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 is on workman's compensation. - Patient has a known sensitivity to materials in the device.

Additional Information

Official title A Prospective, Single-Center, Randomized Study Comparing the Functional Performance of the Journey Deuce Bicompartmental With the Genesis II Total Knee System
Principal investigator Gerard A. Engh, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Anderson Orthopaedic Research Institute.