Functional Performance of the Journey Deuce Bicompartmental Versus the Genesis II Total Knee System

NCT ID: NCT01140815

Last Updated: 2014-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2013-05-31

Brief 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.

Conditions

Knee Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Total

The Smith and Nephew Total Knee System

Group Type: ACTIVE_COMPARATOR

Total Knee Replacement

Intervention Type: DEVICE

Smith and Nephew Total Knee Replacement

Deuce

The Journey Deuce Bicompartmental Knee System

Group Type: EXPERIMENTAL

Deuce

Intervention Type: DEVICE

Smith and Nephew Bicompartmental Knee Replacement

Interventions

Total Knee Replacement

Smith and Nephew Total Knee Replacement

Intervention Type: DEVICE

Deuce

Smith and Nephew Bicompartmental Knee Replacement

Intervention Type: DEVICE

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 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: collaborator

Anderson Orthopaedic Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Nancy Parks

Knee Project Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerard A. Engh, MD

Role: PRINCIPAL_INVESTIGATOR

AORI

Locations

Anderson Orthopaedic Research Institute

Alexandria, Virginia, United States

Countries

United States

Other Identifiers

AORI2010-0103

Identifier Type: -

Identifier Source: org_study_id