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

Anderson Orthopaedic Research Institute50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Arthroplasty

Interventions

Total Knee ReplacementDEVICE

Smith and Nephew Total Knee Replacement

DeuceDEVICE

Smith and Nephew Bicompartmental Knee Replacement

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Anderson Orthopaedic Research Institute

Alexandria, Virginia, United States

Outcomes

Primary Outcomes

2-Year Knee Society Score

Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.

Time frame: 2 years

6-Week Knee Society Score

Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.

Time frame: 6 weeks

4-Month Knee Society Score

Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.

Time frame: 4 months

1-year Knee Society Score

Knee Society Clinical Rating System (KSS) provides for separate knee pain and patient functional assessment scores. Scale of 0-100 with higher values representing a better score.

Time frame: 1 year

Secondary Outcomes

6-Week X-rays

Knee Society Roentgenographic Evaluation and Scoring System will assess alignment; any evidence of loosening as indicated primarily by radiolucencies \> 2mm; evidence of surface wear or particulate debris generation as indicated by early osteolysis, implant migration, or other clinical or radiographic abnormalities. Number of participants with these radiographic abnormalities by X-ray at 6 weeks are reported.

Time frame: 6 weeks

4-month X-rays

Data from ClinicalTrials.gov

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