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

Knee Arthroplasty Clinical Trial

— Deuce  

Official title:

A Prospective, Single-Center, Randomized Study Comparing the Functional Performance of the Journey Deuce Bicompartmental With the Genesis II Total Knee System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140815
• Other study ID #: AORI2010-0103
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2010
• Last updated: July 10, 2014
• Start date: September 2007
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: Anderson Orthopaedic Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Device:
• Total Knee Replacement
Smith and Nephew Total Knee Replacement
• Deuce
Smith and Nephew Bicompartmental Knee Replacement

Locations

Country	Name	City	State
United States	Anderson Orthopaedic Research Institute	Alexandria	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Anderson Orthopaedic Research Institute	Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	No
Primary	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.	6 weeks	No
Primary	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.	4 months	No
Primary	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.	1 year	No
Secondary	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.	6 weeks	No
Secondary	4-month 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 4 months are reported.	4 months	No
Secondary	1-year 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 1 year are reported.	1 year	No
Secondary	2-year 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 2 years are reported.	2 years	No
Secondary	2-year Patient Surveys	Serial patient evaluation of function will be assessed using the Oxford Knee Outcome Questionnaire. The Oxford Questionnaire consists of 12 questions, each with a value of 0 (bad) to 4(good). The results are summed for a total score of 0(bad) to 48(good).	2 years	No
Secondary	6-week Functional Testing	A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.	6 weeks	No
Secondary	4-month Functional Testing	A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.	4 months	No
Secondary	1-year Functional Testing	A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.	1 year	No
Secondary	2-year Functional Testing	A timed Functional Assessment Test, gait analysis, and balance testing for lower extremity motor function will be performed. Fewer seconds in the result indicates faster performance, which is a positive result.	2 years	No