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

NCT01140815 | Completed Phase 4 Results DMC

• 1 other identifier: AORI2010-0103
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Total Knee Arthroplasty; Bicompartmental Knee Arthroplasty

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (9)

• 6-Week X-rays

  6 weeks

• 4-month X-rays

  4 months

• 1-year X-rays

  1 year

• 2-year X-rays

  2 years

• 2-year Patient Surveys

  2 years

Study Arms (2)

Total

ACTIVE COMPARATOR

The Smith and Nephew Total Knee System

Device: Total Knee Replacement

Deuce

EXPERIMENTAL

The Journey Deuce Bicompartmental Knee System

Device: Deuce

Interventions

Total Knee Replacement DEVICE

Smith and Nephew Total Knee Replacement

Total

Deuce DEVICE

Smith and Nephew Bicompartmental Knee Replacement

Deuce

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anderson Orthopaedic Research Institute: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22307, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Knee Research Director
• Organization: AORI

nancylparks@gmail.com

7036194423

Study Officials

• Gerard A. Engh, MD

  AORI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Knee Project Director

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 10, 2010
• Study Start: September 1, 2007
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 4, 2014
• Results First Posted: August 4, 2014

Record last verified: 2014-07

Locations

US (1)