NCT01704326

Brief Summary

This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee System and is intended to evaluate the safety and effectiveness of the new device.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

5.4 years

First QC Date

September 24, 2012

Last Update Submit

October 9, 2012

Conditions

Osteoarthritis

Keywords

DeuceJourney DeuceKnee painOsteoarthritisBicompartmentalFemoralMedial

Outcome Measures

Primary Outcomes (1)

  • Change in Knee Society Score

    Assess knee pain, function and range of motion using the Knee Society Clinical Rating System

    Preoperative-2 years

Secondary Outcomes (4)

  • Oxford Knee Outcome Questionnaire

    Preoperative, 6 weeks, 3 months, 6 months, 1 year and 2 years

  • Radiographic Evaluation

    6 weeks, 1 year and 2 years

  • Patient Satisfaction

    6 weeks, 3 months, 6 months, 1 year and 2 years

  • Adverse Events

    When Necessary

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients eligible for this study are non-inflammatory degenerative joint disease patients requiring a primary unilateral knee surgery. The affected areas must be limited to the medial and patellofemoral compartments.

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 75 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 five 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 greater than or equal to 40.
  • 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 followup (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 has a known sensitivity to materials in the device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Orthopaedic Center of Vero Beach

Vero Beach, Florida, 32860, United States

Location

Orthopaedic Surgery Specialists, Ltd.

Park Ridge, Illinois, 60068, United States

Location

Henry County Center for Orthopedic Surgery & Sports Medicine

New Castle, Indiana, 47362, United States

Location

Iowa Orthopaedic Center, PC

Des Moines, Iowa, 50314, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2012

First Posted

October 11, 2012

Study Start

September 1, 2006

Primary Completion

February 1, 2012

Study Completion

May 1, 2012

Last Updated

October 11, 2012

Record last verified: 2012-10

Locations

US(4)