Completed

A Prospective, Multicenter Consecutive Series Study of Patients Treated With the Journey Deuce Bicompartmental Knee System

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Arthritis+2

+ Joint Diseases

+ Musculoskeletal Diseases

From 30 to 75 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Observational
Study Start: September 2006
See protocol details

Summary

Principal SponsorSmith & Nephew, Inc.
Last updated: October 11, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2006

Actual date on which the first participant was enrolled.

The objectives of this study are to assess the safety and effectiveness of the Journey Deuce Bicompartmental Knee System. Patients will be examined clinically at time intervals throughout the study duration. Exams will include completion of clinical assessment, x-rays, and completion of patient questionnaires.

NCT01704326
Principal SponsorSmith & Nephew, Inc.
Last updated: October 11, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

59 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 30 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteoarthritis

Criteria

4 inclusion criteria required to participate
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
Patient presents with non-inflammatory degenerative joint disease of the medial and patellofemoral compartments requiring a unilateral knee replacement
12 exclusion criteria prevent from participating
Patient has ACL deficiency in the study knee
Patient has BMI greater than or equal to 40
Patient has a known sensitivity to materials in the device
Patient has an active infection, local or systemic
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Orthopaedic Center of Vero Beach

Vero Beach, United StatesOpen Orthopaedic Center of Vero Beach in Google Maps

Orthopaedic Surgery Specialists, Ltd.

Park Ridge, United States

Henry County Center for Orthopedic Surgery & Sports Medicine

New Castle, United States

Iowa Orthopaedic Center, PC

Des Moines, United States
Completed4 Study Centers