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Prosthesis

Total Knee Arthroplasty for Osteoarthritis

N/A
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is a male or non-pregnant female and aged 50 to 75 years at the time of study device implantation
Participant is a candidate for a primary posterior-stabilized total knee replacement
Must not have
Participant has an active or suspected latent infection in or about the affected knee joint at time of study device implantation
Participant has a varus or valgus deformity greater than 15º or flexion contracture greater than 20º or knee flexion range of motion < 90º in either lower extremity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post-operative
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare three different types of knee replacements to see which is most effective in terms of movement, pain, and function.

Who is the study for?
This trial is for men and non-pregnant women aged 50-75 with Non-Inflammatory Degenerative Joint Disease needing knee replacement. They must be able to follow the study's procedures and have signed consent. Excluded are those with a BMI ≥ 40, recent or upcoming lower extremity surgeries, sensitivity to device materials, infections in the knee, or severe knee deformities.
What is being tested?
The study tests if Journey II knee implants lead to better outcomes than standard Stryker and Zimmer implants in terms of movement, walking patterns, pain relief, and function post-surgery.
What are the potential side effects?
While not specified here, typical side effects from knee replacement surgery can include pain at the site of operation, swelling around the knee joint area, stiffness in the operated leg or difficulty moving it.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 75 years old and not pregnant.
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I am a candidate for knee replacement surgery.
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I have been diagnosed with a type of arthritis that is not caused by inflammation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I might have an infection in or near my knee where a device will be implanted.
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My knee is severely bent or I can't straighten it fully.
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I need both knees replaced or had one knee partially/fully replaced recently.
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I need surgery to fix or replace my previous knee surgery.
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I haven't had or don't need leg surgery, except for knee replacement, in the next year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Knee
Max moment of knee flexion-extension during level treadmill walking
Knee
+3 more
Secondary study objectives
Cadence during level treadmill walking
Euro-Quality of Life five dimensions questionnaire (EQ-5D)
Forgotten Joint Score
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Journey IIExperimental Treatment1 Intervention
Smith and Nephew Richards (SNR) Journey II Knee prosthesis
Group II: ZimmerActive Control1 Intervention
Zimmer Persona® The Personalized Knee prosthesis
Group III: StrykerActive Control1 Intervention
Stryker Triathlon Total Knee prosthesis

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
937 Previous Clinical Trials
433,749 Total Patients Enrolled
11 Trials studying Osteoarthritis
907 Patients Enrolled for Osteoarthritis

Media Library

Journey II (Prosthesis) Clinical Trial Eligibility Overview. Trial Name: NCT03895489 — N/A
Osteoarthritis Research Study Groups: Zimmer, Stryker, Journey II
Osteoarthritis Clinical Trial 2023: Journey II Highlights & Side Effects. Trial Name: NCT03895489 — N/A
Journey II (Prosthesis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03895489 — N/A
~3 spots leftby Mar 2025
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