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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post-operative
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
889 Previous Clinical Trials
385,059 Total Patients Enrolled
10 Trials studying Osteoarthritis
782 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor presently searching for new participants?

"According to clinicaltrials.gov, this medical study has opened up recruitment for participants and was first published on the 9th of September in 2019. It has received its most recent update on August 11th 2022."

Answered by AI

How many volunteers are being recruited for this medical trial?

"Affirmative. According to clinicaltrials.gov, this research is actively recruiting patients since it was first posted in September 2019 and then updated last August 2022. There are 60 positions open at a single medical centre."

Answered by AI

Is it possible for me to participate in this experiment?

"This clinical trial is searching for 60 people between the ages of 50 to 75 who have osteoarthritis, knee. To be included in this study they must adhere to several conditions including: being a potential candidate for posterior-stabilized total knee replacement surgery, giving signed approval via an informed consent form, not being pregnant or male aged over 50 and under 75 years old at time of implantation procedure, having been diagnosed with Non Inflammatory Degenerative Joint Disease (NIDJD), and demonstrating commitment towards postoperative evaluations and rehabilitation sessions."

Answered by AI

Does this clinical experiment have an upper age limit for participants?

"The eligibility requirements for this medical trial specify that all candidates must be in between the ages of 50 and 75."

Answered by AI

What is the ultimate aim of this research endeavor?

"Over the course of one year post-operation, primary outcomes will be measured in terms of max velocity of knee abduction-adduction during level treadmill walking. Secondary measurements include walking velocities (as m/s) through a Computer Assisted Rehabilitation Environment (CAREN), The Knee Society Clinical Rating Scores, and UCLA activity-level rating scores ranging from 1 to 10."

Answered by AI
~1 spots leftby Jun 2024