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Orthopedic Implant

Knee Replacement Systems for Osteoarthritis

N/A
Recruiting
Led By James Nace, MD
Research Sponsored by LifeBridge Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is male or non-pregnant female aged between 18 and 75 years of age.
Subject is male or non-pregnant female aged between 18 and 75 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operative; post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
Awards & highlights

Study Summary

This trial is comparing two types of knee replacements to see which works better for patients with degenerative joint disease.

Who is the study for?
This trial is for men and non-pregnant women aged 18-75 who need a knee replacement due to degenerative joint disease. They must be able to walk, attend follow-up visits, and not have had previous knee replacements or conditions that would affect walking tests.Check my eligibility
What is being tested?
The study compares two types of knee implants: the MicroPort Evolution Medial-Pivot Knee System and the Stryker Triathlon Tritanium Knee System. It will assess which design better improves pain relief, function, and patient satisfaction after surgery.See study design
What are the potential side effects?
Potential side effects from total knee replacement may include pain at the surgery site, swelling, stiffness in the knee joint, infection risk at the wound site or within the new joint.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man or a non-pregnant woman aged 18 to 75.
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I am a man or a non-pregnant woman aged 18 to 75.
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I am approved for a total knee replacement using specific knee implants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~operative visit; post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and operative visit; post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Active and Passive Range of Motion
Change in Anterior/Posterior Knee Translation
Change in Five Times Sit to Stand Test
+7 more
Secondary outcome measures
Change in Forgotten Joint Score FJS
Knee
Knee
+4 more

Trial Design

2Treatment groups
Active Control
Group I: Single Radius Design Total Knee SystemActive Control1 Intervention
Total Knee Arthroplasty will be done by implanting the Stryker Triathlon Tritanium Knee System into subjects.
Group II: Medial-Pivot Knee SystemActive Control1 Intervention
Total Knee Arthroplasty will be done by implanting the MicroPort Medial Pivot Knee System into subjects.

Find a Location

Who is running the clinical trial?

MicroPort Orthopedics Inc.Industry Sponsor
31 Previous Clinical Trials
3,386 Total Patients Enrolled
7 Trials studying Osteoarthritis
592 Patients Enrolled for Osteoarthritis
LifeBridge HealthLead Sponsor
28 Previous Clinical Trials
4,268 Total Patients Enrolled
2 Trials studying Osteoarthritis
539 Patients Enrolled for Osteoarthritis
Rubin Institute for Advanced OrthopedicsUNKNOWN
1 Previous Clinical Trials
78 Total Patients Enrolled

Media Library

MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting) (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04814082 — N/A
Osteoarthritis Research Study Groups: Single Radius Design Total Knee System, Medial-Pivot Knee System
Osteoarthritis Clinical Trial 2023: MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting) Highlights & Side Effects. Trial Name: NCT04814082 — N/A
MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting) (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04814082 — N/A

Frequently Asked Questions

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

Is enrollment still open for participation in this experiment?

"Affirmative. Clinicaltrials.gov hosts data that demonstrates this medical research is currently enrolling candidates, which started in February 2021 and was recently modified on April 14th 2022. It requires a total of 100 patients from one site to take part."

Answered by AI

How many individuals have participated in this experiment to date?

"Affirmative. Clinicaltrials.gov has the data to show that this clinical trial, first posted on February 1st 2021, is currently enrolling patients. Approximately 100 individuals need be recruited from a single medical facility."

Answered by AI

Who is eligible to be part of this clinical trial?

"This trial is enrolling a hundred osteoarthritis patients aged 18 to 75 and with knee involvement. In addition, potential participants must satisfy the following conditions: no prosthetic device on the operative knee; male or non-pregnant female; able and willing to adhere to study schedule and return for follow-up visits; ambulating without any contralateral limb condition interfering with gait laboratory evaluations."

Answered by AI

What are the essential goals of this investigation?

"MicroPort Orthopedics Inc., the clinical trial sponsor, has reported that Change in Initial Peak Loading Force will be their primary outcome measure over a Pre-operative; Post-operative - 3 month and 12 month follow-up visit interval. Secondary outcomes include change in Patient Reported Outcomes Measurement Information System (PROMIS-10) which is assessed with 10 items on a 1 to 5 scale resulting in Global Physical Health Score and Global Mental health score plus T-score comparison with general population, Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) comprising 42 questions ranging from 0 to 100 where higher"

Answered by AI

Does this research protocol allow for enrollment of octogenarians?

"This medical trial requires patients to be between the ages of 18 and 75 years old. Furthermore, 47 separate studies are available for minors below 18 while people over 65 can choose from 750 different trials."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Maryland
How old are they?
65+
What site did they apply to?
Sinai Hospital of Baltimore
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Sinai Hospital of Baltimore: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
2021. "Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04814082.
All > Osteoarthritis Knee
~24 spots leftby Apr 2025
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