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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
Must not have
Subject has a diagnosis of avascular necrosis or inflammatory arthritis
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
No Placebo-Only Group
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.
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.
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 belowSelect...
I am a man or a non-pregnant woman aged 18 to 75.
Select...
I am a man or a non-pregnant woman aged 18 to 75.
Select...
I am approved for a total knee replacement using specific knee implants.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with avascular necrosis or inflammatory arthritis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ operative visit; post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Active and Passive Range of Motion
Change in Anterior/Posterior Knee Translation
Change in Five Times Sit to Stand Test
+7 moreSecondary study objectives
Change in Forgotten Joint Score FJS
Knee
Knee
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
30 Previous Clinical Trials
4,400 Total Patients Enrolled
3 Trials studying Osteoarthritis
591 Patients Enrolled for Osteoarthritis
Rubin Institute for Advanced OrthopedicsUNKNOWN
1 Previous Clinical Trials
78 Total Patients Enrolled
James Nace, MDPrincipal InvestigatorLifeBridge Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a prosthetic device on the operative knee.I can walk and have no issues with my other limb that would affect walking tests.I can attend all required study visits and follow the study plan.You have a mental or neuromuscular condition that could make it risky for you to have surgery or could cause problems with the artificial body part after the surgery.I am a man or a non-pregnant woman aged 18 to 75.I am a man or a non-pregnant woman aged 18 to 75.I am approved for a total knee replacement using specific knee implants.I can walk and have no issues with my other leg that would affect walking tests.I can follow the study schedule and return for all needed visits.I have been diagnosed with avascular necrosis or inflammatory arthritis.
Research Study Groups:
This trial has the following groups:- Group 1: Single Radius Design Total Knee System
- Group 2: Medial-Pivot Knee System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.