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Orthopedic Implant
Monoblock for Osteoarthritis
N/A
Waitlist Available
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will compare the two types of tibia replacements in order to see which one performs better.
Eligible Conditions
- Osteoarthritis
- Joint Dislocation
- Polyarthritis
- Bow Legs or Knock Knees
- Rheumatoid Arthritis
- Osteonecrosis of the Femoral Condyle
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic Parameters
Secondary outcome measures
Oxford Knee Score
Revision Rate
Trial Design
2Treatment groups
Experimental Treatment
Group I: MonoblockExperimental Treatment1 Intervention
Subjects that receive the NexGen TM Monoblock Tibia
Group II: ModularExperimental Treatment1 Intervention
Subjects that receive the NexGen TM Modular Tibia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NexGen TM Monoblock Tibia
2017
N/A
~190
NexGen TM Modular Tibia
2017
N/A
~190
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Who is running the clinical trial?
Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,213 Total Patients Enrolled
129 Trials studying Osteoarthritis
32,942 Patients Enrolled for Osteoarthritis
Kacy Arnold, RN, MBAStudy DirectorZimmer Biomet
15 Previous Clinical Trials
3,820 Total Patients Enrolled
11 Trials studying Osteoarthritis
2,969 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called neuropathic arthropathy.You have weak bones, muscle loss, or a nerve disease that affects the strength of your limbs.You have an ongoing infection that could harm your artificial joint.You have rheumatoid arthritis with a skin ulcer or a history of frequent skin breakdowns.Your bones in your leg don't have enough strength or thickness.You are still growing and your bones have not fully developed.You have had a previous infection in the joint that is being studied.Your joint has been fused together in a stable and pain-free way, and it allows you to move normally.You have a known or suspected allergy or sensitivity to the materials used in the implant.Your ligaments are not strong enough to support stability in your joints.
Research Study Groups:
This trial has the following groups:- Group 1: Monoblock
- Group 2: Modular
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any research centers in North America conducting this study?
"This clinical trial has 7 total sites available for patients to enroll. Three of these locations are University of Pennsylvania in Philadelphia, Henry County Orthopedics and Sports Medicine in New Castle, and Pinehurst Surgical Clinic in Pinehurst; the remaining four centres have yet to be disclosed."
Answered by AI
Is this research endeavor taking on new participants?
"According to clinicaltrials.gov, this trial has already concluded its recruitment and is not accepting new participants at the moment; it was initially posted on October 3rd 2017 with a final update in April 11th 2023. Nevertheless, there are 1036 other studies that currently require volunteers for their research protocol."
Answered by AI
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