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Meniscus Implant
NUsurface Meniscus Implant for Osteoarthritis and Post-Meniscectomy Pain Syndrome (SUN Trial)
N/A
Waitlist Available
Research Sponsored by Active Implants
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 5 years
Awards & highlights
SUN Trial Summary
This trial is designed to test the safety and probable clinical benefit of the NUsurface® Meniscus Implant in patients who have had prior knee surgery.
Eligible Conditions
- Osteoarthritis
- Post-Meniscectomy Pain Syndrome
SUN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Clinical Performance
Safety assessed by Serious and non-serious, device-related and non-device related adverse events
SUN Trial Design
1Treatment groups
Experimental Treatment
Group I: NUsurface Meniscus ImplantExperimental Treatment1 Intervention
All eligible patients will receive the NUsurface® Meniscus Implant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NUsurface® Meniscus Implant
2014
N/A
~170
Find a Location
Who is running the clinical trial?
Active ImplantsLead Sponsor
5 Previous Clinical Trials
800 Total Patients Enrolled
3 Trials studying Osteoarthritis
661 Patients Enrolled for Osteoarthritis
Richard W Treharne, PhDStudy DirectorActive Implants LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The back part of your meniscus is completely torn.You have a medial meniscal rim that is at least 2 mm thick and can be fitted with a NUsurface® device.You have a knee problem caused by a tear that can be fixed with surgery, but there needs to be at least 4 mm of the rim of your medial meniscus left after the surgery.You have a knee that cannot bend properly and is stuck in a straight position.You have a condition where your knee cap is not aligned properly or is unstable, causing pain or discomfort.You have any kind of knee joint disease that causes inflammation, like Sjogren's syndrome.You cannot receive corticosteroid injections if you are allergic to any of its ingredients or have a condition called idiopathic thrombocytopenic purpura.You have received corticosteroid knee injections within the last three months before starting the study treatment.You have a knee deformity that causes your knee to bend inward or outward by more than 5 degrees, and you may need surgery to correct it.You have had a knee replacement surgery with a specific type of artificial knee implant made of non-resorbable materials like plastic, metal, or ceramic, except for the NUsurface® Meniscus Implant.You cannot bend your joint more than 90 degrees.You are currently smoking cigarettes.You have problems with your nerves that affect your senses, movement, or reflexes.You have a condition called neuropathic knee osteoarthropathy, also known as Charcot joint.You have a KOOS Pain of ≤ 75 (100 being the highest attainable and no pain).You have a body mass index (BMI) higher than 32.5 when you start the study treatment.You are considering getting a specific type of knee surgery called allograft medial meniscus transplantation.You had a surgery to fix your ACL (a ligament in your knee) less than 9 months ago.Your leg bones are straight when measured from the hip to the ankle.
Research Study Groups:
This trial has the following groups:- Group 1: NUsurface Meniscus Implant
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.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT02483988 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is the ideal candidate for this medical research project?
"This clinical trial seeks 115 patients aged between 30 and 75 years old, who suffer from knee osteoarthritis. The KOOS Pain score of the patient should not exceed 75 (100 being no pain) and they must have a neutral alignment ±5º of the mechanical axis, as measured by specific anatomical markers."
Answered by AI
Are participants still being accepted for this trial?
"The clinicaltrials.gov portal reveals that this medical trial, which was posted on the 1st of December 2015 and last updated on the 18th February 2022 is no longer recruiting candidates. However, there are 456 other studies actively enrolling participants at present."
Answered by AI
Does the age limit of seventy years or older disqualify individuals from participating in this investigation?
"According to the stipulations of this clinical trial, prospective participants must be between 30-75 years old. Additionally, there are 27 trials for minors and 433 specifically tailored towards elderly individuals."
Answered by AI
Who else is applying?
What state do they live in?
California
Oregon
Texas
Other
How old are they?
18 - 65
65+
What site did they apply to?
St Mary's Medical Center
Arlington Orthopedic Associates, PA
Long Beach Memorial Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
What questions have other patients asked about this trial?
How long do screen visits take? What is the recovery time for this surgery?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I have on and off knee swelling and pain after 2 surgeries in 2015 and 2020. Looking for long term remedy.
PatientReceived 2+ prior treatments
I had countless hours of physical therapy with little help. I had partial meniscus removal surgery. I also tried PRP and Steam Cells and that had little improvement.
PatientReceived 1 prior treatment
I have no meniscus remaining in my right knee. I am only 56 and do want a knee replacement yet. I had hyaluronan injections but they are wearing off, and the pain is returning. I have two children under the age of 6 and want to be active for them.
PatientReceived 2+ prior treatments
I have no meniscus remaining in my right knee. I am only 56 and do want a knee replacement yet. I had hyaluronic injections but they are wearing off, and the pain is returning. I have two children under the age of 6 and want to be active for them.
PatientReceived 2+ prior treatments
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