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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
No Placebo-Only Group
Summary
This trial is testing a new knee implant called the NUsurface® Meniscus Implant. It is designed for people with knee problems related to their meniscus. The implant works by acting as a cushion in the knee, helping to reduce pain and improve movement. NUsurface® prosthesis has been developed as a treatment option for patients experiencing persistent knee pain after medial meniscus surgery.
Eligible Conditions
- Osteoarthritis
- Post-Meniscectomy Pain Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Clinical Performance
Safety assessed by Serious and non-serious, device-related and non-device related adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
336 Total Patients Enrolled
3 Trials studying Osteoarthritis
197 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
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