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Implant
Agili-C™ Implant for Knee Joint Problems
N/A
Waitlist Available
Led By Elizaveta Kon, MD
Research Sponsored by Cartiheal (2009) Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 21-75 years
Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative until 2 years postoperatively
Awards & highlights
Study Summary
This trial compares the effectiveness and safety of a new implant to the current standard surgical treatment for patients with different kinds of problems affecting the surface of the knee joint.
Who is the study for?
This trial is for adults aged 21-75 with knee joint surface lesions or mild to moderate osteoarthritis, who haven't improved with physical therapy. Participants must be able to follow post-op rehab and attend check-ups. Exclusions include severe systemic diseases, certain medications, extreme pain levels, deep bony defects, other knee cartilage issues, obesity (BMI > 35), recent chemo or surgery in the affected knee.Check my eligibility
What is being tested?
The study compares the Agili-C implant's effectiveness and safety against standard surgical care for various knee joint surface lesions. It includes patients with focal cartilage damage or early-stage osteoarthritis and assesses how well they recover after treatment.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include typical surgical complications such as infection risk at the implant site, inflammation around the area of surgery, allergic reactions to implant materials like calcium carbonate or hyaluronate.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 75 years old.
Select...
I have painful skin areas totaling 1-7 cm2.
Select...
I have up to 3 severe knee joint surface lesions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ preoperative until 2 years postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative until 2 years postoperatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
KOOS Score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Agili-CExperimental Treatment1 Intervention
Group II: Surgical Standard of Care (SSOC)Active Control1 Intervention
Find a Location
Who is running the clinical trial?
Cartiheal (2009) LtdLead Sponsor
3 Previous Clinical Trials
228 Total Patients Enrolled
Elizaveta Kon, MDPrincipal InvestigatorIstituto Clinico Humanitas, Via A. Manzoni 56, Rozzano, Milano, Italy
9 Previous Clinical Trials
809 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes and need insulin.I have a history of joint inflammation or crystal buildup in my joints.I had a meniscal transplant within the last 6 months.I have a tumor in my knee.I have had an infection in my knee joint or bone.I don't have any active infections, or I had a UTI but it's cleared now.My knee's cushioning is mostly gone, but a small part remains.I am on blood thinners, but I take 100 mg or less of aspirin daily.I am between 21 and 75 years old.My bone defect is deeper than 8mm as shown by an MRI, X-ray, or arthroscopy.My knee cartilage damage is severe (grade IVa or higher).My knee is significantly unstable, rated as abnormal or severely abnormal.I have not had knee surgery for cartilage issues in the last 6 months.My lesion is not fully enclosed by a thick bone wall.I do not have any known bone or cartilage disorders like osteoporosis.I have had surgery on my knee for ligament repair or alignment in the last 6 months.I do not have a history of significant diseases like HIV or hepatitis.I have had a steroid injection into a joint in the last month.I am between 21 and 75 years old.Physical therapy hasn't improved my condition in 3-4 weeks.My knee arthritis is severe, as per the Kellgren-Lawrence scale.I have not had chemotherapy in the last 12 months.My knee bends inward or outward more than 8 degrees.My knee pain score is either below 20 or above 65.I have painful skin areas totaling 1-7 cm2.I have up to 3 severe knee joint surface lesions.
Research Study Groups:
This trial has the following groups:- Group 1: Agili-C
- Group 2: Surgical Standard of Care (SSOC)
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.
Is senior participation invited in this clinical trial?
"This clinical trial seeks out individuals aged 21 to 75 years old."
Answered by AI
Could I potentially gain access to this clinical trial?
"Eligibility requirements for this research trial specify that participants must have arthrosis and be aged between 21 and 75. The study is looking to recruit 251 individuals in total."
Answered by AI
In how many geographic areas is this research being conducted?
"Ohio State University, Wexner Medical Center in Columbus, Horizon Clinical Research in San Diego, and LSU Healthcare Network Orthopedic & Sports Medicine in New Orleans are just some of the 11 operating medical centres for this trial. Additional sites can be found across the United States."
Answered by AI
Is enrollment for this study still an option?
"The information hosted on clinicaltrials.gov indicates that this particular medical study is not currently accepting new candidates. Originally posted on September 25th 2017 and last updated July 14th 2022, the trial has discontinued its recruitment process for now; however, 614 other studies are actively seeking participants at this time."
Answered by AI
Who else is applying?
What state do they live in?
California
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Horizon Clinical Research
Oregon Health & Science University
Other
NYU Langone Orthopedic Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
Because of my right knee.
PatientReceived 2+ prior treatments
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