FibroFix Cartilage P Knee Implant Study (NCT05560490) | Clinical Trial Compass
TerminatedNot Applicable
FibroFix Cartilage P Knee Implant Study
Stopped: Safety issues
Hungary, United Kingdom2 participantsStarted 2022-10-20
Plain-language summary
This is a multi-center first-in-human prospective clinical investigation to evaluate the safety and performance of the FibroFix™ Cartilage P Implant and Drill Set. The Implant is a medical device designed by Orthox Ltd. to repair a damaged area of cartilage within the knee joint.
The aim is to 75 participants over two Stages:
In STAGE I, up to a total of 6 subjects will be recruited and safety assessed after 6 months of follow-up.
In Stage II an additional 69 subjects. The subjects will be followed up for 2 years with MRI imaging, then a further 8 years with patient outcome questionnaires.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient is able to provide written informed consent;
. Age ≥18 years at time of enrolment;
. Able to comply with the protocol-defined pre-operative procedures, the post-operative clinical and imaging evaluations and the recommended rehabilitation regimen as determined by the Investigator;
. Has a joint surface lesion, ICRS Grade 3 or above, on femoral condyles;
. Female subjects of child-bearing potential: a negative urine pregnancy test at time of enrolment.
. Patient has been diagnosed by MRI or other imaging technique to confirm presence of cartilage lesion and the lesion remains symptomatic. Only patients for whom the decision to perform surgery has already been made will be invited to participate. Asymptomatic lesions will NOT be included;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Knee injury and Osteoarthritis Outcome score (KOOS) - year 1(Pain and Sport/Rec only)
Timeframe: baseline (pre-surgery) to 1 year after surgery
. Lesion area of less than of 26.6 mm height and less than 20.0 mm width in the index knee after debridement.
Exclusion criteria
. Age \>65 years or \<18 years at time of enrolment;
. Body Mass Index (BMI) \> 35;
. Lesion area of more than 26.6 mm length and more than 20.0 mm width in the index knee after debridement;
. Patient has multiple lesions to be treated;
. Articular cartilage lesions in the tibia or patella, ICRS grades 3 and above;
. KOOS Pain Subscale score at baseline that is \< 20 or \> 65. (Scale range: Maximum pain = 0, pain free = 100);
. Patient has previously received the FibroFix™ Cartilage P implant;
. Patient suffers from any medical condition that would hinder cartilage repair, such as additional unresolved comorbidities related to the index knee;