Osteoarthritis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 30 and 65 years old.
• Your knee quality-of-life score (measured by a questionnaire called KOOS) is 60 or below, meaning your knee significantly affects your daily life.
• You are willing and able to follow all study requirements, including post-surgery rehabilitation and follow-up appointments.
• You have a knee cartilage injury that did not improve after at least 2 months of non-surgical treatments (such as anti-inflammatory medications, injections, or physical therapy), or that did not improve after surgery (such as a cleaning-out procedure or bone realignment) performed at least 12 months ago, and your doctor believes surgery is now appropriate.
• Your cartilage damage is located on the rounded end of the thigh bone (femoral condyle) or the groove at the front of the knee (trochlear facet).
• Your cartilage damage is rated as a moderate to severe level on a standard medical scale (ICRS grade 2, 3, or 4).
• Your cartilage damage area is small enough to fit within specific size limits set by the trial (confirm with trial site for exact measurements).
• The bone beneath your damaged cartilage is strong enough to support the implant, as confirmed by the surgeon during the procedure.

Who may not be able to join:

• Your body mass index (BMI) is 35 or higher.
• You have been diagnosed with an autoimmune form of arthritis (such as rheumatoid arthritis).
• You have advanced, severe arthritis in the knee being treated, either confirmed by imaging or found during surgery.
• Your other knee has known cartilage, meniscus, or ligament problems, widespread arthritis, or needs surgery.
• You have been diagnosed with gout, or have had gout symptoms in the past 12 months.
• You are currently less than 2 months into a non-surgical treatment for your cartilage problem, or it has been less than 12 months since a surgical treatment for your cartilage in the same knee.
• Your cartilage injury has already been treated with certain advanced procedures (ACI, OATS, or donor cartilage grafts) that did not work.
• Your knee is significantly out of alignment (more than 5 degrees in either direction when bearing weight).
• There is cartilage damage on both sides of the same knee compartment (sometimes called "kissing lesions") beyond a mild level.
• You have significant ligament instability in the knee being treated that has not been corrected (confirm with trial site for specific details).
• You have had your entire meniscus (the cushioning cartilage in your knee) removed.
• You have previously had a partial knee replacement involving the kneecap area in the knee being treated.
• You have uncontrolled diabetes.
• You have any condition, medication, or treatment known to prevent bones from healing properly.
• You have had an active infection in your body or in the knee being treated within the past 12 months.
• You have an allergy to titanium alloy, a type of medical-grade plastic (UHMWPE), or hyaluronic acid.
• You are pregnant or plan to become pregnant at any point during the study (for female patients).
• You have legal issues or other circumstances that could prevent you from completing two years of follow-up appointments.
• You are currently taking part in another medical study or receiving another treatment in the same knee.
• You have a torn meniscus in the knee being treated that has not been addressed (some partial repairs may still be acceptable — confirm with trial site).
• You have additional moderate-to-severe cartilage damage in other areas of the same knee that also needs treatment.
• Your cartilage damage would require more than one implant to cover it.
• The bone beneath your cartilage damage is found to be too weak or unhealthy to support the implant during surgery (though in some cases, the surgeon may use bone cement as an alternative — confirm with trial site).
• You have been diagnosed with osteoporosis, low bone density, or another bone metabolism condition, as confirmed by specific medical tests.

Important: Always verify eligibility with the trial site directly before applying.