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 a man or woman aged 40 to 79 years old at the time of signing the consent form.
• You have been diagnosed with knee osteoarthritis (a condition where the cartilage in the knee wears down) according to standard medical guidelines, either at or within 24 weeks before your first study visit.
• You have had pain in your affected knee for at least 8 weeks.
• An X-ray of your knee shows a moderate level of osteoarthritis severity (rated grade I, II, or III on a standard medical scale called the Kellgren-Lawrence scale) (confirm with trial site).
• Your knee pain scores at least 40 mm out of 100 mm on a standard pain measurement scale when you put weight on it.
• Your Body Mass Index (BMI — a measure of body weight relative to height) is below 35.
• You are able to walk without a walking aid such as a cane or walker — or, if you have been regularly using one for at least 24 weeks before your first visit, you may still be able to participate using that same device throughout the trial.
• You are willing to sign a consent form agreeing to take part in the trial.
• You are able to understand the trial procedures and attend all required visits.

Who may not be able to join:

• You have had surgery on the study knee (including keyhole or joint-cleaning surgery) within the 24 weeks before your first study visit.
• You have had any arthroscopic (keyhole) treatment on the study knee within the 24 weeks before your first study visit.
• Doctors feel you need surgery on the study knee right now.
• Your study knee shows significant looseness or instability in the ligaments (the tissues that hold the joint together) on physical examination (confirm with trial site).
• Your study knee has bone fractures or significant misalignment (such as being notably bow-legged or knock-kneed) that could interfere with the treatment.
• Your knee pain appears to be coming from nearby joints (such as the hip) rather than, or in addition to, the knee itself, in a way that could make it hard to assess the knee pain.
• You have certain other health conditions, including: rheumatoid arthritis, gout, fibromyalgia, psoriatic arthritis, joint infection, osteonecrosis, amyloidosis, serious liver, heart or kidney disease, a cancer diagnosis within the last 5 years, or a blood clotting disorder such as haemophilia (confirm with trial site for full list).
• There is an active infection or inflammation in the study knee.
• There is a large build-up of fluid in the study knee.
• You have a skin condition or problem at the area of the study knee.
• You have an allergy or sensitivity to products derived from pigs.
• You have had an allergic reaction or bad reaction to any ingredients in the device being studied in this trial (confirm with trial site).

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