Osteoarthritis Trial, Recruiting

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

Who might be able to join this trial:

• People aged 14 to 64 years old (those aged 14 to 21 must have imaging showing their hip bones have finished growing)
• People with a body mass index (BMI) under 35
• People who have already tried at least 6 weeks of non-surgical treatment, such as pain or anti-inflammatory medications, physiotherapy, or injections, without sufficient relief
• People who have had hip pain (in the groin, outer hip, or back of the hip) lasting at least 3 months
• People who have a specific area of cartilage damage (roughly 1 to 6 square centimetres) on the ball of the hip joint, confirmed by MRI, without damage on the opposing surface, that could be treated with a single ReNew Hip Implant
• People whose hip X-ray shows the joint space is still greater than 2 mm wide
• People who are considered medically safe for surgery, in the opinion of the treating investigator
• People who have agreed to take part in the study and signed the required consent form after having the study explained to them
• People who are able to understand their role in the study and are available for follow-up appointments for up to five years after surgery

Who may not be able to join:

• People who currently use any form of nicotine (such as cigarettes, vaping, chewing tobacco, patches, gum, or lozenges), or who stopped using nicotine fewer than 30 days before their screening appointment
• People with Type 1 or Type 2 Diabetes
• People who have used systemic (whole-body) steroid medications in the 3 months before screening
• People with certain hip bone shape conditions (such as coxa plana, coxa magna, or proximal femoral focal deficiency) that would mean the implant would not fit the shape of the hip correctly
• People with any ongoing or long-term health condition that would limit their ability to take part in the study, such as serious lung or heart conditions (confirm with trial site)
• People with bleeding disorders
• People with a current cancer diagnosis, except for certain non-melanoma skin cancers
• People who are pregnant or planning to become pregnant during the study period
• People with an active infection or serious widespread infection (sepsis)
• People with a history of infection in the hip joint
• People with known cancer that has spread to other parts of the body, or known tumour-related disease
• People with conditions that may affect how well the implant works or lasts, such as severe hip socket abnormalities (confirm with trial site)
• People with a life expectancy of less than 2 years
• People who have had any injection or other treatment directly into the hip joint within 3 months of enrolling
• People whose bone quality is assessed as insufficient to support the implant (based on specific bone assessment tools used by the trial site)
• People whose femoral head (the ball part of the hip joint) measures outside the 46 to 56 mm range, or has an irregular shape that would result in a poor fit with the implant
• People with moderate to severe kidney disease
• People with emotional or neurological conditions that would affect their ability or willingness to participate in the study
• People who have had an above-knee amputation on either leg
• People with a known allergy to polycaprolactone, the material the device is made from
• People who are currently incarcerated

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