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:

• People who have a non-inflammatory degenerative joint disease affecting the hip — such as osteoarthritis, bone tissue death (avascular necrosis), arthritis caused by injury, certain hip growth conditions, hip fractures, or a specific bone growth disorder — and who need a first-time total hip replacement on one side only.
• People aged between 65 and 79 years old (inclusive) at the time of enrolling in the trial.
• People considered a suitable candidate for a first-time total hip replacement, as determined by the trial doctor.
• People whose hip pain and function score (called a WOMAC Global Score) is 40 or higher out of 96 when measured within 28 days before surgery, where a higher score indicates worse symptoms.
• People who have signed and dated a consent form agreeing to take part.
• People who are willing and able to attend all required follow-up appointments at the trial site and complete study procedures and questionnaires.

Who may not be able to join:

• People who have had a total hip replacement, partial hip replacement, or hip joint fusion in either hip within the past 12 months.
• People who have a total hip replacement on the opposite hip planned within the next 12 months.
• People who have a known allergy to any part of the hip implant device used in this trial.
• People who have a history of active infection inside the hip joint.
• People whose hip socket or thigh bone does not have enough healthy bone for the implant to attach securely.
• People who are missing all or part of the muscles or ligaments around the hip.
• People who have moderate to severe kidney disease.
• People who have poor blood flow, muscle wasting, or nerve and muscle disease in either leg, as determined by the trial doctor.
• People who have a deformity of the affected leg or a significant unusual shape of the affected hip joint.
• People who have an active cancer or have had an invasive cancer within the last five years — though people who have had certain treated skin cancers, or who had a treated early-stage cervical condition more than one year before enrolling, may still be considered (confirm with trial site).
• People who have any condition that, in the trial doctor's opinion, could affect how well the hip replacement works or affect recovery — for example, certain bone or nerve conditions such as Paget's disease or Charcot's disease.
• People who have rheumatoid arthritis or another autoimmune condition that affects the joints, such as Lupus Arthritis.
• People who have any condition that would make it difficult to accurately report their own pain, physical function, or quality of life during the trial, as determined by the trial doctor.
• People with a Body Mass Index (BMI) of 40 or above.
• People who have an active infection anywhere in the body or at the planned surgery site — for example, hepatitis or HIV/AIDS.
• People who are currently taking part in another investigational (research) study that is unrelated to the care provided before or after this surgery.
• People who have any other serious acute or long-term medical condition that, in the trial doctor's judgement, could affect the trial results or make participation unsuitable.
• People who have a history of metabolic bone disease, such as Paget's disease or osteomalacia (softening of the bones).
• People who are currently pregnant or who are planning to become pregnant.

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