Rheumatoid Arthritis 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:

• The hip replacement surgery being performed must follow the approved uses for all devices involved.
• The person is having their first-ever uncemented hip replacement using specific implant components (EMPHASYS cup with a CORAIL, EMPHASYS, or ACTIS stem), performed through one of three accepted surgical approaches with the patient lying on their side.
• The person's surgery is planned to use a specific computer-assisted navigation system called VELYS Hip Navigation with CUPTIMIZE advanced.
• The person is able to speak, read, and understand the consent documents, is willing to give consent to participate, and agrees to share their information with DePuy Synthes.
• The person is willing and able to attend all follow-up appointments required by the study.
• The person is willing and able to complete hip outcome questionnaires (FJS-12, EQ-5D-5L, and a Hip Evaluation form) at the times specified by the study.
• The person is not bedridden, as determined by the treating doctor.
• The person is at least 21 years old at the time of signing the consent form.

Who may not be able to join:

• The person has an active infection anywhere in the body or at the hip site.
• The person has significant muscle, nerve, or blood vessel problems in the affected leg that would make the surgery inadvisable.
• The person has poor bone quality (such as osteoporosis) that, in the surgeon's opinion, creates a meaningful risk of the implant shifting or the bone fracturing, or that does not provide enough bone to support the implant.
• The person has Charcot's joint disease or Paget's disease.
• The person is pregnant or breastfeeding.
• The person has had the opposite leg amputated.
• The person has previously had a partial hip replacement in the hip being treated.
• The person has taken part in a clinical trial involving an investigational drug or device within the last three months.
• The person had their opposite hip replaced less than 6 months before the planned surgery date.
• The person is currently involved in a personal injury lawsuit, medical-legal case, or workers' compensation claim.
• The person has been diagnosed with a muscular condition causing severe stiffness and pain (such as fibromyalgia or polymyalgia) and is currently taking prescription medication for it.
• The person has a medical condition where life expectancy is less than 2 years.
• In the investigator's opinion, the person has a drug or alcohol dependency, or a psychological condition that could affect their ability to complete questionnaires or attend follow-up visits.

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