Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up

Launched by SIGNATURE ORTHOPAEDICS · Nov 22, 2023

Keywords

ClinConnect Summary

The Everglade Stem, World Cup, and World Liner Post Market Clinical Follow-up study is looking at how well certain hip replacement products perform after they are already on the market. These products are used in surgeries for patients who have hip diseases caused by conditions like osteoarthritis or traumatic injuries. The main goal of the study is to ensure these devices are safe and effective for patients, and to gather information that can help improve them over time.

To be eligible for this trial, participants must be between 18 and 75 years old and need a hip replacement due to non-inflammatory issues. They should be able to understand the study and agree to follow-up appointments. However, people with certain health conditions, like active infections or severe osteoporosis, or those who are severely overweight, may not qualify. If you decide to join, you can expect to participate in regular check-ins to monitor your recovery and the performance of the hip replacement products. This study is currently recruiting participants, so if you're interested and meet the criteria, you can discuss it further with your doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • patient requires unilateral primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia/DDH)
• • patient must be a candidate for use of the products studied, as determined jointly by the surgeon and patient
• • male and non-pregnant female patients aged 18-75
• • patients who understand the conditions of the clinical evaluation and are willing to participate for the length of the prescribed follow-up
• Exclusion Criteria:
• • patient has active infection or sepsis(treated or untreated) enough to compromise implant stability or postoperative recovery
• • patient is a female of child-bearing age and not taking and not taking contraceptive pills
• • patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
• • patient has a known or suspected metal sensitivity
• • patient is immuno-suppressed with disease such as AIDS or is receiving high dose of cortico-steroids.
• • patient has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the clinical evaluation including mental illness, mental retardation or drug abuse
• • patient is severely overweight with a BMI\>40.