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

Launched by SIGNATURE ORTHOPAEDICS · Dec 7, 2023

Keywords

ClinConnect Summary

The Spartan Stem, World Cup, and World Liner Post Market Clinical Follow-up Study is designed to keep track of how well certain hip replacement devices are performing after they have been approved for use. This study is important because it helps ensure that these devices continue to work effectively and safely for patients who have hip replacement surgery.

To participate in this study, you must be between the ages of 18 and 75 and need a hip replacement due to conditions like arthritis or past injuries. You should also be in good overall health, with no serious infections or conditions that might affect the surgery. If you join the study, you will work closely with your doctor and other healthcare professionals, who will monitor your recovery and the performance of the hip replacement devices. This study is currently recruiting participants, and your involvement can help improve the care and outcomes for future patients needing hip replacements.

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.