Status:
UNKNOWN
Origin Stem and Logical Cup Post Market Clinical Follow-up
Lead Sponsor:
Signature Orthopaedics
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Hip Disease
Eligibility:
All Genders
18-75 years
Brief Summary
The aim of the study is to monitor the performance of the Signature Orthopaedics Origin Stem and Logical Acetabular Cup as part of post-market vigilance and continuous improvement efforts.
Detailed Description
The objective of this PMCF study is to collect data confirming safety, performance and clinical benefits of the Origin Stem and Logical Cup when used for primary total hip arthroplasty at 2 years foll...
Eligibility Criteria
Inclusion
- 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
- patient has active infection or sepsis (treated or untreated)
- patient has any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
- patient is female of child-bearing age and not taking contraceptive precautions
- patient has inadequate bone stock to support the device (e.g. severe osteopenia, family history of severe osteoporosis or osteopenia)
- patient has inflammatory joint disease (e.g. rheumatoid arthritis)
- patient has known moderate to severe renal deficiency
- patient has a known or suspected metal sensitivity
- patient is immuno-suppressed with diseases such as AIDS or is receiving high dose of corticosteroids
- 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.
Key Trial Info
Start Date :
November 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 19 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04123600
Start Date
November 19 2019
End Date
November 19 2023
Last Update
September 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195