Actively Recruiting
Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up
Led by Signature Orthopaedics · Updated on 2023-12-01
200
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
Sponsors
S
Signature Orthopaedics
Lead Sponsor
T
The Cleveland Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of the Study is to monitor the performance of the Signature Orthopaedics Everglade Stem, World Acetabular Cup and World Liner as a part of post-market vigilance and continuous improvement efforts.
CONDITIONS
Official Title
Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Satish A Shejale, M.S. Orthopaedics
CONTACT
D
Declan Brazil, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here