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
N/A
Total Duration
On this page
Sponsors
S
Signature Orthopaedics
Lead Sponsor
T
The Cleveland Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to monitor the performance and safety of the Everglade Stem, World Acetabular Cup, and World Liner devices used in primary total hip arthroplasty for patients with hip disease. These devices are recently introduced to the market, and the study collects data to confirm their safety, performance, and clinical benefits over a two-year follow-up period. Participants will receive the Everglade Stem, a cementless titanium hip stem with a special coating for bone growth, along with the World Acetabular Cup and World Liner, designed to work together for hip replacement. The study gathers information starting before surgery, at discharge, and at 1-year and 2-year post-operative visits to evaluate device performance and safety. During the study, participants will undergo assessments including measurement of the revision rate of the implants, patient-reported outcomes using the Oxford Hip Score to assess satisfaction, and radiographic analysis to observe bone response to the implants. The total monitoring period is two years, with data collected at several specific time points to evaluate the devices' survival and effectiveness.
CONDITIONS
Brief 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 such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH
- Patient must be a candidate for use of the devices as determined by surgeon and patient
- Male and non-pregnant female patients aged 18 to 75 years
- Patients who understand the clinical evaluation conditions and agree to participate for the full follow-up duration
You will not qualify if you...
- Patient has active infection or sepsis that may compromise implant stability or recovery
- Female of child-bearing age not using contraceptive pills
- Patient has inadequate bone stock to support the device, including severe osteopenia or osteoporosis
- Known or suspected metal sensitivity
- Immunosuppressed patients with diseases such as AIDS or on high-dose corticosteroids
- Emotional or neurological conditions limiting ability or willingness to participate, including mental illness, mental retardation, or drug abuse
- Severely overweight patients with a body mass index over 40
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of surgery to hospital discharge
Participants undergo primary total hip arthroplasty using the Everglade Stem, World Acetabular Cup, and World Liner devices, followed by immediate post-operative care.
1 operative visit and 1 discharge visit
Duration - Up to 2 years post-operation
Participants return for follow-up evaluations including clinical assessments, patient-reported outcomes using the Oxford Hip Score, and radiographic analysis to monitor device performance and safety.
Visits at 1 year and 2 years post-operative
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
D
Declan Brazil, PhD
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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