Actively Recruiting
Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study
Led by Signature Orthopaedics · Updated on 2023-12-15
200
Participants Needed
1
Research Sites
225 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 Spartan Stem, World Acetabular Cup and World Liner as a post-market vigilance and continuous improvement efforts.
CONDITIONS
Official Title
Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study
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 studied products as determined by the surgeon and patient
- Male and non-pregnant female patients aged 18 to 75 years
- Patients who understand the clinical evaluation and agree to participate for the full follow-up period
You will not qualify if you...
- Patient has active infection or sepsis that could compromise implant stability or recovery
- Female of child-bearing age not using contraceptive pills
- Patient has inadequate bone stock to support the device, such as severe osteopenia or osteoporosis
- Patient has known or suspected metal sensitivity
- Patient is immuno-suppressed due to diseases like AIDS or high-dose cortico-steroids
- Patient has emotional or neurological conditions affecting participation, including mental illness, mental retardation, or drug abuse
- Patient is severely overweight with a body mass index over 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 Shejale, MS Ortho
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
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