Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study
ConditionHip Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorSignature Orthopaedics
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Spartan Stem, World Acetabular Cup and World Liner
Treatment groups
No treatment groups listed
Sponsors and collaborators
Signature Orthopaedics
Lead sponsor
The Cleveland Clinic
Collaborator
Source ClinicalTrials.gov