Everglade Stem, World Cup and World Liner Post Market Clinical Follow-up
ConditionHip Disease
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 Everglade Stem, World Acetabular Cup and World Liner as a part of post-market vigilance and continuous improvement efforts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 population
Patients of the Cleveland Clinic
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Treatment
DeviceThe Everglade™ Stem, is a second generation cementless blade style hip stem Forged in Titanium and proximally Antero-Posterior (AP) flared with Titanium Plasma Spray + Hydroxyapatite (TPS + HA) coated for bone on-growth. The stem has distal geometry and a polished anodized surface finish to minimize the stem hanging in Dorr A femurs. The World Acetabular Cup is a porous coated and mated with the Cross-linked polyethylene World Liner
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Everglade Stem, World Cup and World Liner Survival Rate
The implant survival rate based on removal of the device for any reason as determined following the Kaplan-Meier method
Time frame
upto 2 yearsSecondary outcomes
1
Oxford Hip Score (OHS)
The OHS is a patient reported outcome measure (PROM) used to quantify patient satisfaction with the treatment. The OHS consists of 12 questions scored 1 to 5 by the patient.
Time frame
up to 2 yearsOther outcomes
1
Radiographic Analysis
Post-operative radiographs of the implant are analysed to identify locations and sizes of radiolucency, indicative of poor fixation. The size, location and progression of radiolucencies is monitored. Smaller, non-progressive radiolucencies are preferred.
Time frame
up to 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Signature Orthopaedics
Lead sponsor
The Cleveland Clinic
Collaborator
Source ClinicalTrials.gov