This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used in primary total hip arthroplasty.
The safety and performance of the Continuum Metal on Polyethylene Acetabular System will be confirmed by the assessment of survival and outcome data. Assessments will include standard scoring systems, radiographs and adverse event records. Data will be used to monitor pain, mobility, and survivorship of the Continuum Metal on Polyethylene Acetabular system in primary total hip arthroplasty. Metal ion (cobalt, chromium and titanium) and renal function (BUN, Creatinine and GFR) levels will be analyzed for a subset of the enrolled study subjects.
Study Type
OBSERVATIONAL
Enrollment
165
Used in primary hip arthroplasty
Sah Orthopaedic Associates
Fremont, California, United States
Denver Health Medical Center
Denver, Colorado, United States
Survivorship
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Safety / Adverse Events
Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.
Time frame: Surgery, 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Pain and Function / HHS
Pain and function will be measured using the Harris Hip Score self assessment.
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Pain and Function / OHS
Pain and function will be measured using the Oxford Hip Score self assessment.
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Health Status / SF-12
Health status will be measured using the SF-12 self assessment.
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Health Status / Radiographic Parameters
X-rays will be evaluated for acetabular cup angle, acetabular cup migration, femoral stem position, femoral stem subsidence and femoral stem shift.
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
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