Prospective Post Market Clinical Follow-Up Study of the Continuum Metal on Polyethylene Acetabular System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Zimmer Biomet
- Enrollment
- 165
- Locations
- 2
- Primary Endpoint
- Survivorship
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •The patient is:
- •A prisoner
- •Mentally incompetent or unable to understand what participation in the study entails
- •A known alcohol or drug abuser
- •Anticipated to be non-compliant
- •The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure or complications in postoperative care.
- •The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
- •The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
- •The patient is known to be pregnant.
- •The patient is unwilling or unable to give consent or to comply with the follow-up program.
- •The patient has received an investigational drug or device within the previous 6 months.
- •The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.
- •The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e., osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock.
- •The patient has osteoradionecrosis in the affected hip joint.
- •The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.
- •The patient has known local bone tumors and/or cysts in the operative hip.
- •The patient has a Body Mass Index (BMI) > 40.
Outcomes
Primary Outcomes
Survivorship
Time Frame: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Safety / Adverse Events
Time Frame: Surgery, 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.
Secondary Outcomes
- Pain and Function / OHS(6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year)
- Health Status / Radiographic Parameters(6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year)
- Pain and Function / HHS(6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year)
- Health Status / SF-12(6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year)