Rheumatoid Arthritis Clinical Trial
Official title:
Prospective Post Market Clinical Follow-Up Study of the Continuum Metal on Polyethylene Acetabular System
Verified date | June 2024 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 165 |
Est. completion date | December 2027 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria - Patient is 18 to 75 years of age, inclusive. - Patient is skeletally mature. - Patient qualifies for primary unilateral or bilateral (simultaneous or staged) total hip arthroplasty (THA) based on physical exam and medical history including the following: - Avascular necrosis (AVN) - Osteoarthritis - Inflammatory arthritis (i.e., Rheumatoid arthritis) - Post-traumatic arthritis - Patient has no history of previous prosthetic replacement device of any type, including surface replacement arthroplasty, endoprosthesis, etc. of the affected hip joint(s). - Patient has moderate, marked or disabling pain. - Patient is willing and able to provide written informed consent. - Patient is willing and able to cooperate in the required post-operative therapy. - Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. - Patient has participated in the Informed Consent process and has signed the IRB approved informed consent. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Denver Health Medical Center | Denver | Colorado |
United States | Sah Orthopaedic Associates | Fremont | California |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Metal Ion / Cobalt | Blood specimens analyzed for a subset of all enrolled study subjects to use as a comparator to blood levels in patients being studied under a separate clinical protocol. Adverse events reported for levels outside of normal range. | Pre-operatively and at 6 months, 1 year, 2 year and 5 years | |
Other | Metal Ion / Chromium | Blood specimens analyzed for a subset of all enrolled study subjects to use as a comparator to blood levels in patients being studied under a separate clinical protocol. Adverse events reported for levels outside of normal range. | Pre-operatively and at 6 months, 1 year, 2 year and 5 years | |
Other | Metal Ion / Titanium | Blood specimens analyzed for a subset of all enrolled study subjects to use as a comparator to blood levels in patients being studied under a separate clinical protocol. Adverse events reported for levels outside of normal range. | Pre-operatively and at 6 months, 1 year, 2 year and 5 years | |
Other | Renal Function / BUN | Blood specimens analyzed for a subset of all enrolled study subjects to use as a comparator to blood levels in patients being studied under a separate clinical protocol. Adverse events reported for levels outside of normal range. | Pre-operatively and at 6 months, 1 year, 2 year and 5 years | |
Other | Renal Function / Creatinine | Blood specimens analyzed for a subset of all enrolled study subjects to use as a comparator to blood levels in patients being studied under a separate clinical protocol. Adverse events reported for levels outside of normal range. | Pre-operatively and at 6 months, 1 year, 2 year and 5 years | |
Other | Renal Function / GFR | Blood specimens analyzed for a subset of all enrolled study subjects to use as a comparator to blood levels in patients being studied under a separate clinical protocol. Adverse events reported for levels outside of normal range. | Pre-operatively and at 6 months, 1 year, 2 year and 5 years | |
Primary | Survivorship | Based on removal or intended removal of the device and determined using the Kaplan-Meier method. | 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year | |
Primary | 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. | Surgery, 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year | |
Secondary | Pain and Function / HHS | Pain and function will be measured using the Harris Hip Score self assessment. | 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year | |
Secondary | Pain and Function / OHS | Pain and function will be measured using the Oxford Hip Score self assessment. | 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year | |
Secondary | Health Status / SF-12 | Health status will be measured using the SF-12 self assessment. | 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year | |
Secondary | 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. | 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year |
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