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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01307384
Other study ID # CMU2010-02H
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 29, 2011
Est. completion date December 2027

Study information

Verified date June 2024
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Device:
Continuum Metal on Polyethylene Acetabular System
Used in primary hip arthroplasty

Locations

Country Name City State
United States Denver Health Medical Center Denver Colorado
United States Sah Orthopaedic Associates Fremont California

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

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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