Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study

Sponsor

Zimmer Biomet (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01307384

Collaborator

(none)

300

Enrollment

Locations

164.1

Anticipated Duration (Months)

150

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Avascular Necrosis Osteoarthritis Inflammatory Arthritis Post-traumatic Arthritis Rheumatoid Arthritis	Device: Continuum Metal on Polyethylene Acetabular System

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

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Post Market Clinical Follow-Up Study of the Continuum Metal on Polyethylene Acetabular System

Actual Study Start Date :

Mar 29, 2011

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Continuum Acetabular System Patients receiving primary hip arthroplasty using the Continuum Metal on Polyethylene Acetabular System	Device: Continuum Metal on Polyethylene Acetabular System Used in primary hip arthroplasty Other Names: Total Hip Replacement, Total Hip Arthroplasty, Primary Hip

Arm

Intervention/Treatment

Continuum Acetabular System

Patients receiving primary hip arthroplasty using the Continuum Metal on Polyethylene Acetabular System

Device: Continuum Metal on Polyethylene Acetabular System

Used in primary hip arthroplasty

Other Names:

Total Hip Replacement, Total Hip Arthroplasty, Primary Hip

Outcome Measures

Primary Outcome Measures

Survivorship [10 Years]
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

Secondary Outcome Measures

Pain and Functional Performance [10 Years]
Measurements will be based on the Harris Hip Score (HHS) and Oxford Hip Score (OHS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.