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

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ClinicalTrials.gov Identifier: NCT01307384
Recruitment Status : Active, not recruiting
First Posted : March 2, 2011
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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
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 Type : Observational
Estimated 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
Study Start Date : March 2012
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: Total Hip Replacement, Total Hip Arthroplasty, Primary Hip




Primary Outcome Measures :
  1. Survivorship [ Time Frame: 10 Years ]
    Based on removal or intended removal of the device and determined using the Kaplan-Meier method.


Secondary Outcome Measures :
  1. Pain and Functional Performance [ Time Frame: 10 Years ]
    Measurements will be based on the Harris Hip Score (HHS) and Oxford Hip Score (OHS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from surgeons medical practice who are candidates for primary hip arthroplasty.

The study population will be comprised of 300 males and females who require primary total hip arthroplasty. Subjects will be enrolled at up to 7 clinical sites. Subjects must be geographically accessible throughout the study and be willing and able to attend required follow-up appointments. Candidates who express interest in study participation will be offered informed consent, and eligibility will be determined based upon the inclusion/exclusion criteria.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307384


Locations
United States, California
Sah Orthopaedic Associates
Fremont, California, United States, 94538
United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: Peggy Essick Zimmer Biomet

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01307384     History of Changes
Other Study ID Numbers: CMU2010-02H
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Zimmer Biomet:
Total Hip Arthroplasty
Total Hip Replacement (THR)
Primary Hip Arthroplasty
THA
THR

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Necrosis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes