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Vivacit-E Post-market Follow-up Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03226808
Recruitment Status : Active, not recruiting
First Posted : July 24, 2017
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date  ICMJE August 11, 2016
First Posted Date  ICMJE July 24, 2017
Last Update Posted Date May 3, 2022
Actual Study Start Date  ICMJE October 1, 2013
Estimated Primary Completion Date March 2, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2017)
Survival of the study device; whether or not it is still implanted in the subject [ Time Frame: 10 years ]
Survival is classified as removal of the study device for any reason
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
Survival [ Time Frame: 10 years ]
Survival is classified as removal of the study device for any reason
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2017)
  • Incidence of treatment-emergent Adverse Events (safety) [ Time Frame: 10 years ]
    Safety is assessed by monitoring the frequency and incidence of all adverse events, with particular focus on those that may be related to the study device.
  • Harris Hip Score [ Time Frame: 10 years ]
    Functional outcomes are measured with the Harris Hip Score, including range of motion, pain level, activity levels and patient satisfaction.
  • Patient activity level [ Time Frame: 10 years ]
    Patient activity level is assessed with the High Activity Arthroplasty score, filled out by the patient.
  • Patient Quality of Life [ Time Frame: 10 years ]
    This is another self-assessment by means of the EQ-5D score, which measures the patient's perceived quality of life.
  • Radiographic analysis [ Time Frame: 2 years ]
    Patient x-rays will undergo a Martell analysis by Dr. John Martell to evaluate radiolucencies, osteolysis, sbusidence, cup migration and polyethylene wear.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2017)
  • Safety profile of the device [ Time Frame: 10 years ]
    Safety is assessed by monitoring the frequency and incidence of all adverse events, with particular focus on those that may be related to the study device.
  • Function [ Time Frame: 10 years ]
    Functional outcomes are measured with the Harris Hip Score.
  • Patient activity level [ Time Frame: 10 years ]
    Patient activity level is assessed with the High Activity Arthroplasty score, filled out by the patient.
  • Patient Quality of Life [ Time Frame: 10 years ]
    This is another self-assessment by means of the EQ-5D score, which measures the patient's perceived quality of life.
  • Radiographic analysis [ Time Frame: 2 years ]
    Patient x-rays will undergo a Martell analysis by Dr. John Martell to evaluate radiolucencies, osteolysis, sbusidence, cup migration and polyethylene wear.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vivacit-E Post-market Follow-up Study
Official Title  ICMJE Post Market Clinical Follow-up Study of the Zimmer Vivacit-E Highly Crosslinked Polyethylene Liner Used With the Continuum Acetabular Shell
Brief Summary The objectives of this study are to obtain clinical performance (outcomes) data and survivorship for commercially available Vivacit-E (HXPE) liners. This will be done by analysis of polyethylene wear, validated outcome measurement tools, radiographs, and reported adverse events data.
Detailed Description

Safety will be evaluated by monitoring the frequency and incidence of adverse events.

Performance will be determined by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Vivacit-E HXPE Liner with the Continuum acetabular shell.

In addition, the implanted Vivacit-E HXPE Liners will be evaluated for bedding in, and linear and volumetric wear by the Martell 2-D method at 6 weeks and 1, 2, 4, & 5 years postoperatively.

Pain and functional performance will be measured using the Harris Hip and High Activity Arthroplasty Scores. Survivorship will be based on removal or intended removal of the device and through analysis of radiographs, and health status will be determined by evaluation of the EQ-5D.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Avascular Necrosis of Bone of Hip
  • Post-traumatic; Arthrosis
  • Congenital Hip Dysplasia
Intervention  ICMJE Device: Vivacit-E Liner
All subjects enrolled will receive the Vivacit-E liner.
Study Arms  ICMJE Vivacit-E Liner
All subjects enrolled receive the study implant.
Intervention: Device: Vivacit-E Liner
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 19, 2017)
258
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2028
Estimated Primary Completion Date March 2, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is 18 to 60 years of age, inclusive.
  • Patient is skeletally mature.
  • Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including at least one of the following:
  • Osteoarthritis
  • Avascular necrosis (AVN)
  • Post-traumatic arthritis
  • Congenital hip dysplasia
  • Patient has no history of previous total hip replacement or arthrodesis of the affected hip joint(s).
  • 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/EC approved informed consent.

Exclusion Criteria:

  • Patient is unwilling or unable to give consent or to comply with the follow-up program.
  • Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis, etc. in the affected hip joint(s).
  • Inflammatory Arthritis
  • Rheumatoid Arthritis
  • 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 an acute, chronic, or systemic infection(s).
    • The patient has total or partial absence of the muscular or ligamentous apparatus.
    • The patient has neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation.
    • The patient has osteoradionecrosis.
    • The patient has lack of bony structures proximal or distal to the operative joint, so that good implant fixation is unlikely or impossible.
    • The patient has local bone tumors/cysts in the bone to be retained that the implanting surgeon determines could inhibit implant fixation.
    • The patient is skeletally immature.
    • The patient has any concomitant disease that can jeopardize the functioning and the success of the implant.
    • The patient is known to be pregnant.
    • The patient has a known sensitivity or allergic reaction to one or more of the implanted materials which include metal (titanium, tivanium, tantalum, cobalt, chromium, nickel) and ceramic.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03226808
Other Study ID Numbers  ICMJE CMU2011-09H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Zimmer Biomet
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Zimmer Biomet
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ryan Boylan, MBA Zimmer Biomet
PRS Account Zimmer Biomet
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP