ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Avascular Necrosis of Bone of Hip Post-traumatic; Arthrosis Congenital Hip Dysplasia Device: Vivacit-E Liner Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Market Clinical Follow-up Study of the Zimmer Vivacit-E Highly Crosslinked Polyethylene Liner Used With the Continuum Acetabular Shell
Study Start Date : March 2013
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Vivacit-E Liner
All subjects enrolled receive the study implant.
Device: Vivacit-E Liner
All subjects enrolled will receive the Vivacit-E liner.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Patient activity level [ Time Frame: 10 years ]
    Patient activity level is assessed with the High Activity Arthroplasty score, filled out by the patient.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03226808


Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: Jordan Graft Clincal Project Specialist

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03226808     History of Changes
Other Study ID Numbers: CMU2011-09H
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Osteoarthritis
Necrosis
Joint Diseases
Hip Dislocation
Hip Dislocation, Congenital
Osteonecrosis
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Joint Dislocations
Bone Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities