Vivacit-E Post-market Follow-up Study

Post Market Clinical Follow-up Study of the Zimmer Vivacit-E Highly Crosslinked Polyethylene Liner Used With the Continuum Acetabular Shell

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis; Congenital Hip Dysplasia; Post-traumatic; Arthrosis; Avascular Necrosis of Bone of Hip
• Intervention / Treatment: Device: Vivacit-E Liner

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
• Enrollment (Actual): 258
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Parker, Colorado, United States, 80134
      • Denver Hip and Knee, Inc.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Department of Orthopaedics University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Institute
  • Texas
    • Austin, Texas, United States, 78751
      • Texas Institute for Hip and Knee Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vivacit-E Liner; All subjects enrolled receive the study implant.	Device: Vivacit-E Liner; All subjects enrolled will receive the Vivacit-E liner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of the study device; whether or not it is still implanted in the subject	Survival is classified as removal of the study device for any reason	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent Adverse Events (safety)	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.	10 years
Harris Hip Score	Functional outcomes are measured with the Harris Hip Score, including range of motion, pain level, activity levels and patient satisfaction.	10 years
Patient activity level	Patient activity level is assessed with the High Activity Arthroplasty score, filled out by the patient.	10 years
Patient Quality of Life	This is another self-assessment by means of the EQ-5D score, which measures the patient's perceived quality of life.	10 years
Radiographic analysis	Patient x-rays will undergo a Martell analysis by Dr. John Martell to evaluate radiolucencies, osteolysis, sbusidence, cup migration and polyethylene wear.	2 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Ryan Boylan, MBA, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Estimated): March 2, 2026
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bone Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Osteoarthritis; Necrosis; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Osteonecrosis
• Other Study ID Numbers: CMU2011-09H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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