Vivacit-E Post-market Follow-up Study

NCT ID: NCT03226808

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-01
• Study Completion Date: 2028-06-30

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.

Conditions

Osteoarthritis; Avascular Necrosis of Bone of Hip; Post-traumatic; Arthrosis; Congenital Hip Dysplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vivacit-E Liner

All subjects enrolled receive the study implant.

Group Type: OTHER

Vivacit-E Liner

Intervention Type: DEVICE

All subjects enrolled will receive the Vivacit-E liner.

Interventions

Vivacit-E Liner

All subjects enrolled will receive the Vivacit-E liner.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Boylan, MBA

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

Denver Hip and Knee, Inc.

Parker, Colorado, United States

Department of Orthopaedics University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

OrthoCarolina Research Institute

Charlotte, North Carolina, United States

Rothman Institute

Philadelphia, Pennsylvania, United States

Texas Institute for Hip and Knee Surgery

Austin, Texas, United States

Countries

United States

Other Identifiers

CMU2011-09H

Identifier Type: -

Identifier Source: org_study_id