Vivacit-E Post-market Follow-up Study

NCT03226808 | Active Not Recruiting FDA Device

• 1 other identifier: CMU2011-09H
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of treatment-emergent Adverse Events (safety)

  10 years

• Harris Hip Score

  10 years

• Patient activity level

  10 years

• Patient Quality of Life

  10 years

• Radiographic analysis

  2 years

Study Arms (1)

Vivacit-E Liner

OTHER

All subjects enrolled receive the study implant.

Device: Vivacit-E Liner

Interventions

Vivacit-E Liner DEVICE

All subjects enrolled will receive the Vivacit-E liner.

Vivacit-E Liner

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (5)

Denver Hip and Knee, Inc.

Parker, Colorado, 80134, United States

Location

Department of Orthopaedics University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Texas Institute for Hip and Knee Surgery

Austin, Texas, 78751, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Hip Dislocation, Congenital

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ryan Boylan, MBA

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: July 24, 2017
• Study Start: October 1, 2013
• Primary Completion: March 2, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)