MDR Vivacit-E Elevated Study

Post-Market Clinical Follow-Up Study of the Vivacit-E Vitamin E Highly Crosslinked Polyethylene HXLPE Elevated Liners in Primary THA- A Retrospective Enrollment/Prospective Follow-Up Study

The main objective of this study is to confirm long-term safety, performance, and clinical benefits of the Vivacit-E Vitamin E HXLPE Elevated Liners when used in primary total hip arthroplasty.

Study Overview

• Status: Enrolling by invitation
• Conditions: Avascular Necrosis of Bone of Hip; Slipped Capital Femoral Epiphyses; Traumatic Arthropathy-Hip; Fracture of Pelvis; Protrusio Acetabuli; Diastrophic Variant; Fused Hip; Osteoarthritis (OA) of the Hip
• Intervention / Treatment: Device: Vivacit-E Elevated Liners

• Study Type: Observational
• Enrollment (Estimated): 52

Contacts and Locations

Study Locations

• United States
  • Indiana
    • South Bend, Indiana, United States, 46635
      • South Bend Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population should consist of a maximum of 52 subjects implanted 10 years ago with the Vivacit-E Vitamin E HXLPE Elevated Liner in total hip arthroplasty, according to the approved indications.

Description

Inclusion Criteria:

• Patient was 18 years of age or older and skeletally mature at the time of surgery
• Patient qualified for and underwent surgical procedure with a Vivacit-E Vitamin E HXLPE Elevated Liner to treat one of the following indications in primary THA:
• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Protrusio acetabuli
• Traumatic arthritis
• Slipped capital epiphysis
• Fused hip
• Fracture of the pelvis
• Diastrophic variant
• Patient underwent surgical procedure 10 years (+ no maximum/- 182 days) prior to date of study consent
• Patient is will and able to sign IRB approved Informed Consent Form or provide verbal consent

Exclusion Criteria:

• Off label use or not according to the approved IFU at the time of surgery
• Patient presented with any of the following at the time of the surgical procedure:
• Osteoradionecrosis
• Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation
• Systemic or local infection
• Revision procedure where other treatment or devices have failed*
• Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent

• Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions

  • For the purpose of this clinical study; a revision procedure refers to a procedure in which the prior procedure on the ipsilateral hip utilized a similar approach (i.e., primary total hip arthoplasty)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vivacit-E Elevated Liners; Patients previously implanted with Vivacit-E Elevated Liners.	Device: Vivacit-E Elevated Liners; Primary total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of the Implant System via Adverse Events	The primary endpoint is defined by the survival of the implant system at 10 years post-operative, which is based on removal of the study device and will be determined using the Kaplan Meier method. The safety of the study device will be assessed by monitoring the frequency and incidence of adverse events.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and functional performance measured by the Oxford Hip Score	The Oxford Hip Score measures pain and function together, reflecting how hip symptoms impact a patient's severity and frequency of hip-related pain and their physical capabilities.	10 years
Subject quality-of-life measured by the EQ-5D-5L	The EQ-5D-5L is a standardized questionnaire that measures health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It provides an overall assessment of a participant's perceived health status.	10 Years

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 29, 2025
• First Submitted That Met QC Criteria: August 29, 2025
• First Posted (Actual): September 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Wounds and Injuries; Arthritis; Joint Diseases; Rheumatic Diseases; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Osteochondrodysplasias; Bone Diseases, Developmental; Epiphyses, Slipped; Osteoarthritis; Hip Fractures; Slipped Capital Femoral Epiphyses
• Other Study ID Numbers: MDRG2017-89MS-106H

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.: No