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OpenTrials
Enrolling by Invitation

NCT Number: NCT07150221

MDR Vivacit-E Elevated 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.

Enrolling by Invitation

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vivacit-E Elevated Liners

Device

Primary total hip arthroplasty

Primary outcomes

  1. Survival of the Implant System via Adverse Events

    Time frame: 10 years

    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.

Secondary outcomes

  1. Pain and functional performance measured by the Oxford Hip Score

    Time frame: 10 years

    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.

  2. Subject quality-of-life measured by the EQ-5D-5L

    Time frame: 10 Years

    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.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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