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MDR Vivacit-E Elevated Study

NCT ID: NCT07150221

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-10

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis (OA) of the Hip Avascular Necrosis of Bone of Hip Protrusio Acetabuli Traumatic Arthropathy-Hip Slipped Capital Femoral Epiphyses Fused Hip Fracture of Pelvis Diastrophic Variant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Vivacit-E Elevated Liners

Patients previously implanted with Vivacit-E Elevated Liners.

Vivacit-E Elevated Liners

Intervention Type DEVICE

Primary total hip arthroplasty

Interventions

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Vivacit-E Elevated Liners

Primary total hip arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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South Bend Orthopaedics

South Bend, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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MDRG2017-89MS-106H

Identifier Type: -

Identifier Source: org_study_id