Status:
ENROLLING_BY_INVITATION
MDR Vivacit-E Elevated Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis (OA) of the Hip
Avascular Necrosis of Bone of Hip
Eligibility:
All Genders
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT07150221
Start Date
October 10 2025
End Date
December 1 2027
Last Update
November 13 2025
Active Locations (1)
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1
South Bend Orthopaedics
South Bend, Indiana, United States, 46635