MDR Vivacit-E Elevated Study
Enrolling by invitation
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT07150221
- Run by
- Zimmer Biomet
- People needed
- 52
- Starts
- 2026-01-07
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- South Bend Orthopaedics — South Bend, Indiana, United States
Full record on ClinicalTrials.gov
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