Clinical Trials in the USA / NCT07150221
Enrolling by invitation
Observational
MDR Vivacit-E Elevated Study
NCT07150221 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Osteoarthritis (OA) of the HipAvascular Necrosis of Bone of HipProtrusio AcetabuliTraumatic Arthropathy-HipSlipped Capital Femoral EpiphysesFused HipFracture of PelvisDiastrophic Variant
Investigational drug(s) / intervention(s)
Vivacit-E Elevated Liners
Vivacit-E Elevated Liners: Primary total hip arthroplasty
Study 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
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)
Primary outcome measure(s)
- Survival of the Implant System via Adverse Events — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| South Bend Orthopaedics | South Bend | Indiana |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07150221 on ClinicalTrials.gov ↗ ← All trials in the USA