MDR Vivacit-E Elevated Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vivacit-E Elevated Liners.
- Who it may be relevant to
- Registry conditions: Osteoarthritis (OA) of the Hip, Avascular Necrosis of Bone of Hip, Protrusio Acetabuli, Traumatic Arthropathy-Hip. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Device Vivacit-E Elevated Liners
Primary total hip arthroplasty
Primary outcome measures
- Survival of the Implant System via Adverse Events [Time frame: 10 years]
Secondary outcome measures (2)
- Pain and functional performance measured by the Oxford Hip Score [Time frame: 10 years]
- Subject quality-of-life measured by the EQ-5D-5L [Time frame: 10 Years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- South Bend Orthopaedics — South Bend
Identifiers
NCT: NCT07150221 · MDRG2017-89MS-106H