Avascular Necrosis of Bone of Hip, Diastrophic Variant, Fracture of Pelvis, Fused Hip, Osteoarthritis (OA) of the Hip, Protrusio Acetabuli, Slipped Capital Femoral Epiphyses, Traumatic Arthropathy-Hip
Conditions
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.
Interventions
DEVICEVivacit-E Elevated Liners
Primary total hip arthroplasty
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain and functional performance measured by the Oxford Hip Score | 10 years | The Oxford Hip Score measures pain and function together, reflecting how hip symptoms impact a patient's severity and frequency of hip-related pain and their physical capabilities. |
| Subject quality-of-life measured by the EQ-5D-5L | 10 Years | The EQ-5D-5L is a standardized questionnaire that measures health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It provides an overall assessment of a participant's perceived health status. |
Countries
United States
Outcome results
None listed