Avascular Necrosis of Bone of Hip, Congenital Hip Dysplasia, Osteoarthritis, Post-traumatic; Arthrosis
Conditions
Brief summary
The objectives of this study are to obtain clinical performance (outcomes) data and survivorship for commercially available Vivacit-E (HXPE) liners. This will be done by analysis of polyethylene wear, validated outcome measurement tools, radiographs, and reported adverse events data.
Detailed description
Safety will be evaluated by monitoring the frequency and incidence of adverse events. Performance will be determined by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Vivacit-E HXPE Liner with the Continuum acetabular shell. In addition, the implanted Vivacit-E HXPE Liners will be evaluated for bedding in, and linear and volumetric wear at 6 weeks and 1, 2, & 5 years postoperatively. Pain and functional performance will be measured using the Harris Hip and High Activity Arthroplasty Scores. Survivorship will be based on removal or intended removal of the device and through analysis of radiographs, and health status will be determined by evaluation of the EQ-5D.
Interventions
DEVICEVivacit-E Liner
All subjects enrolled will receive the Vivacit-E liner.
Sponsors
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patient is 18 to 60 years of age, inclusive. * Patient is skeletally mature. * Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including at least one of the following: * Osteoarthritis * Avascular necrosis (AVN) * Post-traumatic arthritis * Congenital hip dysplasia * Patient has no history of previous total hip replacement or arthrodesis of the affected hip joint(s). * Patient is willing and able to provide written informed consent. * Patient is willing and able to cooperate in the required post-operative therapy. * Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. * Patient has participated in the Informed Consent process and has signed the IRB/EC approved informed consent.
Exclusion criteria
* Patient is unwilling or unable to give consent or to comply with the follow-up program. * Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis, etc. in the affected hip joint(s). * Inflammatory Arthritis * Rheumatoid Arthritis * The patient is: * a prisoner mentally incompetent or unable to understand what participation in the study entails a known alcohol or drug abuser * anticipated to be non-compliant * The patient has an acute, chronic, or systemic infection(s). * The patient has total or partial absence of the muscular or ligamentous apparatus. * The patient has neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation. * The patient has osteoradionecrosis. * The patient has lack of bony structures proximal or distal to the operative joint, so that good implant fixation is unlikely or impossible. * The patient has local bone tumors/cysts in the bone to be retained that the implanting surgeon determines could inhibit implant fixation. * The patient is skeletally immature. * The patient has any concomitant disease that can jeopardize the functioning and the success of the implant. * The patient is known to be pregnant. * The patient has a known sensitivity or allergic reaction to one or more of the implanted materials which include metal (titanium, tivanium, tantalum, cobalt, chromium, nickel) and ceramic.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival of the study device; whether or not it is still implanted in the subject | 10 years | Survival is classified as removal of the study device for any reason |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent Adverse Events (safety) | 10 years | Safety is assessed by monitoring the frequency and incidence of all adverse events, with particular focus on those that may be related to the study device. |
| Harris Hip Score | 10 years | Functional outcomes are measured with the Harris Hip Score, including range of motion, pain level, activity levels and patient satisfaction. |
| Patient activity level | 10 years | Patient activity level is assessed with the High Activity Arthroplasty score, filled out by the patient. |
| Patient Quality of Life | 10 years | This is another self-assessment by means of the EQ-5D score, which measures the patient's perceived quality of life. |
| Radiographic analysis | 2 years | Patient x-rays will undergo an analysis to evaluate radiolucencies, osteolysis, subsidence, cup migration and polyethylene wear. |
Countries
United States
Contacts
STUDY_DIRECTORRyan Boylan, MBA
Zimmer Biomet
Outcome results
None listed