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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vivacit-E Elevated Liners | Patients previously implanted with Vivacit-E Elevated Liners. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivacit-E Elevated Liners | Device | Primary total hip arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival of the Implant System via Adverse Events | 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and functional performance measured by the Oxford Hip Score | 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. | 10 years |
| Subject quality-of-life measured by the EQ-5D-5L |
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Inclusion Criteria:
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
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The study population should consist of a maximum of 52 subjects implanted 10 years ago with the Vivacit-E Vitamin E HXLPE Elevated Liner in total hip arthroplasty, according to the approved indications.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Bend Orthopaedics | South Bend | Indiana | 46635 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D060048 | Slipped Capital Femoral Epiphyses |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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. |
| 10 Years |
| D010009 |
| Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D004839 | Epiphyses, Slipped |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |