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Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Arthroplasty Implant | Device | Single study group either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with other Wright Medical Technology (WMT) or MicroPort Orthopedics Inc (MPO) THA components including acetabular shells, liners and femoral heads. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Component Survivorship | The primary objective of this study is to estimate component survivorship of the PROFEMUR® Preserve Classic Femoral Stem out to 10 years follow-up. | 10 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the cumulative revision rate at specified intervals out to 10 years follow-up | Percentage of hips that were revised or replaced at each of the intervals for Year 1, Year 3, Year 5, Year 7 and Year 10 evaluation. | 10 years post-operative |
| Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by HOOS. |
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Inclusion Criteria:
1. Has previously undergone or currently has determined to undergo primary THA with the specified combination of components: PROFEMUR® Preserve Classic Stem combined with other Wright Medical Technologies (WMT) or MPO THA components including acetabular shells, acetabular liners and femoral heads.
2. Has previously undergone or currently has been determined to undergo a primary THA for any of the following:
Exclusion Criteria:
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Subjects either newly or previously implanted with the PROFEMUR® Preserve Classic Stem combined with other Wright MEdical Technology (WMT) or MPO THA components.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Assini, MD | OrthoOne at Swedish Medical Center | Principal Investigator |
| Judd Cummings, MD | HonorHealth Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| HCA Research Institute, OrthoONE at Swedish Medical Center |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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The study will be reporting the final Hip Disability and Osteoarthritis Outcome Score (HOOS) which ranges from 0 to 100 with a score of 0 indicating worst hip symptoms and 100 indicating no hip symptoms. |
| 10 years post-operative |
| Complete characterization (mean, minimum, maximum, standard deviation) of functional scores out to 10 years as assessed by EQ-5D-5L | EQ-5D-5L data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 5 levels: no problems, slight problem, moderate problem, severe problem, inability to perform the activity. With no problems being the best outcome and inability to perform the activity being worst outcome. | 10 years post-operative |
| To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Forgotten Joint Score (FJS). | The study will be reporting forgotten joint score measures for the assessment of joint-specific patient reported outcomes. The questions focus on the patients' awareness of the implanted joint in everyday life or any unintended perception of a joint. | 10 years post-operative |
| To determine proportion of subjects being satisfied and level of their satisfaction as assessed by the Satisfaction Survey. | The Satisfaction Survey consists of questions asked about how satisfied the patient is with the new implant. | 10 years post-operative |
| To evaluate the presence of zones of radiolucencies surrounding the implanted femoral stem | Radiolucencies are described around 7 zones and will be reporting the number of hips with radiolucencies present at a given zone. | 10 years post-operative |
| To characterize adverse events and adverse device effects | Adverse Events will be summarized as the total number of Adverse Events (AE), Adverse Device Effects (ADE) by grade, severity, and relationship to the device and surgery. Number of patients experiencing such AEs and ADEs will also be provided. | 10 years post-operative |
| Englewood |
| Colorado |
| 80113 |
| United States |
| D009336 |
| Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |