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The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.
The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.
The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.
The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).
*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taperloc Complete Stems | Patients that have been implanted with a Taperloc Complete Stem to repair hip malfunction/disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taperloc Complete Stem | Device | Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events. | The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to either implant or instrumentation should be specified. | Out to 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Device Performance and Benefits evaluated through the Harris Hip Score | The HHS is divided into 4 sub-categories; pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). Patients select a discrete set of answers which correspond to predefined point allocations based on the category. To obtain a final score, these values are summed. | Out to 10 Years |
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Inclusion Criteria:
Exclusion Criteria:
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A consecutive series of patients implanted with the Taperloc Complete Stems in primary or revision total hip arthroplasty according to the approved indications.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan McKinnie | Contact | +1 (919) 381-7091 | megan.mckinnie@zimmerbiomet.com | |
| Lynsey Boyle | Contact | +1 (412) 552-7111 | Lynsey.Boyle@zimmerbiomet.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Institute of Henderson | Withdrawn | Henderson | Nevada | 89052 | United States | |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D025981 | Hip Injuries |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| Device Performance and Benefits evaluated through the Oxford Hip Score | The OHS is a patient-completed, 12-question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms. | Out to 10 Years |
| Texas Health Physicians Group |
| Recruiting |
| Plano |
| Texas |
| 75243 |
| United States |
|
| Proliance Orthopaedics and Sports Medicine | Withdrawn | Bellevue | Washington | 98004 | United States |