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The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).
The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup and the Endo II Femoral Head when used for hip hemiarthroplasty (implants and instrumentation).
The primary objective of this study is the assessment of safety by analyzing implant survivorship at the longest follow-up timepoint available, greater than or equal to eight years post-implantation. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to implant, instrumentation and/or procedure should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RingLoc Bipolar Acetabular Cup | Patients that have been implanted with the RingLoc Bipolar acetabular cup to repair hip malfunction/disease/injury. |
| |
| Endo II Femoral Heads | Subjects who were implanted with the Endo II Femoral head during hemiarthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RingLoc Bipolar Acetabular Cup | Device | Patients that have been implanted with a RingLoc Bipolar acetabular cup. |
|
| 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 will be specified. | Greater than or equal to 8 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Device Performance and Benefits evaluated through the Oxford Hip Score and Patient Assessment. | 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. The Patient Assessment is patient completed and a 4-question evaluation. | Greater than or equal to 8 years. |
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Inclusion Criteria:
Patient must be 18 years of age or older and skeletally mature
Patient must have undergone hip hemiarthroplasty surgery with the RingLoc Bipolar Acetabular Cup or Endo II Femoral Head for a cleared indication, greater than or equal to eight years previous to the date of study consent. Cleared indications for the RingLoc Bipolar and Endo II Heads include the following:
Exclusion Criteria:
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A consecutive series of patients implanted with the RingLoc Bipolar acetabular cup or the Endo II Femoral Head.
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| Name | Affiliation | Role |
|---|---|---|
| Lynsey Boyle | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | 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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| Endo II Femoral Head | Device | Subjects that have been implanted with an Endo II Femoral Head |
|