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The objective of this post-market clinical study is to evaluate efficacy outcomes and complication rates in patients who have received the Fibulockâ„¢ Intramedullary Nail.
This is a retrospective/prospective, multi-site observational study, designed to evaluate the clinical outcomes and complication rates in subjects who were previously implanted with a Fibulockâ„¢ intramedullary nail.
Patients will be screened for eligibility and subgroupings. Informed consent will be obtained from those who meet screening criteria and are interested in participating in the study.
Sites will be asked to enroll subjects according to past treatment, with the Fibulockâ„¢ intramedullary nail for unstable fibula fracture. The sites will enroll subjects in the study based on inclusion/exclusion criteria.
Patient pre-operative, intra-operative and post-operative records will be reviewed retrospectively. Once enrolled, subjects will undergo an evaluation of fracture outcome and complete a VAS pain score, SF-12, and Foot Function Index at 26 weeks and again at 52 weeks post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilon Fractures | Patients who are implanted with Fibulock and have a Pilon fracture |
| |
| High Risk Patients | Patients who are implanted with Fibulock and are at high risk of complications from ankle surgery due to conditions such as diabetes, advanced age or osteoporosis |
| |
| Otherwise Healthy Patients | Patients implanted with Fibulock who are healthy other than their ankle fracture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibulock | Device | Fibulock intramedullary implant will be used to repair fibula fractures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Assessment post implantation with Fibulock Intramedullary Nail assessed using lateral and mortice view x-rays | Lateral and mortice view x-rays at 26 weeks | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | Patient self reported pain intensity. | 26 weeks and 52 weeks |
| SF 12 | SF 12 is a Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who received the Fibulock Intramedullary Nailand are at least 12 weeks post implant, but less than 31 weeks post implant.
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| Name | Affiliation | Role |
|---|---|---|
| Terrence Philbin, MD | Orthopedic Foot & Ankle | Principal Investigator |
| Selene Parekh, MD | NCOC | Principal Investigator |
| Chris Hodgkins, MD | Baptist Health South Florida, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Health South Florida | Miami | Florida | 33146 | United States | ||
| NCOC |
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| ID | Term |
|---|---|
| D000092504 | Fibula Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| 26 weeks and 52 weeks |
| Foot Function Index | The Foot Function Index (FFI) is used to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. | 26 weeks and 52 weeks |
| Durham |
| North Carolina |
| 27707 |
| United States |
| Orthopedic Foot & Ankle Center | Westerville | Ohio | 43082 | United States |