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The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU).
The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU).
Safety will be established by recording the incidence and frequency of complications and adverse events. Relationship of the events to either implant or instrumentation should be specified.
Performance and clinical benefits will be assessed by analyzing fracture healing/fusion and the overall pain and functional performance of subjects who received the Biomet Cannulated Bone Screws by recording survey questions. Zimmer Biomet defines the expected performance rate for Cannulated Screws for long and small bone fractures to be a union rate of at least 81% at 8-12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small Screws | Patients who have surgically been treated with a 3.0mm or 4.0mm screw. |
| |
| Large Screws | Patients who have surgically been treated with a 5.0mm, 6.5mm or 8.0mm screw. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws. | Device | Treatment of identified conditions, i.e. fracture fixation, arthrodesis, osteotomy, with a cannulated screw. |
| Measure | Description | Time Frame |
|---|---|---|
| Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events | Assessment of safety by recording and analyzing the incidence and frequency of revisions, complications, and adverse events. | Out to12+ months |
| Measure | Description | Time Frame |
|---|---|---|
| Device Performance and Clinical Benefits Assessed by a Patient Questionnaire Case Report Form | Performance and clinical benefits demonstrated by the assessment of survey questions. | Out to 12+ months |
| Device Performance and Clinical Benefits Assessed by a Follow-Up Analysis Case Report Form |
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Inclusion Criteria:
All patients operated on for the following indications:
Group 1, Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
Group 2, Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
Group 3, Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
Patients must have the ability and willingness to follow instructions, including control of weight and activity levels.
Patient must have a good nutritional state.
Exclusion Criteria:
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The study populations will be a consecutive series of subjects that have received the Biomet Cannulated Screw. Patients will be enrolled into one of the two identified groups: Small Screws (3.0mm and 4.0mm), or Large Screws (5.0mm, 6.5mm and 8.0mm).
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Overholser | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zimmer Biomet | Warsaw | Indiana | 46580 | United States | ||
| Orthopedic Foot and Ankle Center |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D000069076 | Fractures, Multiple |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009104 | Multiple Trauma |
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Performance and clinical benefits demonstrated by the assessment of fracture healing/fusion and survey questions. |
| Out to 12+ months |
| Worthington |
| Ohio |
| 43085 |
| United States |
| Associated Foot & Ankle Centers of Northern Virginia | Lake Ridge | Virginia | 22192 | United States |