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Slow enrollment and poor patient follow-up following enrollment
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The purpose of this clinical registry is to capture data on an ongoing basis from a population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.
The purpose of this clinical registry is to capture current, real-world, bone specific healing data from the medical records of patients being treated with a Biomet® EBI Bone Healing System (BHS), the Biomet® OrthoPak® Non-Invasive Bone Growth Stimulator System, or the Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System. This study will provide current data on the effectiveness of these electrical stimulation devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation Group | All patients will receive either the Biomet® EBI Bone Healing System, Biomet OrthoPak® Non-invasive Bone Growth Stimulator System or Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator Systems. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomet® EBI Bone Healing System | Device | A pulsed electromagnetic fields electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 3-10 hours per day with a recommended use of 10 hours per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Assessment of Healing | Bone healing was assessed on x-rays and/or CT scan. | The time frame for healing determination was not pre-specified. Patients were evaluated at regular doctors' visits for up to 12 months. The physician determined the time point at which healing occurred for each patient at their regular visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Assessment | Quality of life was intended to be measured by 5 scoring systems that ask a range of questions about the patient's pain and function. No quality of life data was captured for any of the patients and as such no quality of life analysis was performed. | The quality of life assessment was to be completed at the regular doctor's visit at which the physician determined the patient to be healed. No quality of life data was collected. |
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Inclusion Criteria:
Exclusion Criteria:
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This clinical registry will be a prospective, multi-center study. Subjects will undergo treatment with Biomet's BHS or OrthoPak devices for non-spinal applications.
Subjects will undergo treatment with Biomet's SpinalPak for spinal applications
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| Name | Affiliation | Role |
|---|---|---|
| Randy Graham | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cumberland Orthopedics | Vineland | New Jersey | 08360 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stimulation Group | All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Biomet Orthopak® Non-Invasive Bone Growth Stimulator System | Device | A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day. |
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| Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator | Device | A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stimulation Group | All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radiographic Assessment of Healing | Bone healing was assessed on x-rays and/or CT scan. | All patients, with one nonunion fracture each, were treated with the Biomet EBI Bone Healing System. Four patients had final healing outcomes reported (two patients with a 5th metatarsal nonunion, one patient with a tibial nonunion and one patient with a fibula nonunion) and all healed in an average time of 2.5 months. | Posted | Number | percentage of healed fractures | The time frame for healing determination was not pre-specified. Patients were evaluated at regular doctors' visits for up to 12 months. The physician determined the time point at which healing occurred for each patient at their regular visits. | Fractures | Fractures |
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| Secondary | Quality of Life Assessment | Quality of life was intended to be measured by 5 scoring systems that ask a range of questions about the patient's pain and function. No quality of life data was captured for any of the patients and as such no quality of life analysis was performed. | No quality of life data was collected for any of the patients enrolled in the study. As such, no analysis was performed on quality of life measures. | Posted | The quality of life assessment was to be completed at the regular doctor's visit at which the physician determined the patient to be healed. No quality of life data was collected. |
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Adverse event data was collected for the entire period that each of the patients was followed. Patients were followed up to 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stimulation Group | All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems. | 0 | 8 | 0 | 8 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Research | Biomet | 973-299-9300 | 3415 | hallie.murray@zimmerbiomet.com |
| ID | Term |
|---|---|
| D004194 | Disease |
| D005599 | Fractures, Ununited |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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