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Slow enrollment
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The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.
The investigators hypothesize:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBI Bone Healing System + Surgery | Experimental | Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site. |
|
| Placebo Device + Surgery | Placebo Comparator | Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBI Bone Healing System | Device | 10 hours of treatment per day for up to 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Successful 5th Metatarsal Unions Achieved. | Each patient was assessed radiographically at 2, 4, 6, 8, 12, 16, 20, and 24 weeks or until radiographic signs of healing were evident. The radiographs were evaluated and graded by the number of cortices (medial and lateral on anteroposterior views as well as dorsal and plantar on lateral views) of healing at each time point. Bridging callus across 4 cortices on postoperative radiographs was used to determine healing. | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline) | 24 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Evangelista | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurological Institute of NJ | Newark | New Jersey | 07103 | United States | ||
| The Orthopedic Foot and Ankle Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | EBI Bone Healing System + Surgery | Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site. EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks Surgery: Open Reduction and Internal Fixation of the nonunion site |
| FG001 | Placebo Device + Surgery | Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site. Placebo Device: 10 hours of treatment per day for up to 24 weeks Surgery: Open Reduction and Internal Fixation of the nonunion site |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EBI Bone Healing System + Surgery | Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site. EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks Surgery: Open Reduction and Internal Fixation of the nonunion site |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Successful 5th Metatarsal Unions Achieved. | Each patient was assessed radiographically at 2, 4, 6, 8, 12, 16, 20, and 24 weeks or until radiographic signs of healing were evident. The radiographs were evaluated and graded by the number of cortices (medial and lateral on anteroposterior views as well as dorsal and plantar on lateral views) of healing at each time point. Bridging callus across 4 cortices on postoperative radiographs was used to determine healing. | Each patient had 1 fracture. The number of fractures treated equals the number of patients treated in both treatment groups. | Posted | Number | percentage of fractures healed | 24 Weeks | Fractures | Fractures |
|
Entire study period. Patients were followed through healing, or up to 24 weeks.
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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 | EBI Bone Healing System + Surgery | Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site. EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks Surgery: Open Reduction and Internal Fixation of the nonunion site |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated complication - leg bruising, breast lump | Investigations | Systematic Assessment | 2 months post surgery patient had a lump in left breast and severe bruising on right leg. Could not be associated with device use. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager of Research | Biomet | 973-299-9300 | 3415 | hallie.murray@zimmerbiomet.com |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Placebo Device | Device | 10 hours of treatment per day for up to 24 weeks |
|
| Surgery | Procedure | Open Reduction and Internal Fixation of the nonunion site |
|
| Columbus |
| Ohio |
| 43231 |
| United States |
| Placebo Device + Surgery |
Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site. Placebo Device: 10 hours of treatment per day for up to 24 weeks Surgery: Open Reduction and Internal Fixation of the nonunion site |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo Device + Surgery | Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site. Placebo Device: 10 hours of treatment per day for up to 24 weeks Surgery: Open Reduction and Internal Fixation of the nonunion site |
|
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| Secondary | Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline) | No AOFAS, Foot Function Index, or SF-36 Health Survey data was collected or analyzed. | Posted | 24 Weeks |
|
|
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | Placebo Device + Surgery | Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site. Placebo Device: 10 hours of treatment per day for up to 24 weeks Surgery: Open Reduction and Internal Fixation of the nonunion site | 0 | 3 | 1 | 3 |
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| Unrelated complication - anxiety | Psychiatric disorders | Systematic Assessment | increased anxiety due to cast reported 3 weeks post-surgery. Patient recovered. |
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| unrelated complication - hernia | Gastrointestinal disorders | Systematic Assessment | patient had vomiting and hernia obstruction 6 weeks post-surgery; had hernia surgery and recovered |
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| unrelated complication - allergic reaction | General disorders | Systematic Assessment | patient had sick stomach on surgery day, 3 days later reported allergic reaction - increased swelling of the face, hands and legs. Discontinued medication and swelling discontinued. Vomiting and diarrhea reported 3 wks post-surgery. patient recovered |
|
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