Nonunion of Fracture of Fifth Metatarsal
Conditions
Keywords
nonunion, fracture
Brief summary
The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.
Detailed description
The investigators hypothesize: 1. That treatment of 5th metatarsal non-union fracture with PEMF will achieve earlier resolution and/or higher success compared to surgery alone of 5th metatarsal non-union fractures. 2. PEMF will stimulate increased expression of critical growth factors (i.e. BMP-2, BMP-4, BMP-7 as well as TGFb, IGF-1, FGF-2 and VEGF) at the non-union site to facilitate osseous healing of 5th metatarsal non-union fractures.
Interventions
DEVICEEBI Bone Healing System
10 hours of treatment per day for up to 24 weeks
DEVICEPlacebo Device
10 hours of treatment per day for up to 24 weeks
PROCEDURESurgery
Open Reduction and Internal Fixation of the nonunion site
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has been diagnosed with a 5th metatarsal delayed or non-union. 2. Subjects with duration of a 5th metatarsal fracture for a minimum of 3 months. 3. Male or female between ages of 18 and 75 years old, inclusive
Exclusion criteria
1. Subject has synovial pseudarthrosis. 2. Subject has a fracture gap of larger than 5mm as measured on CT Scan. 3. Subjects with conditions associated with elevated circulatory levels of inflammatory cytokines e.g., multiple trauma. 4. If female, subject is pregnant, plans on becoming pregnant during the duration of this clinical outcomes collection study or lactating. 5. Subject has an implanted unipolar pacemaker. 6. Subjects who have previous malignant or connective tissue disorder. 7. Subjects who use medication such as steroids or anticoagulants. 8. Subjects who have an underlying osseous infection (Osteomyelitis) and/or open wound.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Successful 5th Metatarsal Unions Achieved. | 24 Weeks | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline) | 24 Weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| 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 | 3 |
| Total | 8 |
Baseline characteristics
| Characteristic | EBI Bone Healing System + Surgery | Placebo Device + Surgery | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 8 Participants |
| Region of Enrollment United States | 5 participants | 3 participants | 8 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 5 | 1 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 3 |
Outcome results
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.
Time frame: 24 Weeks
Population: Each patient had 1 fracture. The number of fractures treated equals the number of patients treated in both treatment groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EBI Bone Healing System + Surgery | Percentage of Successful 5th Metatarsal Unions Achieved. | 100 percentage of fractures healed |
| Placebo Device + Surgery | Percentage of Successful 5th Metatarsal Unions Achieved. | 100 percentage of fractures healed |
Secondary
Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)
Time frame: 24 Weeks
Population: No AOFAS, Foot Function Index, or SF-36 Health Survey data was collected or analyzed.