An interventional study of EBI Bone Healing System and Placebo Device in Nonunion of Fracture of Fifth Metatarsal, sponsored by Zimmer Biomet. Terminated at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-06-21.
Sponsored by Zimmer Biomet · Not applicable, Interventional, and Treatment
The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.
The investigators hypothesize:
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 8 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Zimmer Biomet is the lead sponsor of 271 studies on the registry; 28 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
Device: EBI Bone Healing System · Procedure: Surgery
Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
Device: Placebo Device · Procedure: Surgery
10 hours of treatment per day for up to 24 weeks
10 hours of treatment per day for up to 24 weeks
Open Reduction and Internal Fixation of the nonunion site
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
Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)
Time frame: 24 Weeks
| Milestone | EBI Bone Healing System + Surgery | Placebo Device + Surgery |
|---|---|---|
| Started | 5 | 3 |
| Completed | 5 | 3 |
| Not completed | 0 | 0 |
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.
| percentage of fractures healed | EBI Bone Healing System + Surgery | Placebo Device + Surgery |
|---|---|---|
| Percentage of Successful 5th Metatarsal Unions Achieved. | 100 | 100 |
No measurements were reported for this outcome.
Collected over Entire study period. Patients were followed through healing, or up to 24 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EBI Bone Healing System + Surgery | — | 0/5 (0%) | 3/5 (60%) |
| Placebo Device + Surgery | — | 0/3 (0%) | 1/3 (33.3%) |
| Event | EBI Bone Healing System + Surgery | Placebo Device + Surgery |
|---|---|---|
| Unrelated complication - leg bruising, breast lumpInvestigations | 0/5 | 1/3 |
| Unrelated complication - anxietyPsychiatric disorders | 1/5 | 0/3 |
| unrelated complication - herniaGastrointestinal disorders | 1/5 | 0/3 |
| unrelated complication - allergic reactionGeneral disorders | 1/5 | 0/3 |
| Age, Categorical(Participants) | EBI Bone Healing System + Surgery | Placebo Device + Surgery | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 3 | 8 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | EBI Bone Healing System + Surgery | Placebo Device + Surgery | Total |
|---|---|---|---|
| Female | 4 | 2 | 6 |
| Male | 1 | 1 | 2 |
| Region of Enrollment(participants) | EBI Bone Healing System + Surgery | Placebo Device + Surgery | Total |
|---|---|---|---|
| United States | 5 | 3 | 8 |
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Zimmer Biomet