Trial Outcomes & Findings for A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures (NCT NCT00586170)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

24 Weeks

Results posted on

2017-06-21

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	5	3
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Double-Blind Study on Adjunctive Use of PEMF in the Treatment of 5th Metatarsal Non-Union Fractures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EBI Bone Healing System + Surgery n=5 Participants 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	Placebo Device + Surgery n=3 Participants 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	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 Weeks

Population: Each patient had 1 fracture. The number of fractures treated equals the number of patients treated in both treatment groups.

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.

Outcome measures

Outcome measures
Measure	EBI Bone Healing System + Surgery n=5 Fractures 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	Placebo Device + Surgery n=3 Fractures 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
Percentage of Successful 5th Metatarsal Unions Achieved.	100 percentage of fractures healed	100 percentage of fractures healed

SECONDARY outcome

Timeframe: 24 Weeks

Population: No AOFAS, Foot Function Index, or SF-36 Health Survey data was collected or analyzed.

Outcome measures

Outcome data not reported

Adverse Events

EBI Bone Healing System + Surgery

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Device + Surgery

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	EBI Bone Healing System + Surgery n=5 participants at risk 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	Placebo Device + Surgery n=3 participants at risk 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
Investigations Unrelated complication - leg bruising, breast lump	0.00% 0/5 • Entire study period. Patients were followed through healing, or up to 24 weeks.	33.3% 1/3 • Number of events 1 • Entire study period. Patients were followed through healing, or up to 24 weeks.
Psychiatric disorders Unrelated complication - anxiety	20.0% 1/5 • Number of events 1 • Entire study period. Patients were followed through healing, or up to 24 weeks.	0.00% 0/3 • Entire study period. Patients were followed through healing, or up to 24 weeks.
Gastrointestinal disorders unrelated complication - hernia	20.0% 1/5 • Number of events 1 • Entire study period. Patients were followed through healing, or up to 24 weeks.	0.00% 0/3 • Entire study period. Patients were followed through healing, or up to 24 weeks.
General disorders unrelated complication - allergic reaction	20.0% 1/5 • Number of events 1 • Entire study period. Patients were followed through healing, or up to 24 weeks.	0.00% 0/3 • Entire study period. Patients were followed through healing, or up to 24 weeks.

Additional Information

Manager of Research

Biomet

Phone: 973-299-9300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place