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

Not Applicable

Terminated

• Conditions: Nonunion of Fracture of Fifth Metatarsal
• Interventions: Device: Placebo Device; Device: EBI Bone Healing System; Procedure: Surgery

• Registration Number: NCT00586170
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-04
• Primary Completion: 2011-08
• Study Completion: 2012-08
• Results First Submitted: 2016-03-09
• Results First Submitted QC: 2016-04-11
• Results First Posted: 2016-05-16
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EBI Bone Healing System + Surgery	Surgery	Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
Placebo Device + Surgery	Placebo Device	Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.
EBI Bone Healing System + Surgery	EBI Bone Healing System	Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.
Placebo Device + Surgery	Surgery	Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)	24 Weeks

Trial Locations

Locations (2)

The Orthopedic Foot and Ankle Center; 🇺🇸 Columbus, Ohio, United States

Neurological Institute of NJ; 🇺🇸 Newark, New Jersey, United States