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

Nonunion of Fracture of Fifth Metatarsal Clinical Trial

Official title:

A Prospective, Randomized, Double-Blind Study on Adjunctive Use of Pulsed Electromagnetic Fields in the Treatment of 5th Metatarsal Non-Union Fractures: Effect on Clinical Outcome and Growth Factor Synthesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00586170
• Other study ID #: CS-027
• Status: Terminated
• Phase: N/A
• First received: December 21, 2007
• Last updated: June 19, 2017
• Start date: November 2007
• Est. completion date: August 2012

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to analyze the effect of PEMF in surgical reconstruction of 5th metatarsal non-union fractures.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Ununited
• Nonunion of Fracture of Fifth Metatarsal

Intervention

Device:
• EBI Bone Healing System
10 hours of treatment per day for up to 24 weeks
• Placebo Device
10 hours of treatment per day for up to 24 weeks

Procedure:
• Surgery
Open Reduction and Internal Fixation of the nonunion site

Locations

Country	Name	City	State
United States	The Orthopedic Foot and Ankle Center	Columbus	Ohio
United States	Neurological Institute of NJ	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24 Weeks
Secondary	Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline)		24 Weeks