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

Zimmer Biomet

Status: Terminated

Conditions: Nonunion of Fracture of Fifth Metatarsal

Treatments: Device: EBI Bone Healing System; Procedure: Surgery; Device: Placebo Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00586170

CS-027

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

8 participants in 2 patient groups, including a placebo group

EBI Bone Healing System + Surgery

Experimental group

Description:

Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.

Treatment:

Procedure: Surgery

Device: EBI Bone Healing System

Placebo Device + Surgery

Placebo Comparator group

Description:

Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.

Treatment:

Procedure: Surgery

Device: Placebo Device