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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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

Detailed Summary:

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.

Sponsor: Zimmer Biomet

Current Primary Outcome: Percentage of Successful 5th Metatarsal Unions Achieved. [ Time Frame: 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.


Original Primary Outcome: The primary outcome measure for this trial will be the percentage of successful 5th metatarsal unions achieved. [ Time Frame: 24 Weeks ]

Current Secondary Outcome: Mean AOFAS Score (% Change From Baseline), Foot Function Index (% Change From Baseline), SF-36 Health Survey (Change From Baseline) [ Time Frame: 24 Weeks ]

Original Secondary Outcome: Same as current

Information By: Zimmer Biomet

Dates:
Date Received: December 21, 2007
Date Started: November 2007
Date Completion:
Last Updated: April 11, 2016
Last Verified: September 2012