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:
- 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.
- 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 ]
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