Clinical Trial: Study of Treatment of Lisfranc Injuries

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multi-center, Prospective, Randomised Study of Treatment of Lisfranc Injuries

Brief Summary: This trial is designed to compare different treatments on Lisfranc fractures. The trial consist of 2 different strata. Stratum 1: In mild injuries the comparison is between conservative treatment and operative treatment with open reduction and internal fixation (ORIF). Stratum 2: In severe injuries the comparison is between operative treatment with open reduction and internal fixation (ORIF) and primary arthrodesis. The primary outcome measure will be AOFAS Midfoot Score, and secondary outcome measure will be VAS Foot and Ankle.

Detailed Summary: The aim of this study is to find out the most effective way to treat Lisfranc injuries
Sponsor: Tampere University Hospital

Current Primary Outcome:

• AOFAS Midfoot Scale [ Time Frame: 12 months ]
  Between group difference in the functional outcome of the foot measured with AOFAS Midfoot Scale which is a subjective and objective evaluation of the midfoot based on questions in function (45 points), pain (40 points), and alignment (15 points) with a total score between 0 (worst score) and 100 (perfect score).
• AOFAS Midfoot Scale [ Time Frame: 24 months ]
  Between group difference in the functional outcome of the foot measured with AOFAS Midfoot Scale which is a subjective and objective evaluation of the midfoot based on questions in function (45 points), pain (40 points), and alignment (15 points) with a total score between 0 (worst score) and 100 (perfect score).

Original Primary Outcome: Same as current

Current Secondary Outcome:

• VAS Foot and Ankle [ Time Frame: 12 months ]
  Between group differences in pain and function of the foot measured with Visual Analog Scale of the Foot and Ankle (FA VAS). FA VAS scale is a self-administered patient questionnaire based on 20 questions in three different question categories (pain, function and other complaints). The total value of all questions is 2000. This total value is divided with 20 resulting in a possible score from 0 to 100 points, where 100 is the perfect score.
• VAS Foot and Ankle [ Time Frame: 24 months ]
  Between group differences in pain and function of the foot measured with Visual Analog Scale of the Foot and Ankle (FA VAS). FA VAS scale is a self-administered patient questionnaire based on 20 questions in three different question categories (pain, function and other complaints). The total value of all questions is 2000. This total value is divided with 20 resulting in a possible score from 0 to 100 points, where 100 is the perfect score.
• VAS Pain [ Time Frame: 6 weeks ]
  Between group difference in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).
• VAS Pain [ Time Frame: 10 weeks ]
  Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).
• VAS Pain [ Time Frame: 4 months ]
  Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).
• VAS Pain [ Time Frame: 6 months ]
  Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).
• VAS Pain [ Time Frame: 12 months ]
  Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).
• VAS Pain [ Time Frame: 24 months ]
  Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).

Original Secondary Outcome: Same as current

Information By: Tampere University Hospital

Dates:
Date Received: October 24, 2016
Date Started: March 2012
Date Completion: December 2020
Last Updated: November 1, 2016
Last Verified: October 2016