Clinical Trial: Akin Osteotomy With or Without Fixation

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Is Fixation of Percutaneous Akin Osteotomy Enhanced First Ray Post-operative Mobility? A Prospective Randomized Study.

Brief Summary: The study is a prospective randomized study about hallux valgus surgery. The investigator try to assess if the fixation of percutaneous Akin osteotomy with a cannulated screw have an incidence in the first ray mobility since the two technics ( fixation and no-fixation) are described and practiced, and since the stiffness of the first metatarso-phalangeal joint is determinant in the result of this functional surgery.

Detailed Summary:

It's a prospective monocentric randomized work about forefoot surgery. Every patient included undergoes an hallux valgus chevron osteotomy of the first metatarsal associated with a percutaneous Akin osteotomy of the first phalange. The investigators study the impact of the fixation of percutaneous Akin osteotomy ( osteotomy of the first phalange of hallux) with two arms: one with fixation of the percutaneous Akin osteotomy, and one with a non-fixed percutaneous Akin osteotomy This study as been approved by Institutional review board; written informed consent is required for all patients before inclusion.

The clinic follow-up of each patients included in the study will be the same of the normal follow-up for this type of surgery in our practice. This includes clinical exam, radiologic exam, and functional score AOFAS before surgery, at 6 weeks after the surgery, four months after surgery and finally one year after the surgery.

The primary outcome measure which is the first metatarso-phalangeal global mobility will be blindly measure by an observator.


Sponsor: University Hospital, Bordeaux

Current Primary Outcome: Global Mobility in degrees of the metatarso-phalangeal joint of the hallux one year after the surgery. [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Angle between Metatarsus 1 and Phalanx 1 [ Time Frame: 12 months ]
  • Angle between Metatarsus 1 and Metatarsus 2 [ Time Frame: 12 months ]
  • Angle between Phalanx 1 and Phalanx 2 [ Time Frame: 12 months ]
  • Distal Metatarsal Articular Angle [ Time Frame: 12 months ]
  • DM2A angle, calculated preoperatively by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface [ Time Frame: 12 months ]
  • DM2A angle, calculated at last follow-up by measuring the angle between the metatarsal diaphysis M2 and the tangent at the vertex of the distal articular surface [ Time Frame: 12 months ]
  • Kitaoka Score [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Bordeaux

Dates:
Date Received: October 27, 2016
Date Started: December 2016
Date Completion: June 2019
Last Updated: December 2, 2016
Last Verified: December 2016