Clinical Trial: Operative Treatment Of Metatarsalgia: Triple Weil Osteotomy Or Distal Metatarsal Minimal Invasive Osteotomy (DMMO)?

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

Official Title: Open Randomized Controlled Clinical Trial To Assess Functional Outcomes Between Two Therapeutic Options In The Surgical Treatment Of Metatarsalgia: Triple Weil Osteotomy (

Brief Summary:

INTRODUCTION

Metatarsalgia is a vague term defining a symptom instead of a specific condition. The aim of surgical treatment of metatarsalgia is to decrease the pressure under metatarsal head, shortening and / or raising the metatarsal. It has been somewhat controversial, with more than 25 different lesser metatarsal osteotomies described to date.

The Triple´s Weil osteotomy described by Maceira is the most widely used surgical treatment in open distal metatarsal surgery but nowadays, percutaneous osteotomy has proven to be a valid technique that yields results similar to open osteotomy for the treatment of metatarsalgia and other forefoot problems. It has been somewhat controversial the choice between the different operative treatments, being nowadays the triple´s Weil osteotomy (TWO) and the distal minimally invasive osteotomy (DMMO) the most popular, gaining both defenders and retractors surgeons in open and percutaneous surgery.

The purpose of this study is to compare the clinical results between two different surgical treatments: triple´s Weil osteotomy (TWO) and distal minimal invasive osteotomy (DMMO).

MATERIAL AND METHODS

The investigators design an open randomized controlled clinical trial with patients operated in the same centre.

The patients are randomized to TWO and DMMO groups. Number of osteotomies is based on the criteria of Leventen formula. In all patients the metatarsal osteotomy can be combined with different surgical procedures in presence of associated deformities: (i) SCARF osteotomy for hallux valgus (HV) deformity, (ii) flexor and extensor tenotomies with distal phalangeal percutaneous o

Detailed Summary:

INTRODUCTION

Metatarsalgia is a vague term defining a symptom instead of a specific condition. The aim of surgical treatment of metatarsalgia is to decrease the pressure under metatarsal head, shortening and / or raising the metatarsal, thus removing the overload and preserving the joint integrity. It has been somewhat controversial, with more than 25 different lesser metatarsal osteotomies described to date. The Weil osteotomy is the most widely used surgical treatment in open distal metatarsal surgery, a popularity based upon the simple technique, stable fixation, excellent union rates and predictable results.

According to the principles of traditional surgery, surgical manoeuvres requiring large incisions and aggressive techniques should be needed to effectively resolve the different pathological elements producing the deformity in order to eliminate this serious injury. These principles concerns surgeons like White, who described a modification of the distal metaphyseal osteotomy through a percutaneous approach without visualization and without internal fixation to obtain a metatarsal in optimal weight-bearing position. Percutaneous surgery of the foot, also known as minimal invasive surgery (MIS), allows interventions to be carried out through extremely small incisions without direct exposure of the surgical field under radiologic monitoring, thus causing minimal injury to adjacent tissues, and reducing the surgical trauma. Over the last few years, Foot Surgery has come to be recognised as a major Orthopaedic subspecialty, where the percutaneous surgery plays an important role. The Triple´s Weil osteotomy described by Maceira is the most widely used surgical treatment in open distal metatarsal surgery but nowadays, percutaneous osteotomy has proven to be a valid technique that yields results similar to open osteo
Sponsor: Manuel Cuervas-Mons

Current Primary Outcome:

  • Change from Baseline American Orthopaedic Foot and Ankle Society score (AOFAS) at 3 and 12 months [ Time Frame: Preoperative, 3 months follow-up and 12 months follow-up ]
    Score for pain, function and alignment
  • Change from Baseline Short form Health survey 36 (SF-36) at 3 and 12 months [ Time Frame: Preoperative, 3 months follow-up and 12 months follow-up ]
    Score for quality of life
  • Change from Baseline Visual Analog Score (VAS) at 3 and 12 months [ Time Frame: Preoperative, 3 months follow-up and 12 months follow-up ]
    Score for pain
  • Benton-Weil´s questionnaire [ Time Frame: 12 months follow-up ]

    The questionnaire incorporate actual VAS and clinical results subjectively evaluated with three questions:

    (i) Does the surgery meet your expectations? (ii) Would you recommend the procedure to a friend in similar conditions? (iii) Would you have undergone the procedure, knowing now your outcome?



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from 3 months MTPJ joint mobility at 12 months [ Time Frame: 3 months follow-up and 12 months follow-up ]

    Metatarso-phalangeal joint (MTPJ) mobility described as the range of motion (ROM) of the joint, measured by a goniometer MTPJ range of motion is measured in a open chain patient who is lying down with the knee extended and the foot at rest in spontaneous plantar flexion.

    Full ROM of plantar flexion combined with dorsiflexion was classified in: normal ROM ≥70º, moderately stiff ROM 30º to 70º, and severely stiff ROM < 30º..

  • Change from Baseline Metatarsal formula at 12 months [ Time Frame: Preoperative and 12 months follow-up ]
    Changes in the radiological metatarsal formula are measured with the average recoil of the metatarsal heads between the preoperative and the 12 months follow up measurement.


Original Secondary Outcome: Same as current

Information By: Hospital General Universitario Gregorio Marañon

Dates:
Date Received: July 5, 2016
Date Started: July 2016
Date Completion: September 2018
Last Updated: August 9, 2016
Last Verified: August 2016