Clinical and Radiographic Outcomes of Distal Metatarsal Metaphyseal Osteotomy for Central Primary Metatarsalgia

Last updated: August 16, 2018
Sponsor: University of Padova
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03639103
4064/AO/17
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The primary propose of this prospective study is to specifically evaluate the safety and effectiveness of Minimally Invasive Distal Metatarsal Metaphyseal Osteotomy (DMMO) in treating patients with persistent central primary metatarsalgia, associated or not to hallux valgus and lesser toe deformities, identifying possible contraindications in relation to some demographic parameters (age, gender, BMI, and smoking). The second objective is to verify the potential of DMMO in restoring a harmonious foot morphotype according to Maestro's criteria and if these radiographic parameters are correlated with clinical outcomes, maintaining the predictive value of these criteria during preoperative planning also for this percutaneous surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • forefoot persistent pain;

  • presence or not of forefoot plantar hyperkeratosis lesions;

  • ineffective conservative and orthotic treatment performed for at least 6 months.

Exclusion

Exclusion Criteria:

  • arthritis and stiffness of MTP joint;

  • congenital deformities of the foot;

  • hallux rigidus;

  • Freiberg infraction;

  • Morton's neuroma;

  • diagnosis of rheumatic, metabolic, neurologic, infective, or psychiatric pathologies;

  • previous trauma;

  • foot and ankle surgery,

  • any form of secondary or iatrogenic metatarsalgia.

Study Design

Total Participants: 200
Study Start date:
January 01, 2009
Estimated Completion Date:
December 31, 2021

Study Description

A consecutive series of patients with metatarsalgia is consecutively enrolled and treated by DMMO. According to Maestro criteria, pre-operative planning is carried out by both clinical and radiological assessment. Patient demographic data, AOFAS scores, 17-Foot Functional Index, Manchester-Oxford Foot Questionnaire, SF-36, VAS, and complications are recorded. Maestro parameters, relative morphotypes, and bone callus formation are assessed. Statistical analysis is carried out (p < 0.05).

Connect with a study center

  • Padua Univeristy Orthopaedic Clinic

    Padova, 35128
    Italy

    Active - Recruiting

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