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

U

University of Padova

Status

Unknown

Conditions

Metatarsalgia Bilateral

Treatments

Procedure: Distal Metatarsal Metaphyseal Osteotomy (DMMO)

Study type

Observational

Funder types

Other

Identifiers

NCT03639103
4064/AO/17

Details and patient eligibility

About

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.

Full 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).

Enrollment

200 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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 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.

Trial contacts and locations

1

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Central trial contact

LODOVICA GAMBATO, DR; CARLO BIZ, MD

Data sourced from clinicaltrials.gov

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