Clinical trial NCT03639103: Clinical and Radiographic Outcomes of Distal Metatarsal Metaphyseal Osteotomy for Central Primary Metatarsalgia
Official title: Medium-Long-Term Clinical and Radiographic Outcomes of Minimally Invasive Distal Metatarsal Metaphyseal Osteotomy for Central Primary Metatarsalgia and Predictive Value of Maestro Criteria
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metatarsalgia Bilateral
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of central primary metatarsalgia between M2 and M4 of a biomechanical etiology in the plantar foot area are enrolled consecutively and prospectively with precise inclusion criteria. Ages range from 18 to 90 years.

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the 100-point hallux metatarsophalangeal-interphalangeal scale (AOFAS) changes
timeFrame: preoperatively, 3-, 6-, 12-months
measure: Evaluation of the Foot Functional Index changes
timeFrame: preoperatively, 3-, 6-, 12-months
measure: Evalutation of the Manchester-Oxford Foot Questionnaire changes
timeFrame: preoperatively, 3-, 6-, 12-months
Secondary outcomes:
measure: Radiographic classification according to Maestro and Besse criteria
timeFrame: before surgery, at one-month after surgery and at different follow-ups (3-, 6-, 12-month, and last)
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Padua Univeristy Orthopaedic Clinic
Study officials:
affiliation: Padua University Orthopaedic Clinic
name: Carlo Biz, MD
role: PRINCIPAL_INVESTIGATOR
References: