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

NCT ID: NCT03639103

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-01
• Study Completion Date: 2021-12-31

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).

Conditions

Metatarsalgia Bilateral

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Distal Metatarsal Metaphyseal Osteotomy (DMMO)

The scalpel is advanced at an oblique angle of about 45° until it reaches the dorsal aspect of the distal metatarsal bone to undergo osteotomy. First a bone rasp specific for percutaneous surgery is used to separate the periosteum at the level of the osteotomy site. A Shannon Isham burr is introduced until it reaches the metatarsal neck where the periosteum was previously removed. Fluoroscopy is used to confirm the correct position of the osteotomy site. The lateral cortical surface is cut first, then the plantar, medial, and lastly, the dorsal cortical surface. During the osteotomy process, the incision site is irrigated by normal saline, as the burr can cause excessive heat, causing skin burn and resulting subsequently in fibrosis and pseudoarthrosis at the bone level.

Intervention Type: PROCEDURE

Other Intervention Names

DMMO PERCUTANEOUS SURGERY

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Carlo Biz

Orthopedic surgeon, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Biz, MD

Role: PRINCIPAL_INVESTIGATOR

Padua University Orthopaedic Clinic

Locations

Padua Univeristy Orthopaedic Clinic

Padua, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

CARLO BIZ, MD

Role: CONTACT

carlo.biz@unipd.it

00393483608819

LODOVICA GAMBATO, DR

Role: CONTACT

lodovica.gambato@aopd.veneto.it

00390498212342

Facility Contacts

Carlo Biz, MD

Role: primary

carlo.biz@unipd.it

00393483608819

Other Identifiers

4064/AO/17

Identifier Type: -

Identifier Source: org_study_id