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

Medium-Long-Term Clinical and Radiographic Outcomes of Minimally Invasive Distal Metatarsal Metaphyseal Osteotomy for Central Primary Metatarsalgia and Predictive Value of Maestro Criteria

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.

Study Overview

• Status: Unknown
• Conditions: Metatarsalgia Bilateral
• Intervention / Treatment: Procedure: Distal Metatarsal Metaphyseal Osteotomy (DMMO)

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).

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35128
    • Recruiting
    • Padua Univeristy Orthopaedic Clinic
    • Contact: Carlo Biz, MD; Phone Number: 00393483608819; Email: carlo.biz@unipd.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the 100-point hallux metatarsophalangeal-interphalangeal scale (AOFAS) changes	The AOFAS score includes 9 questions related to pain, function and alignment; a score of 90-100 is considered excellent; 75-89 as good; 50-74 as fair and less than 49 points is considered a failure or a poor outcome.	preoperatively, 3-, 6-, 12-months
Evaluation of the Foot Functional Index changes	The Foot Functional Index to measure the persistence of pain, disability, and restriction of activity with 17 number rating scales from 0 to 10. The maximum score is 100, which indicates complete disability.	preoperatively, 3-, 6-, 12-months
Evalutation of the Manchester-Oxford Foot Questionnaire changes	The Manchester-Oxford Foot Questionnaire to establish how frequent the restrictions in specific situations were, including 16 questions divided into three basic domains: pain (five), walking/standing (seven), and social interaction (four). Scores for each domain are calculated by summing the responses to each item within a given domain. Raw scores can be converted to a 0-100 metric where 100=most severe.	preoperatively, 3-, 6-, 12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic classification according to Maestro and Besse criteria	Our sample is classified radiographically according to Maestro and Besse criteria, adding to this classification one more group to include those feet that did not reflect any morphotype as defined by Maestro parameters. The radiographic evaluations includes the Maestro criteria index using the preoperative and the last follow up. The relative length of each metatarsal is determined by drawing a line perpendicular to the axis of the foot and then measuring the distances (in millimeters) from each metatarsal head to this line , while also taking into account the relationship between the length of metatarsal M1 and the length of the remaining metatarsal bones.	before surgery, at one-month after surgery and at different follow-ups (3-, 6-, 12-month, and last)

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Carlo Biz, MD, Padua University Orthopaedic Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): December 31, 2013
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Foot Diseases; Joint Diseases; Musculoskeletal Diseases; Metatarsalgia
• Other Study ID Numbers: 4064/AO/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No