Medium-Long-Term Clinical and Radiographic Outcomes of Minimally Invasive Distal Metatarsal Metaphyseal Osteotomy for Central Primary Metatarsalgia and Predictive Value of Maestro Criteria
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metatarsalgia Bilateral
- Sponsor
- University of Padova
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Evaluation of the Foot Functional Index changes
- Last Updated
- 7 years ago
Overview
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).
Investigators
Carlo Biz
Orthopedic surgeon, Assistant Professor
University of Padova
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.
Outcomes
Primary Outcomes
Evaluation of the Foot Functional Index changes
Time Frame: preoperatively, 3-, 6-, 12-months
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.
Evalutation of the Manchester-Oxford Foot Questionnaire changes
Time Frame: preoperatively, 3-, 6-, 12-months
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.
Evaluation of the 100-point hallux metatarsophalangeal-interphalangeal scale (AOFAS) changes
Time Frame: preoperatively, 3-, 6-, 12-months
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.
Secondary Outcomes
- Radiographic classification according to Maestro and Besse criteria(before surgery, at one-month after surgery and at different follow-ups (3-, 6-, 12-month, and last))