Medium-Long-Term Clinical and Radiographic Outcomes of Minimally Invasive Distal Metatarsal Metaphyseal Osteotomy for Central Primary Metatarsalgia and Predictive Value of Maestro Criteria
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluation of the Foot Functional Index changes
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •forefoot persistent pain;
- •presence or not of forefoot plantar hyperkeratosis lesions;
- •ineffective conservative and orthotic treatment performed for at least 6 months.
排除标准
- •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.
结局指标
主要结局
Evaluation of the Foot Functional Index changes
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
研究者
Carlo Biz
Orthopedic surgeon, Assistant Professor
University of Padova