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

Metatarsalgia Bilateral Clinical Trial

— DMMO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03639103
• Other study ID #: 4064/AO/17
• Status: Recruiting
• Start date: January 1, 2009
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2018
• Source: University of Padua
• Contact: CARLO BIZ, MD
• Phone: 00393483608819
• Email: carlo.biz[@]unipd.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metatarsalgia
• Metatarsalgia Bilateral

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Italy	Padua Univeristy Orthopaedic Clinic	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padua

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)