MedTrace Logo

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

NCT03639103 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2018-08-20

No results posted yet for this study

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.

Conditions

  • Metatarsalgia Bilateral

Interventions

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.

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Carlo Biz, MD · Padua University Orthopaedic Clinic

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-01
Primary Completion
2013-12-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03639103 on ClinicalTrials.gov