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

Sponsor

University of Padova (Other)

Overall Status

Unknown status

CT.gov ID

NCT03639103

Collaborator

(none)

200

Enrollment

Location

156

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metatarsalgia Bilateral	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Actual Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 31, 2013

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

Evaluation of the 100-point hallux metatarsophalangeal-interphalangeal scale (AOFAS) changes [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.
Evaluation of the Foot Functional Index changes [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 [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.

Secondary Outcome Measures

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)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Padua Univeristy Orthopaedic Clinic	Padova		Italy	35128

Sponsors and Collaborators

University of Padova

Investigators

Principal Investigator: Carlo Biz, MD, Padua University Orthopaedic Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carlo Biz, Orthopedic surgeon, Assistant Professor, University of Padova

ClinicalTrials.gov Identifier:

NCT03639103

Other Study ID Numbers:

4064/AO/17

First Posted:

Aug 20, 2018

Last Update Posted:

Aug 20, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metatarsalgia

Study Results

No Results Posted as of Aug 20, 2018