Metatarsalgia BilateralDMMONCT03639103
Clinical and Radiographic Outcomes of Distal Metatarsal Metaphyseal Osteotomy for Central Primary Metatarsalgia
An observational study of Metatarsalgia Bilateral, run by University of Padova at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Metatarsalgia Bilateral
- What is being tested?
- Distal Metatarsal Metaphyseal Osteotomy (DMMO)
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2009to 31 Dec 2021
- How long will I take part?
- 12 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with diagnosis of central primary metatarsalgia between M2 and M4 of a biomechanical etiology in the plantar foot area are enrolled consecutively and prospectively with precise inclusion criteria. Ages range from 18 to 90 years.
Who may be able to join
- forefoot persistent pain;
- presence or not of forefoot plantar hyperkeratosis lesions;
- ineffective conservative and orthotic treatment performed for at least 6 months.
Who cannot join
- 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;
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- previous trauma;
- foot and ankle surgery,
- any form of secondary or iatrogenic metatarsalgia.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Padua Univeristy Orthopaedic Clinic
Padova, 35128
Carlo Biz, MD, 00393483608819, carlo.biz@unipd.it
About this study
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
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.
Read the 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).
- Conditions
- Metatarsalgia Bilateral
- Being tested
- Distal Metatarsal Metaphyseal Osteotomy (DMMO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal Metatarsal Metaphyseal Osteotomy (DMMO)Procedure or surgery
Also called DMMO PERCUTANEOUS SURGERY
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: preoperatively, 3-, 6-, 12-months
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.
Measured: preoperatively, 3-, 6-, 12-months
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.
Measured: preoperatively, 3-, 6-, 12-months
Secondary outcomes (1)
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.
Measured: before surgery, at one-month after surgery and at different follow-ups (3-, 6-, 12-month, and last)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Jan 2009
- Primary completion31 Dec 2013
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metatarsalgia BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Years
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Biz, University of Padova
- Investigators
- Carlo Biz, MD, Principal investigator, Padua University Orthopaedic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639103
- Sponsor's protocol ID
- 4064/AO/17
- Acronym
- DMMO
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2018
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03639103
- Acronym / sponsor ID
- DMMO / 4064/AO/17
- Conditions
- Metatarsalgia Bilateral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of central primary metatarsalgia between M2 and M4 of a biomechanical etiology in the plantar foot area are enrolled consecutively and prospectively with precise inclusion criteria. Ages range from 18 to 90 years.
Key inclusion criteria (3 listed)
- forefoot persistent pain;
- presence or not of forefoot plantar hyperkeratosis lesions;
- ineffective conservative and orthotic treatment performed for at least 6 months.
Key exclusion criteria (9 listed)
- arthritis and stiffness of MTP joint;
- congenital deformities of the foot;
- hallux rigidus;
- Freiberg infraction;
- Morton's neuroma;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal Metatarsal Metaphyseal Osteotomy (DMMO)Also: DMMO PERCUTANEOUS SURGERYThe 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. | Procedure or surgery | – |
Primary outcome
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.
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.
1 secondary outcome
Radiographic classification according to Maestro and Besse criteria
Time frame: before surgery, at one-month after surgery and at different follow-ups (3-, 6-, 12-month, and last)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo Biz, MD principal investigator
Padua University Orthopaedic Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metatarsalgia Bilateral, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CARLO BIZ, MD (00393483608819, carlo.biz@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the 100-point hallux metatarsophalangeal-interphalangeal scale (AOFAS) changes (time frame: preoperatively, 3-, 6-, 12-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.