Distal Metatarsal Mini-invasive Osteotomy (DMMO)BAROCNCT04823169
Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method
A study testing podobarometry in people with Distal Metatarsal Mini-invasive Osteotomy (DMMO), run by Centre Hospitalier le Mans at 1 site in France.
Trial summary
The definitive treatment of disabling metatarsalgia requires surgery. In recent years, a percutaneous technique has been developed, the "Distal Metatarsal Mini-invasive Osteotomy" (DMMO). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Metatarsal Mini-invasive Osteotomy (DMMO)
- What is being tested?
- podobarometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2022to 1 Sep 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult person
- Affiliated or beneficiary of a statutory social insurance scheme
- Free ans informed consent
- Following foot surgery like DMMO only or DMMO and hallux valgus
Who cannot join
- Minor or legally protect adult
- Amputation disturbing the natural course of the step
- Osteoarticular diseases/sequelae affecting walking and/or balance
- Neuromuscular diseases/sequelae affecting walking and/or balance
- Vestibular disorders affecting balance
- Patients requiring a walking aid (e.g., walker)
- Pregnant woman
- Patient with dementia who are unable to follow verbal instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method.
The definitive treatment of disabling metatarsalgia requires surgery. In recent years, a percutaneous technique has been developed, the "Distal Metatarsal Mini-invasive Osteotomy" (DMMO). It consists of performing extra-articular osteotomies that are not osteosynthesized and maintained during the time of bone consolidation by a dressing and specific offloading footwear.The patient is encouraged to resume walking immediately after the procedure, as full plantar support is an integral part of the surgical concept. The goal is to actively modify the distribution of all metatarsal supports by the pressure exerted on the ground during walking and by tendon tensions, in order to reduce forefoot deformities.
DMMO offers many advantages over traditional techniques, but it remains a painful forefoot surgery in the short term despite the systematic use of analgesics and the wearing of a dedicated therapeutic shoe.
The study will seek to identify the predictive character of podobarometric parameters at walking (D+7 and D+30 post-op), between patients who will require a palliative solution versus those who will not (D+90)
- Being tested
- podobarometry
- Keywords
- Distal Metatarsal Mini-invasive Osteotomy, DMMO, Podobarometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
podobarometryOther
podobarometric measures on day 7 and day 30
| Study group | Role | What they receive |
|---|---|---|
| podobarometry | Experimental | podobarometric measures at day7 and day 30 Receives: Other: podobarometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
podobarographic parameters (plantar pressures) predictive of the need for a palliative foot orthosis
Plantar pressures were measured by podobarometric Platform (FREEMED Platform)
Measured: 90 days after surgery
Secondary outcomes (1)
Compare daily walk pain kinetics over one month postoperatively in patients requesting palliative solutions at 3 months (requesters) versus those not requesting them (non-requesters)
Daily walk pain was measured by questionnaire (Google form) completed by patient every day during 30 days
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start14 Sep 2022
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Why it stopped: The reorganization of the department and the principal investigator's retirement halted patient enrollment in this study. Only 4 patients were enrolled, which made it impossible to meet the primary objective.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Metatarsal Mini-invasive Osteotomy (DMMO)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823169
- Sponsor's protocol ID
- CHM-2020/S11/09
- Acronym
- BAROC
- Status last verified
- Jun 2026
- First submitted
- 25 Mar 2021
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method.
- ClinicalTrials.gov ID
- NCT04823169
- Acronym / sponsor ID
- BAROC / CHM-2020/S11/09
- Keywords
- Distal Metatarsal Mini-invasive Osteotomy, DMMO, Podobarometry
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The reorganization of the department and the principal investigator's retirement halted patient enrollment in this study. Only 4 patients were enrolled, which made it impossible to meet the primary objective.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 30 Mar 2021 (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 definitive treatment of disabling metatarsalgia requires surgery. In recent years, a percutaneous technique has been developed, the "Distal Metatarsal Mini-invasive Osteotomy" (DMMO). It consists of performing extra-articular osteotomies that are not osteosynthesized and maintained during the time of bone consolidation by a dressing and specific offloading footwear.The patient is encouraged to resume walking immediately after the procedure, as full plantar support is an integral part of the surgical concept. The goal is to actively modify the distribution of all metatarsal supports by the pressure exerted on the ground during walking and by tendon tensions, in order to reduce forefoot deformities.
DMMO offers many advantages over traditional techniques, but it remains a painful forefoot surgery in the short term despite the systematic use of analgesics and the wearing of a dedicated therapeutic shoe.
The study will seek to identify the predictive character of podobarometric parameters at walking (D+7 and D+30 post-op), between patients who will require a palliative solution versus those who will not (D+90)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| podobarometry | Experimental | Other: podobarometrypodobarometric measures at day7 and day 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult person
- Affiliated or beneficiary of a statutory social insurance scheme
- Free ans informed consent
- Following foot surgery like DMMO only or DMMO and hallux valgus
Key exclusion criteria (8 listed)
- Minor or legally protect adult
- Amputation disturbing the natural course of the step
- Osteoarticular diseases/sequelae affecting walking and/or balance
- Neuromuscular diseases/sequelae affecting walking and/or balance
- Vestibular disorders affecting balance
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 |
|---|---|---|
| podobarometrypodobarometric measures on day 7 and day 30 | Other | podobarometry |
Primary outcome
podobarographic parameters (plantar pressures) predictive of the need for a palliative foot orthosis
Time frame: 90 days after surgery
Plantar pressures were measured by podobarometric Platform (FREEMED Platform)
1 secondary outcome
Compare daily walk pain kinetics over one month postoperatively in patients requesting palliative solutions at 3 months (requesters) versus those not requesting them (non-requesters)
Time frame: 90 days after surgery
Results and safety
The study was stopped early (reason given: The reorganization of the department and the principal investigator's retirement halted patient enrollment in this study. Only 4 patients were enrolled, which made it impossible to meet the primary objective.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing podobarometry in people with Distal Metatarsal Mini-invasive Osteotomy (DMMO), run by Centre Hospitalier le Mans at 1 site in France.
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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 1 Jul 2026. 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 France. 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?
The study was stopped early (reason given: The reorganization of the department and the principal investigator's retirement halted patient enrollment in this study. Only 4 patients were enrolled, which made it impossible to meet the primary objective.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
podobarographic parameters (plantar pressures) predictive of the need for a palliative foot orthosis (time frame: 90 days after surgery). 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 1 Jul 2026.