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TerminatedNCT04823169BAROCUpdated Jul 1, 2026

Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method

An interventional study of podobarometry in Distal Metatarsal Mini-invasive Osteotomy (DMMO), sponsored by Centre Hospitalier le Mans. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Centre Hospitalier le Mans · Not applicable, Interventional, and Other

Why this study was terminated
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.
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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). 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)

02

Conditions studied

  • Distal Metatarsal Mini-invasive Osteotomy (DMMO)

Keywords

  • Distal Metatarsal Mini-invasive Osteotomy
  • DMMO
  • Podobarometry
03

In context

Lead sponsor

Centre Hospitalier le Mans is the lead sponsor of 42 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    podobarometry

    podobarometric measures at day7 and day 30

    Other: podobarometry

Interventions

  • Otherpodobarometry

    podobarometric measures on day 7 and day 30

06

What researchers measure

Primary outcomes

  1. podobarographic parameters (plantar pressures) predictive of the need for a palliative foot orthosis

    Plantar pressures were measured by podobarometric Platform (FREEMED Platform)

    Time frame: 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

    Time frame: 90 days after surgery

07

Study locations

1 site
  • Centre Hospitalier Du Mans
    Le Mans, 72000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04823169
Lead sponsor
Centre Hospitalier le Mans
Responsible party
Sponsor
First posted
Mar 30, 2021
Start date
Sep 14, 2022
Primary completion
Sep 1, 2024
Completion
Sep 1, 2024
Last update
Jul 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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