Quantification and Characterization of Foot Postoperative Edema

Study Overview
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Brief Summary
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In foot surgery, postoperative edema is a complication making the postoperative outcome quite uncertain as to the rehabilitation of the patient. The evolution of this edema is unknown ... The means of mastering this edema are empirical, with little study other than cryotherapy and restraint. This study aims to study postoperative edema in a cohort of patients undergoing forefoot surgery. The follow-up will be prospective with measurement of the volume of the foot using an optical technique, during the various follow-up consultations between Day 8 and Month 6 postoperative.

Official Title
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Quantification and Characterization of Foot Postoperative Edema - Bicentric Prospective Study

Conditions
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Surgery--Complications

Intervention / Treatment
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* Device: Optical scanner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major patient Patient operated on forefoot surgery Patient having given informed consent For female patients of childbearing age, not to be pregnant or likely to be during the study, not to be breastfeeding Exclusion Criteria: Minor patient Patient deprived of his liberty or under guardianship Patient operated on for surgery of the forefoot other than hallux and lateral toes Patient unable to undergo protocol monitoring for psychological, social, family, geographic or linguistic reasons Patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic Vulnerable people according to article L1121-6 of the CSP

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hallux surgery<br>These are patients operated on for hallux without change of strategy compared to current care | Device: Optical scanner<br>* During the visits (Day 0 before surgery, Day 8, Day 21, Day 45, Month 3 and Month 6 after surgery), a measurement of the volume and the perimeter of the patient's two feet is carried out (operated foot and control foot). The edema is measured by a non-invasive method using an optical scanner (camera + laser scanning). The image processing software accompanying this tool has an automatic calculation of the volumes and the different perimeters of the foot. The measurement time by the scanner is less than 4 seconds.<br>|
| Other: Metatarsal paddle surgery<br>These are patients operated on for metatarsal paddle without change of strategy compared to current care | Device: Optical scanner<br>* During the visits (Day 0 before surgery, Day 8, Day 21, Day 45, Month 3 and Month 6 after surgery), a measurement of the volume and the perimeter of the patient's two feet is carried out (operated foot and control foot). The edema is measured by a non-invasive method using an optical scanner (camera + laser scanning). The image processing software accompanying this tool has an automatic calculation of the volumes and the different perimeters of the foot. The measurement time by the scanner is less than 4 seconds.<br>|
| Other: Hallux and metatarsal pallet surgery<br>These are patients operated on for hallux and metatarsal paddle without change of strategy compared to current care | Device: Optical scanner<br>* During the visits (Day 0 before surgery, Day 8, Day 21, Day 45, Month 3 and Month 6 after surgery), a measurement of the volume and the perimeter of the patient's two feet is carried out (operated foot and control foot). The edema is measured by a non-invasive method using an optical scanner (camera + laser scanning). The image processing software accompanying this tool has an automatic calculation of the volumes and the different perimeters of the foot. The measurement time by the scanner is less than 4 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the change of volume of an operated foot to evaluate the edema. | Change of volume of the foot from Day 0 | Day 0 before surgery, Day 8 after surgery | 
| Evaluate the change of volume of the edema of an operated foot during the 6 months after surgery |  | Day 21, Day 45, Month 3 and Month 6 after surgery |