Quantification and Characterization of Foot Postoperative Edema

Quantification and Characterization of Foot Postoperative Edema - Bicentric Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Surgery--Complications
• Intervention / Treatment: Device: Optical scanner

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34070
    • Polyclinique Saint Roch
  • Saint-Aubin-sur-Scie, France, 76550
    • Clinique Mégival

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hallux surgery; These are patients operated on for hallux without change of strategy compared to current care	Device: Optical scanner; 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.
Other: Metatarsal paddle surgery; These are patients operated on for metatarsal paddle without change of strategy compared to current care	Device: Optical scanner; 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.
Other: Hallux and metatarsal pallet surgery; These are patients operated on for hallux and metatarsal paddle without change of strategy compared to current care	Device: Optical scanner; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Clinique MEGIVAL

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): October 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2021-A01802-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No