Quantification and Characterization of Foot Postoperative Edema

Not Applicable

Completed

• Conditions: Surgery--Complications
• Interventions: Device: Optical scanner

• Registration Number: NCT05190835
• Lead Sponsor: Clinique MEGIVAL

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-13
• Study Start: 2022-01-15
• Primary Completion: 2023-10-15
• Study Completion: 2023-11-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hallux surgery	Optical scanner	These are patients operated on for hallux without change of strategy compared to current care
Metatarsal paddle surgery	Optical scanner	These are patients operated on for metatarsal paddle without change of strategy compared to current care
Hallux and metatarsal pallet surgery	Optical scanner	These are patients operated on for hallux and metatarsal paddle without change of strategy compared to current care

Primary Outcome Measures

Name	Time	Method
Evaluate the change of volume of an operated foot to evaluate the edema.	Day 0 before surgery, Day 8 after surgery	Change of volume of the foot from Day 0
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

Trial Locations

Locations (2)

Clinique MEGIVAL; 🇫🇷 Saint-Aubin-sur-Scie, France

Polyclinique Saint Roch; 🇫🇷 Montpellier, France