Quantification and Characterization of Foot Postoperative Edema

Clinique MEGIVAL

Status: Completed

Conditions: Surgery--Complications

Treatments: Device: Optical scanner

Study type: Interventional

Funder types: Other

Identifiers

NCT05190835

2021-A01802-39

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Hallux surgery

Other group

Description:

These are patients operated on for hallux without change of strategy compared to current care

Treatment:

Device: Optical scanner

Metatarsal paddle surgery

Other group

Description:

These are patients operated on for metatarsal paddle without change of strategy compared to current care

Treatment:

Device: Optical scanner

Hallux and metatarsal pallet surgery

Other group

Description:

These are patients operated on for hallux and metatarsal paddle without change of strategy compared to current care

Treatment:

Device: Optical scanner