Quantification and Characterization of Foot Postoperative Edema

NCT ID: NCT05190835

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2023-11-15

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.

Conditions

Surgery--Complications

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Hallux surgery

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

Group Type: OTHER

Optical scanner

Intervention Type: DEVICE

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.

Metatarsal paddle surgery

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

Group Type: OTHER

Optical scanner

Intervention Type: DEVICE

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.

Hallux and metatarsal pallet surgery

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

Group Type: OTHER

Optical scanner

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique MEGIVAL

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Polyclinique Saint Roch

Montpellier, , France

Clinique MEGIVAL

Saint-Aubin-sur-Scie, , France

Countries

France

Other Identifiers

2021-A01802-39

Identifier Type: -

Identifier Source: org_study_id