Quantification and Characterization of Foot Postoperative Edema

NCT05190835 | Completed

• 1 other identifier: 2021-A01802-39
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Hallux surgery

OTHER

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

Device: Optical scanner

Metatarsal paddle surgery

OTHER

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

Device: Optical scanner

Hallux and metatarsal pallet surgery

OTHER

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

Device: Optical scanner

Interventions

Optical scanner 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; Hallux surgery; Metatarsal paddle surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Vulnerable people according to article L1121-6 of the CSP

Sponsors & Collaborators

• Clinique MEGIVAL: lead

Study Sites (2)

Polyclinique Saint Roch

Montpellier, 34070, France

Location

Clinique MEGIVAL

Saint-Aubin-sur-Scie, 76550, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 13, 2022
• Study Start: January 15, 2022
• Primary Completion: October 15, 2023
• Study Completion: November 15, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

FR (2)