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Clinical Trials/NCT04174482
NCT04174482
Completed
Not Applicable

Pilot Study of Morphological and Functional Evaluation of Adult Flat Foot by Weight Bearing CT and Gait Analysis Before and After Corrective Surgery

Istituto Ortopedico Rizzoli1 site in 1 country16 target enrollmentDecember 3, 2018
ConditionsFlat Feet

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Flat Feet
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
16
Locations
1
Primary Endpoint
Weight bearing computed tomography parameter
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Morphological weight bearing computed tomography parameters and gait analysis can implement the evaluation of the flat foot. Weight bearing CT is useful to verify the severity of the 3D deformities typical of flat foot, while kinematic and kinetic variables of gait is able to quantify the functional improvements of the foot after surgery.

Registry
clinicaltrials.gov
Start Date
December 3, 2018
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients with idiopathic flat foot with indication for corrective surgical treatment according to Grice (arthrodesis of the subtalar joint)
  • age between 18 and 65 years
  • BMI less than 40
  • signature of informed consent.

Exclusion Criteria

  • patients with severe alterations or other pathologies affecting the foot and lower limb
  • severe vascular and neurological systemic diseases
  • systemic diseases that can compromise bone consolidation

Outcomes

Primary Outcomes

Weight bearing computed tomography parameter

Time Frame: change from baseline at 6-months

calcaneal pitch angle (degree)

Gait Analysis parameter

Time Frame: change from baseline at 6-months

medial longitudinal arch

Secondary Outcomes

  • Pain clinical examination parameter(pre-operative phase and at a 6-months follow-up from the intervention)
  • Function clinical examination parameter(pre-operative phase and at a 6-months follow-up from the intervention)
  • Posture clinical examination parameter(pre-operative phase and at a 6-months follow-up from the intervention)

Study Sites (1)

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