Back to resultsMorphological and Functional Evaluation of Adult Flat Foot Before and After Corrective Surgery
Primary Purpose
Flat Feet
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
morphological and functional evaluation of adult flat foot
Sponsored by
About this trial
This is an interventional treatment trial for Flat Feet
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
Sites / Locations
- Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
flat foot patients
Arm Description
20 patients recruited consecutively and candidates for surgery to correct the adult flat foot according to the Grice technique.
Outcomes
Primary Outcome Measures
Weight bearing computed tomography parameter
calcaneal pitch angle (degree)
Gait Analysis parameter
medial longitudinal arch
Secondary Outcome Measures
Pain clinical examination parameter
visual analogue scale of the foot
Posture clinical examination parameter
Foot Posture Index
Function clinical examination parameter
Foot function Index
Full Information
NCT ID
NCT04174482
First Posted
November 18, 2019
Last Updated
February 1, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT04174482
Brief Title
Morphological and Functional Evaluation of Adult Flat Foot Before and After Corrective Surgery
Official Title
Pilot Study of Morphological and Functional Evaluation of Adult Flat Foot by Weight Bearing CT and Gait Analysis Before and After Corrective Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
December 3, 2020 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flat Feet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
flat foot patients
Arm Type
Experimental
Arm Description
20 patients recruited consecutively and candidates for surgery to correct the adult flat foot according to the Grice technique.
Intervention Type
Procedure
Intervention Name(s)
morphological and functional evaluation of adult flat foot
Intervention Description
Evaluations are realized by weight bearing computed tomography and by Gait analysis in the pre-operative phase and at a 6-months follow-up from the surgery with Grice technique
Primary Outcome Measure Information:
Title
Weight bearing computed tomography parameter
Description
calcaneal pitch angle (degree)
Time Frame
change from baseline at 6-months
Title
Gait Analysis parameter
Description
medial longitudinal arch
Time Frame
change from baseline at 6-months
Secondary Outcome Measure Information:
Title
Pain clinical examination parameter
Description
visual analogue scale of the foot
Time Frame
pre-operative phase and at a 6-months follow-up from the intervention
Title
Posture clinical examination parameter
Description
Foot Posture Index
Time Frame
pre-operative phase and at a 6-months follow-up from the intervention
Title
Function clinical examination parameter
Description
Foot function Index
Time Frame
pre-operative phase and at a 6-months follow-up from the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
27810020
Citation
Burssens A, Peeters J, Buedts K, Victor J, Vandeputte G. Measuring hindfoot alignment in weight bearing CT: A novel clinical relevant measurement method. Foot Ankle Surg. 2016 Dec;22(4):233-238. doi: 10.1016/j.fas.2015.10.002. Epub 2015 Oct 30.
Results Reference
result
PubMed Identifier
25819716
Citation
Buldt AK, Levinger P, Murley GS, Menz HB, Nester CJ, Landorf KB. Foot posture is associated with kinematics of the foot during gait: A comparison of normal, planus and cavus feet. Gait Posture. 2015 Jun;42(1):42-8. doi: 10.1016/j.gaitpost.2015.03.004. Epub 2015 Mar 12.
Results Reference
result
PubMed Identifier
16965916
Citation
Leardini A, Benedetti MG, Berti L, Bettinelli D, Nativo R, Giannini S. Rear-foot, mid-foot and fore-foot motion during the stance phase of gait. Gait Posture. 2007 Mar;25(3):453-62. doi: 10.1016/j.gaitpost.2006.05.017. Epub 2006 Sep 11.
Results Reference
result
Learn more about this trial
Morphological and Functional Evaluation of Adult Flat Foot Before and After Corrective Surgery
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