Flat Feet Clinical Trial
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
Verified date | November 2019 |
Source | Istituto Ortopedico Rizzoli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Ortopedico Rizzoli | Bologna |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli |
Italy,
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. Epu — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight bearing computed tomography parameter | calcaneal pitch angle (degree) | change from baseline at 6-months | |
Primary | Gait Analysis parameter | medial longitudinal arch | change from baseline at 6-months | |
Secondary | Pain clinical examination parameter | visual analogue scale of the foot | pre-operative phase and at a 6-months follow-up from the intervention | |
Secondary | Posture clinical examination parameter | Foot Posture Index | pre-operative phase and at a 6-months follow-up from the intervention | |
Secondary | Function clinical examination parameter | Foot function Index | pre-operative phase and at a 6-months follow-up from the intervention |
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