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Pilot Study of Percutaneous Correction of Hallux Valgus (hallux valgus)

Primary Purpose

Hallux Valgus

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SERI osteotomy
percutaneous osteotomy according to Chevron
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients of both sexes with adult hallux valgus with indication for corrective surgical treatment HVA (hallux valgus angle): 20°-40° IMA (intermetatarsal angle): 10°-20° Exclusion Criteria: Patients with instability of the first metatarsophalangeal joint Patients with severe morphostructural alterations or other pathologies in the foot and lower limb patients requiring additional surgical procedures patients with severe vascular and neurological systemic pathologies systemic pathologies that may impair bone consolidation

Sites / Locations

  • Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

standard treatment

experimental treatment

Arm Description

SERI osteotomy

percutaneous osteotomy according to Chevron

Outcomes

Primary Outcome Measures

Visual Analog Score
pain visual analog assessment
Visual Analog Score
pain visual analog assessment

Secondary Outcome Measures

American Orhtopaedic Foot and Ankle Society forefoot score
range of motion evaluation

Full Information

First Posted
February 1, 2023
Last Updated
May 19, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT05880407
Brief Title
Pilot Study of Percutaneous Correction of Hallux Valgus
Acronym
hallux valgus
Official Title
Pilot Study of Percutaneous Correction of Hallux Valgus: Clinical-functional Evaluation of Outcome Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
This is a pilot study with a randomized controlled design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard treatment
Arm Type
Active Comparator
Arm Description
SERI osteotomy
Arm Title
experimental treatment
Arm Type
Experimental
Arm Description
percutaneous osteotomy according to Chevron
Intervention Type
Procedure
Intervention Name(s)
SERI osteotomy
Intervention Description
Correction of varus deformity of the 1st Metatarsal that is stabilized with Kirschnner wire
Intervention Type
Procedure
Intervention Name(s)
percutaneous osteotomy according to Chevron
Intervention Description
Correction of varus deformity by osteotomy stabilization with 2 screws inserted via dorsal percutaneous accesses to the 1st Metatarsal.
Primary Outcome Measure Information:
Title
Visual Analog Score
Description
pain visual analog assessment
Time Frame
baseline
Title
Visual Analog Score
Description
pain visual analog assessment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
American Orhtopaedic Foot and Ankle Society forefoot score
Description
range of motion evaluation
Time Frame
baseline and aftef 1 year

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 of both sexes with adult hallux valgus with indication for corrective surgical treatment HVA (hallux valgus angle): 20°-40° IMA (intermetatarsal angle): 10°-20° Exclusion Criteria: Patients with instability of the first metatarsophalangeal joint Patients with severe morphostructural alterations or other pathologies in the foot and lower limb patients requiring additional surgical procedures patients with severe vascular and neurological systemic pathologies systemic pathologies that may impair bone consolidation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Berti, MD
Phone
051.63.66
Ext
571
Email
lisa.berti@ior.it
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Berti, MD
Phone
051.63.66
Ext
571
Email
lisa.berti@ior.it

12. IPD Sharing Statement

Learn more about this trial

Pilot Study of Percutaneous Correction of Hallux Valgus

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