Pilot Study of Percutaneous Correction of Hallux Valgus | NCT05880407

Studies
Pilot Study of Percutaneous Correction of Hallux Valgus

NCT05880407

Sponsor

Istituto Ortopedico Rizzoli

Status

Recruiting

Last Update Posted

May 4, 2026Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Hallux Valgus

Interventions

SERI osteotomy
percutaneous osteotomy according to Chevron

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2022Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Feb 1, 2023

First Submission Date that Met QC Criteria

May 19, 2023

First Posted Date

May 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2026

Last Update Posted Date

May 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
standard treatment	Active Comparator	SERI osteotomy	Procedure: SERI osteotomy
experimental treatment	Experimental	percutaneous osteotomy according to Chevron	Procedure: percutaneous osteotomy according to Chevron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SERI osteotomy	Procedure	Correction of varus deformity of the 1st Metatarsal that is stabilized with Kirschnner wire	standard treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analog Score	pain visual analog assessment	baseline
Visual Analog Score	pain visual analog assessment	1 year

Secondary Outcomes

Measure	Description	Time Frame
American Orhtopaedic Foot and Ankle Society forefoot score	range of motion evaluation	baseline and aftef 1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lisa Berti, MD	Contact	051.63.66	571	lisa.berti@ior.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Ortopedico Rizzoli	Recruiting	Bologna		40136	Italy

Condition Browse Module

MeSH Terms

ID	Term
D006215	Hallux Valgus

Ancestor Terms

ID	Term
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided