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Pilot Study of Percutaneous Correction of Hallux Valgus

ConditionHallux Valgus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstituto Ortopedico Rizzoli

About this trial

This is a pilot study with a randomized controlled design.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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°

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SERI osteotomy

    Procedure/Surgery

    Correction of varus deformity of the 1st Metatarsal that is stabilized with Kirschnner wire

  • percutaneous osteotomy according to Chevron

    Procedure/Surgery

    Correction of varus deformity by osteotomy stabilization with 2 screws inserted via dorsal percutaneous accesses to the 1st Metatarsal.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: standard treatmentActive comparator 1 intervention
Group B: experimental treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Visual Analog Score

pain visual analog assessment

Time frame
baseline
2

Visual Analog Score

pain visual analog assessment

Time frame
1 year

Secondary outcomes

1

American Orhtopaedic Foot and Ankle Society forefoot score

range of motion evaluation

Time frame
baseline and aftef 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Ortopedico Rizzoli

Lead sponsor

Source ClinicalTrials.gov
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