Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-09-01

Brief Summary

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The purpose of this study was to compare a minimally invasive scarf technique and the well-established open scarf technique for correction of hallux valgus deformity.

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Detailed Description

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Hallux valgus surgery is a common procedure being the open scarf osteotomy, one of the most studied techniques for correction of the hallux valgus. It is widely reported its capacity to reduce the angle of the first metatarso-phalangeal joint.

Minimally invasive scarf (MIS) technique has been designed to decrease the soft tissue damage and postoperative pain. This procedure does not require ischemia, being able to do under local anesthesia and sedation. This technique is more suitable for outpatient surgery.

There is a lack of studies comparing both techniques, and our purpose is to do a prospective comparative study among the two approaches of the scarf osteotomy: open vs MIS.

Conditions

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Hallux Valgus and Bunion (Disorder)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcomes assessor will not know the technique

Study Groups

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Open Scarf Osteotomy

This group of patients will undergo surgery performing an open scarf osteotomy

Group Type ACTIVE_COMPARATOR

Open Scarf Osteotomy

Intervention Type PROCEDURE

Open Scarf Osteotomy

Minimally invasive scarf Osteotomy

This group of patients will undergo surgery performing a Minimally invasive scarf osteotomy

Group Type EXPERIMENTAL

Minimally invasive scarf Osteotomy

Intervention Type PROCEDURE

Minimally invasive scarf Osteotomy

Interventions

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Open Scarf Osteotomy

Intervention Type PROCEDURE

Minimally invasive scarf Osteotomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- Patients undergo hallux valgus surgery

Exclusion Criteria

* Intermetatarsal angle \>20º
* Previous hallux valgus surgery
* Metatarsalgia of the lesser rays that requires an osteotomy during the surgical procedure
* 1st cuneometatarsal instability
* Infection
* Vascular ischemia
* Neuropathy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No