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

H

Hospital Mutua de Terrassa

Status

Unknown

Conditions

Hallux Valgus and Bunion (Disorder)

Treatments

Procedure: Minimally invasive scarf Osteotomy
Procedure: Open Scarf Osteotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03575338
Hospital Mútua Terrassa

Details and patient eligibility

About

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.

Full description

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.

Enrollment

86 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

86 participants in 2 patient groups

Open Scarf Osteotomy
Active Comparator group
Description:
This group of patients will undergo surgery performing an open scarf osteotomy
Treatment:
Procedure: Open Scarf Osteotomy
Minimally invasive scarf Osteotomy
Experimental group
Description:
This group of patients will undergo surgery performing a Minimally invasive scarf osteotomy
Treatment:
Procedure: Minimally invasive scarf Osteotomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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