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

Not Applicable

• Conditions: Hallux Valgus and Bunion (Disorder)
• Interventions: Procedure: Minimally invasive scarf Osteotomy; Procedure: Open Scarf Osteotomy

• Registration Number: NCT03575338
• Lead Sponsor: Hospital Mutua de Terrassa

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2018-06
• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-06-29
• Last Update Submitted: 2018-06-29
• Study First Posted: 2018-07-02
• Last Update Posted: 2018-07-02
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minimally invasive scarf Osteotomy	Minimally invasive scarf Osteotomy	This group of patients will undergo surgery performing a Minimally invasive scarf osteotomy
Open Scarf Osteotomy	Open Scarf Osteotomy	This group of patients will undergo surgery performing an open scarf osteotomy

Primary Outcome Measures

Name	Time	Method
Hallux valgus angle postoperative	1 year - 2 years	The angle among the first metatarsal and the first phalanx

Secondary Outcome Measures

Name	Time	Method
First metatarso-phalangeal range of movement	1 year - 2 years	The range of movement of the first metatarso-phalangeal joint
Irradiation	Measurement during the surgery	The records of the radiation during the surgeries
Intermetatarsal 1-2 angle	1 year - 2 years	The angle among the 1st and the 2nd metatarsal
Surgery duration	Measurement during the surgery	The records of the surgery duration

Trial Locations

Locations (1)

Josep Torrent; 🇪🇸 Terrassa, Barcelona, Spain