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

Study Overview
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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.

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.

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

Conditions
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Hallux Valgus and Bunion (Disorder)

Intervention / Treatment
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* Procedure: Open Scarf Osteotomy
* Procedure: Minimally invasive scarf Osteotomy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open Scarf Osteotomy<br>This group of patients will undergo surgery performing an open scarf osteotomy | Procedure: Open Scarf Osteotomy<br>* Open Scarf Osteotomy<br>|
| Experimental: Minimally invasive scarf Osteotomy<br>This group of patients will undergo surgery performing a Minimally invasive scarf osteotomy | Procedure: Minimally invasive scarf Osteotomy<br>* Minimally invasive scarf Osteotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hallux valgus angle postoperative | The angle among the first metatarsal and the first phalanx | 1 year - 2 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scarf, minimally invasive surgery, hallux valgus