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

Hallux Valgus and Bunion (Disorder) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03575338
• Other study ID #: Hospital Mútua Terrassa
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: June 2018
• Source: Hospital Mutua de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bunion
• Hallux Valgus
• Hallux Valgus and Bunion (Disorder)

Intervention

Procedure:
• Open Scarf Osteotomy
Open Scarf Osteotomy
• Minimally invasive scarf Osteotomy
Minimally invasive scarf Osteotomy

Locations

Country	Name	City	State
Spain	Josep Torrent	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Mutua de Terrassa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hallux valgus angle postoperative	The angle among the first metatarsal and the first phalanx	1 year - 2 years
Secondary	Intermetatarsal 1-2 angle	The angle among the 1st and the 2nd metatarsal	1 year - 2 years
Secondary	First metatarso-phalangeal range of movement	The range of movement of the first metatarso-phalangeal joint	1 year - 2 years
Secondary	Surgery duration	The records of the surgery duration	Measurement during the surgery
Secondary	Irradiation	The records of the radiation during the surgeries	Measurement during the surgery