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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03575338
Other study ID # Hospital Mútua Terrassa
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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 >20ยบ

- 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


Related Conditions & MeSH terms


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
See also
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