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

June 29, 2018 updated by: josep torrent, Hospital Mutua de Terrassa
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Open Scarf Osteotomy
This group of patients will undergo surgery performing an open scarf osteotomy
Procedure: Open Scarf Osteotomy
Open Scarf Osteotomy
EXPERIMENTAL: Minimally invasive scarf Osteotomy
This group of patients will undergo surgery performing a Minimally invasive scarf osteotomy
Procedure: Minimally invasive scarf Osteotomy
Minimally invasive scarf Osteotomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Mutua de Terrassa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ANTICIPATED)

September 1, 2019

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

June 29, 2018

First Posted (ACTUAL)

July 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 29, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hospital Mútua Terrassa

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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