Plain English Summary
Background and study aims
Hallux valgus is a common deformity that affects the first toe of the foot. The Scarf osteotomy is one of the surgical procedures to address the deformity and has shown excellent results. It was originally described as a first metatarsal osteotomy, with an open approach. To date, any of the Scarf variations have always involved open surgery and no minimally invasive (MI) adaptation has been described to the best of our knowledge. MI procedures have the theoretical advantages of faster recovery, reduced pain levels, less soft-tissue damage and reduced morbidity. We developed the minimally invasive technique to perform the Scarf procedure.
There are currently no available studies that report outcomes for MI Scarf osteotomy nor any comparison with open Scarf. The purpose of this prospective randomized study was to describe the MI scarf osteotomy and to evaluate its outcomes in comparison with the open Scarf osteotomy.
Who can participate?
All patients who will undergo hallux valgus surgery are eligible to participate in this study. There are some exceptions related to systemic diseases like infection or vascular ischemia.
What does the study involve?
All the patients have a symptomatic hallux valgus that requires a surgery. The chosen surgical procedure is a Scarf osteotomy as we perform in our hospital following our protocol. There are two different approaches that we use daily: open and minimally invasive. In a preliminary review we did not observe differences about results. If a patient participates in this study, will be randomised in two groups: open approach and minimally invasive approach. The postoperative controls will be as usual, and we will not perform extra x-ray explorations.
What are the possible benefits and risks of participating?
There are no benefits of participating. About the possible risks: both approaches have been used in our hospital for more than 10 years, we have not observed extra risks for using these two techniques.
Where is the study run from?
The study is run from the orthopaedics department of the Hospital universitari Mutua Terrassa
When is the study starting and how long is it expected to run for?
January 2017 to September 2019
Who is funding the study?
The Hospital Universitari Mutua Terrassa (Spain)
Who is the main contact?
Josep Torrent M.D. firstname.lastname@example.org
IRB number 10.04.2017
Open versus minimally invasive Scarf osteotomy for hallux valgus correction. A randomized controlled study
The minimally invasive scarf technique provides a clinically and radiologically equivalent outcome to open scarf for the treatment of hallux valgus deformity.
Approved 04/10/2017, Ethics Comitee Hospital Universitari Mútua de Terrassa (Dr Robert St number 5, 08772, Terrassa (Barcelona), Spain; +34 937365050; email@example.com), ref: 10.04.2017
Randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet.
Procedure A: Open Scarf Osteotomy
Procedure B: Minimally invasive scarf Osteotomy
All patients had initially undergone a 6-month period of conservative treatment that included shoe wear modification, interdigital orthosis, physiotherapy and non-steroidal anti-inflammatory drugs. Only after failing conservative treatment for at least 6 months, the patient was proposed for surgical intervention. Patients were then randomized into two groups using a system with envelopes that were selected at random from a box. The first group underwent minimally invasive scarf osteotomy (MI group), and the second open scarf osteotomy (open group). Patients were assigned to minimally invasive or open group by random selection.
The mean follow-up was 21 (range, 12 to 23) months.
Primary outcome measure
The angle among the 1st and the 2nd metatarsal bone of the foot measured using the digital sotware RaimJava® at 3-6-12 months.
Secondary outcome measures
Surgery duration measured using a stopwatch during the surgical procedure
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Patients undergoing hallux valgus surgery
Target number of participants
Total final enrolment
Participant exclusion criteria
1. Intermetatarsal angle >20º
2. Previous hallux valgus surgery
3. Metatarsalgia of the lesser rays that requires an osteotomy during the surgical procedure
4. 1st cuneometatarsal instability
6. Vascular ischemia
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Hospital Universitari Mutua de Terrassa
Dr Robert St, 5
University Hospital Mútua de Terrassa
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. All the data will be destroyed after the final follow-up of 5 years. The data will be analysed by the main investigator and shared to the statistical department of the hospital. We will not use the initials of the patient in the statistical study to preserve the anonymity. We obtained the consent of all the patients.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
See additional file ISRCTN13631918_BasicResults_18Nov2020 (added 02/12/2020)
- ISRCTN13631918_BasicResults_18Nov2020.pdf Uploaded 02/12/2020