Condition category
Musculoskeletal Diseases
Date applied
14/11/2020
Date assigned
20/11/2020
Last edited
02/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

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. jtorrent@mutuaterrassa.es

Trial website

Contact information

Type

Scientific

Primary contact

Mr Josep Torrent

ORCID ID

http://orcid.org/0000-0002-3214-2439

Contact details

Dr Robert Street
5
Terrassa
08772
Spain
+34 (0)937350505
jtorrent@mutuaterrassa.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRB number 10.04.2017

Study information

Scientific title

Open versus minimally invasive Scarf osteotomy for hallux valgus correction. A randomized controlled study

Acronym

Study hypothesis

The minimally invasive scarf technique provides a clinically and radiologically equivalent outcome to open scarf for the treatment of hallux valgus deformity.

Ethics approval

Approved 04/10/2017, Ethics Comitee Hospital Universitari Mútua de Terrassa (Dr Robert St number 5, 08772, Terrassa (Barcelona), Spain; +34 937365050; ceim@mutuaterrassa.cat), ref: 10.04.2017

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet.

Condition

Hallux valgus

Intervention

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.

Intervention type

Procedure/Surgery

Phase

Drug names

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

01/01/2017

Overall trial end date

01/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients undergoing hallux valgus surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32

Total final enrolment

58

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
5. Infection
6. Vascular ischemia
7. Neuropathy

Recruitment start date

10/10/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Universitari Mutua de Terrassa
Dr Robert St, 5
Terrassa
08772
Spain

Sponsor information

Organisation

University Hospital Mútua de Terrassa

Sponsor details

Dr Robert 5
Terrassa
08772
Spain
+34 (0)937350505
josep@torrentmail.net

Sponsor type

Hospital/treatment centre

Website

http://www.mutuaterrassa.cat/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Mútua de Terrassa

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

31/12/2020

Participant level data

Available on request

Basic results (scientific)

See additional file ISRCTN13631918_BasicResults_18Nov2020 (added 02/12/2020)

Publication list

Publication citations

Additional files

Editorial Notes

02/12/2020: The basic results of this trial have been uploaded as an additional file. 18/11/2020: Trial’s existence confirmed by Ethics Committee Hospital Universitari Mútua de Terrassa.