Randomized control trial about two diferent approaches of the Scarf technique to treat hallux valgus: the classical open and the minimally invasive
| ISRCTN | ISRCTN13631918 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13631918 |
| Secondary identifying numbers | IRB number 10.04.2017 |
- Submission date
- 14/11/2020
- Registration date
- 20/11/2020
- Last edited
- 02/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Dr Robert Street, 5
Terrassa
08772
Spain
 ORCID ID |
0000-0002-3214-2439 |
|---|---|
| Phone | +34 (0)937350505 |
| jtorrent@mutuaterrassa.es |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Open versus minimally invasive Scarf osteotomy for hallux valgus correction. A randomized controlled study |
| Study objectives | The minimally invasive scarf technique provides a clinically and radiologically equivalent outcome to open scarf for the treatment of hallux valgus deformity. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2017 |
| Completion date | 01/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 32 |
| Total final enrolment | 58 |
| Key inclusion criteria | Patients undergoing hallux valgus surgery |
| Key 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 |
| Date of first enrolment | 10/10/2017 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- Spain
Study participating centre
Terrassa
08772
Spain
Sponsor information
Hospital/treatment centre
Dr Robert 5
Terrassa
08772
Spain
| Phone | +34 (0)937350505 |
|---|---|
| josep@torrentmail.net | |
| Website | http://www.mutuaterrassa.cat/ |
"ROR" |
https://ror.org/011335j04 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 18/11/2020 | 02/12/2020 | No | No |
Additional files
- ISRCTN13631918_BasicResults_18Nov2020.pdf
- Uploaded 02/12/2020
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.
