Hallux Valgus and Bunion (Disorder)NCT03575338
Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial
A study testing Open Scarf Osteotomy and Minimally invasive scarf Osteotomy in people with Hallux Valgus and Bunion (Disorder), run by Hospital Mutua de Terrassa at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus and Bunion (Disorder)
- What is being tested?
- Open Scarf Osteotomy and Minimally invasive scarf Osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergo hallux valgus surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Josep Torrent
Terrassa, Barcelona, 07522
josep torrent, md, +34658425678, jtorrent@mutuaterrassa.es
+34658425678, jtorrent@mutuaterrassa.es
About this study
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.
Read the 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.
- Conditions
- Hallux Valgus and Bunion (Disorder)
- Being tested
- Open Scarf Osteotomy, Minimally invasive scarf Osteotomy
- Keywords
- scarf, minimally invasive surgery, hallux valgus
- Medical subject headings
- Hallux Valgus, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Scarf OsteotomyProcedure or surgery
Open Scarf Osteotomy
Minimally invasive scarf OsteotomyProcedure or surgery
Minimally invasive scarf Osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Open Scarf Osteotomy | Active comparator | This group of patients will undergo surgery performing an open scarf osteotomy Receives: Procedure: Open Scarf Osteotomy |
| Minimally invasive scarf Osteotomy | Experimental | This group of patients will undergo surgery performing a Minimally invasive scarf osteotomy Receives: Procedure: Minimally invasive scarf Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hallux valgus angle postoperative
The angle among the first metatarsal and the first phalanx
Measured: 1 year - 2 years
Secondary outcomes (4)
Intermetatarsal 1-2 angle
The angle among the 1st and the 2nd metatarsal
Measured: 1 year - 2 years
First metatarso-phalangeal range of movement
The range of movement of the first metatarso-phalangeal joint
Measured: 1 year - 2 years
Surgery duration
The records of the surgery duration
Measured: Measurement during the surgery
Irradiation
The records of the radiation during the surgeries
Measured: Measurement during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Sep 2017
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux Valgus and Bunion (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Mutua de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, josep torrent, Hospital Mutua de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575338
- Sponsor's protocol ID
- Hospital Mútua Terrassa
- Status last verified
- Jun 2018
- First submitted
- 21 Jun 2018
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03575338
- Acronym / sponsor ID
- Hospital Mútua Terrassa
- Conditions
- Hallux Valgus and Bunion (Disorder)
- Keywords
- scarf, minimally invasive surgery, hallux valgus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Hospital Mutua de TerrassaUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Open Scarf Osteotomy | Active comparator | Procedure: Open Scarf OsteotomyThis group of patients will undergo surgery performing an open scarf osteotomy |
| Minimally invasive scarf Osteotomy | Experimental | Procedure: Minimally invasive scarf OsteotomyThis group of patients will undergo surgery performing a Minimally invasive scarf osteotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergo hallux valgus surgery
Key exclusion criteria (7 listed)
- Intermetatarsal angle >20º
- Previous hallux valgus surgery
- Metatarsalgia of the lesser rays that requires an osteotomy during the surgical procedure
- 1st cuneometatarsal instability
- Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Scarf OsteotomyOpen Scarf Osteotomy | Procedure or surgery | Open Scarf Osteotomy |
| Minimally invasive scarf OsteotomyMinimally invasive scarf Osteotomy | Procedure or surgery | Minimally invasive scarf Osteotomy |
Primary outcome
Hallux valgus angle postoperative
Time frame: 1 year - 2 years
The angle among the first metatarsal and the first phalanx
4 secondary outcomes
Intermetatarsal 1-2 angle
Time frame: 1 year - 2 years
First metatarso-phalangeal range of movement
Time frame: 1 year - 2 years
Surgery duration
Time frame: Measurement during the surgery
Irradiation
Time frame: Measurement during the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Scarf Osteotomy and Minimally invasive scarf Osteotomy in people with Hallux Valgus and Bunion (Disorder), run by Hospital Mutua de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hallux valgus angle postoperative (time frame: 1 year - 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.