MetatarsalgiaWeilvsDMMONCT02843672
Operative Treatment Of Metatarsalgia: Triple Weil Osteotomy Or Distal Metatarsal Minimal Invasive Osteotomy (DMMO)?
A study testing Triple Weil´s Osteotomy and Distal metatarsal minimally invasive osteotomy in people with Metatarsalgia, run by Manuel Cuervas-Mons at 1 site in Spain.
Trial summary
INTRODUCTION Metatarsalgia is a vague term defining a symptom instead of a specific condition. The aim of surgical treatment of metatarsalgia is to decrease the pressure under metatarsal head, shortening and / or raising the metatarsal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metatarsalgia
- What is being tested?
- Triple Weil´s Osteotomy and Distal metatarsal minimally invasive osteotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to Nov 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
- all consecutive adult patients with the diagnosis of mechanical metatarsalgia served in the Department of Orthopaedic Surgery and Traumatology of the investigative hospital, without non-operative treatment response after 6 months
Who cannot join
- traumatic metatarsalgia
- secondary metatarsalgia (diabetes, rheumatoid arthritis, or general diseases)
- equinus contracture
- active infection
- systematic disease (inflammatory, metabolic, neurologic or vascular) explaining symptoms, - metatarsophalangeal (MTPJ) dislocation higher than 5mm
- inability to complete postoperative management
- previous forefoot surgeries
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Manuel Cuervas-Mons, M.D, P.h.D, 915868426, manuel.cuervasmons@gmail.com
About this study
Official title: Open Randomized Controlled Clinical Trial To Assess Functional Outcomes Between Two Therapeutic Options In The Surgical Treatment Of Metatarsalgia: Triple Weil Osteotomy (Two) And Distal Metatarsal Osteotomy Minimally Invasive (DMMO)
INTRODUCTION
Metatarsalgia is a vague term defining a symptom instead of a specific condition. The aim of surgical treatment of metatarsalgia is to decrease the pressure under metatarsal head, shortening and / or raising the metatarsal. It has been somewhat controversial, with more than 25 different lesser metatarsal osteotomies described to date.
Read more
The Triple´s Weil osteotomy described by Maceira is the most widely used surgical treatment in open distal metatarsal surgery but nowadays, percutaneous osteotomy has proven to be a valid technique that yields results similar to open osteotomy for the treatment of metatarsalgia and other forefoot problems. It has been somewhat controversial the choice between the different operative treatments, being nowadays the triple´s Weil osteotomy (TWO) and the distal minimally invasive osteotomy (DMMO) the most popular, gaining both defenders and retractors surgeons in open and percutaneous surgery.
The purpose of this study is to compare the clinical results between two different surgical treatments: triple´s Weil osteotomy (TWO) and distal minimal invasive osteotomy (DMMO).
MATERIAL AND METHODS
The investigators design an open randomized controlled clinical trial with patients operated in the same centre.
The patients are randomized to TWO and DMMO groups. Number of osteotomies is based on the criteria of Leventen formula. In all patients the metatarsal osteotomy can be combined with different surgical procedures in presence of associated deformities: (i) SCARF osteotomy for hallux valgus (HV) deformity, (ii) flexor and extensor tenotomies with distal phalangeal percutaneous osteotomy for lesser toes deformities.
Read the detailed description
INTRODUCTION
Metatarsalgia is a vague term defining a symptom instead of a specific condition. The aim of surgical treatment of metatarsalgia is to decrease the pressure under metatarsal head, shortening and / or raising the metatarsal, thus removing the overload and preserving the joint integrity. It has been somewhat controversial, with more than 25 different lesser metatarsal osteotomies described to date. The Weil osteotomy is the most widely used surgical treatment in open distal metatarsal surgery, a popularity based upon the simple technique, stable fixation, excellent union rates and predictable results.
According to the principles of traditional surgery, surgical manoeuvres requiring large incisions and aggressive techniques should be needed to effectively resolve the different pathological elements producing the deformity in order to eliminate this serious injury. These principles concerns surgeons like White, who described a modification of the distal metaphyseal osteotomy through a percutaneous approach without visualization and without internal fixation to obtain a metatarsal in optimal weight-bearing position. Percutaneous surgery of the foot, also known as minimal invasive surgery (MIS), allows interventions to be carried out through extremely small incisions without direct exposure of the surgical field under radiologic monitoring, thus causing minimal injury to adjacent tissues, and reducing the surgical trauma. Over the last few years, Foot Surgery has come to be recognised as a major Orthopaedic subspecialty, where the percutaneous surgery plays an important role. The Triple´s Weil osteotomy described by Maceira is the most widely used surgical treatment in open distal metatarsal surgery but nowadays, percutaneous osteotomy has proven to be a valid technique that yields results similar to open osteotomy for the treatment of metatarsalgia and other forefoot problems. It has been somewhat controversial the choice between the different operative treatments, being nowadays the triple´s Weil osteotomy (TWO) and the distal minimally invasive osteotomy (DMMO) the most popular, gaining both defenders and retractors surgeons in open and percutaneous surgery.
The purpose of this study is to compare the clinical results between two different surgical treatments: triple´s Weil osteotomy (TWO) and distal minimal invasive osteotomy (DMMO).
MATERIAL AND METHODS
The investigators design an open randomized controlled clinical trial with patients operated in the same centre.
The patients are randomized to TWO and DMMO groups. Number of osteotomies is based on the criteria of Leventen formula. In all patients the metatarsal osteotomy can be combined with different surgical procedures in presence of associated deformities: (i) SCARF osteotomy for hallux valgus (HV) deformity, (ii) flexor and extensor tenotomies with distal phalangeal percutaneous osteotomy for lesser toes deformities.
- Conditions
- Metatarsalgia
- Being tested
- Triple Weil´s Osteotomy, Distal metatarsal minimally invasive osteotomy
- Keywords
- metatarsalgia, surgery, weil, MIS, percutaneous, DMMO
- Medical subject headings
- Metatarsalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple Weil´s OsteotomyProcedure or surgery
Also called TWO
A 10mm longitudinal incision is made with a No.15 blade in the second intermetatarsal space immediately behind the dorsal interdigital fold, parallel to the extensor tendon. An intra-articular osteotomy in the metatarsal head is performed angled 45º relative to the long axis of the metatarsal and in a dorsal-distal to proximal-plantar direction. A second osteotomy is performed perpendicular to the metatarsal shaft,.The osteotomy is fastened with a 2.0mm snap-off screw.
Once all the osteotomies are completed, the incisions are closed with a 2/0 monofilament suture.
Distal metatarsal minimally invasive osteotomyProcedure or surgery
Also called DMMO
A 5mm longitudinal incision is made with a MIS blade No.64 in the intermetatarsal space immediately behind the dorsal interdigital fold, parallel to the extensor tendon. Under fluoroscopy vision, an extra-articular osteotomy in the metatarsal neck is performed angled 45º relative to the long axis of the metatarsal and in a dorsal-distal to proximal-plantar direction. The osteotomies scheduled preoperatively are performed, repeating the same procedure for each ray needing an osteotomy. Once all are completed, the incisions are closed with a 4/0 monofilament suture.
| Study group | Role | What they receive |
|---|---|---|
| TWO | Active comparator | Patients with metatarsalgia and without response to non-operative treatment after six months, needing surgical treatment for relief of their symptoms.
Triple´s Weil osteotomy is performed. Receives: Procedure: Triple Weil´s Osteotomy |
| DMMO | Active comparator | Patients with metatarsalgia and without response to non-operative treatment after six months, needing surgical treatment for relief of their symptoms.
Distal metatarsal minimally invasive osteotomy is performed. Receives: Procedure: Distal metatarsal minimally invasive osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline American Orthopaedic Foot and Ankle Society score (AOFAS) at 3 and 12 months
Score for pain, function and alignment
Measured: Preoperative, 3 months follow-up and 12 months follow-up
Change from Baseline Short form Health survey 36 (SF-36) at 3 and 12 months
Score for quality of life
Measured: Preoperative, 3 months follow-up and 12 months follow-up
Change from Baseline Visual Analog Score (VAS) at 3 and 12 months
Score for pain
Measured: Preoperative, 3 months follow-up and 12 months follow-up
Benton-Weil´s questionnaire
The questionnaire incorporate actual VAS and clinical results subjectively evaluated with three questions:
(i) Does the surgery meet your expectations? (ii) Would you recommend the procedure to a friend in similar conditions? (iii) Would you have undergone the procedure, knowing now your outcome?
Measured: 12 months follow-up
Secondary outcomes (2)
Change from 3 months MTPJ joint mobility at 12 months
Metatarso-phalangeal joint (MTPJ) mobility described as the range of motion (ROM) of the joint, measured by a goniometer MTPJ range of motion is measured in a open chain patient who is lying down with the knee extended and the foot at rest in spontaneous plantar flexion.
Full ROM of plantar flexion combined with dorsiflexion was classified in: normal ROM ≥70º, moderately stiff ROM 30º to 70º, and severely stiff ROM < 30º..
Measured: 3 months follow-up and 12 months follow-up
Change from Baseline Metatarsal formula at 12 months
Changes in the radiological metatarsal formula are measured with the average recoil of the metatarsal heads between the preoperative and the 12 months follow up measurement.
Measured: Preoperative and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetatarsalgiaStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manuel Cuervas-Mons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manuel Cuervas-Mons, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843672
- Sponsor's protocol ID
- CUERVASMONS
- Acronym
- WeilvsDMMO
- Status last verified
- Mar 2018
- First submitted
- 5 Jul 2016
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Randomized Controlled Clinical Trial To Assess Functional Outcomes Between Two Therapeutic Options In The Surgical Treatment Of Metatarsalgia: Triple Weil Osteotomy (Two) And Distal Metatarsal Osteotomy Minimally Invasive (DMMO)
- ClinicalTrials.gov ID
- NCT02843672
- Acronym / sponsor ID
- WeilvsDMMO / CUERVASMONS
- Conditions
- Metatarsalgia
- Keywords
- metatarsalgia, surgery, weil, MIS, percutaneous, DMMO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Manuel Cuervas-MonsUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 26 Jul 2016 (estimated)
- 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.
INTRODUCTION
Metatarsalgia is a vague term defining a symptom instead of a specific condition. The aim of surgical treatment of metatarsalgia is to decrease the pressure under metatarsal head, shortening and / or raising the metatarsal. It has been somewhat controversial, with more than 25 different lesser metatarsal osteotomies described to date.
The Triple´s Weil osteotomy described by Maceira is the most widely used surgical treatment in open distal metatarsal surgery but nowadays, percutaneous osteotomy has proven to be a valid technique that yields results similar to open osteotomy for the treatment of metatarsalgia and other forefoot problems. It has been somewhat controversial the choice between the different operative treatments, being nowadays the triple´s Weil osteotomy (TWO) and the distal minimally invasive osteotomy (DMMO) the most popular, gaining both defenders and retractors surgeons in open and percutaneous surgery.
The purpose of this study is to compare the clinical results between two different surgical treatments: triple´s Weil osteotomy (TWO) and distal minimal invasive osteotomy (DMMO).
MATERIAL AND METHODS
The investigators design an open randomized controlled clinical trial with patients operated in the same centre.
The patients are randomized to TWO and DMMO groups. Number of osteotomies is based on the criteria of Leventen formula. In all patients the metatarsal osteotomy can be combined with different surgical procedures in presence of associated deformities: (i) SCARF osteotomy for hallux valgus (HV) deformity, (ii) flexor and extensor tenotomies with distal phalangeal percutaneous osteotomy for lesser toes deformities.
Detailed description
INTRODUCTION
Metatarsalgia is a vague term defining a symptom instead of a specific condition. The aim of surgical treatment of metatarsalgia is to decrease the pressure under metatarsal head, shortening and / or raising the metatarsal, thus removing the overload and preserving the joint integrity. It has been somewhat controversial, with more than 25 different lesser metatarsal osteotomies described to date. The Weil osteotomy is the most widely used surgical treatment in open distal metatarsal surgery, a popularity based upon the simple technique, stable fixation, excellent union rates and predictable results.
According to the principles of traditional surgery, surgical manoeuvres requiring large incisions and aggressive techniques should be needed to effectively resolve the different pathological elements producing the deformity in order to eliminate this serious injury. These principles concerns surgeons like White, who described a modification of the distal metaphyseal osteotomy through a percutaneous approach without visualization and without internal fixation to obtain a metatarsal in optimal weight-bearing position. Percutaneous surgery of the foot, also known as minimal invasive surgery (MIS), allows interventions to be carried out through extremely small incisions without direct exposure of the surgical field under radiologic monitoring, thus causing minimal injury to adjacent tissues, and reducing the surgical trauma. Over the last few years, Foot Surgery has come to be recognised as a major Orthopaedic subspecialty, where the percutaneous surgery plays an important role. The Triple´s Weil osteotomy described by Maceira is the most widely used surgical treatment in open distal metatarsal surgery but nowadays, percutaneous osteotomy has proven to be a valid technique that yields results similar to open osteotomy for the treatment of metatarsalgia and other forefoot problems. It has been somewhat controversial the choice between the different operative treatments, being nowadays the triple´s Weil osteotomy (TWO) and the distal minimally invasive osteotomy (DMMO) the most popular, gaining both defenders and retractors surgeons in open and percutaneous surgery.
The purpose of this study is to compare the clinical results between two different surgical treatments: triple´s Weil osteotomy (TWO) and distal minimal invasive osteotomy (DMMO).
MATERIAL AND METHODS
The investigators design an open randomized controlled clinical trial with patients operated in the same centre.
The patients are randomized to TWO and DMMO groups. Number of osteotomies is based on the criteria of Leventen formula. In all patients the metatarsal osteotomy can be combined with different surgical procedures in presence of associated deformities: (i) SCARF osteotomy for hallux valgus (HV) deformity, (ii) flexor and extensor tenotomies with distal phalangeal percutaneous osteotomy for lesser toes deformities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TWO | Active comparator | Procedure: Triple Weil´s OsteotomyPatients with metatarsalgia and without response to non-operative treatment after six months, needing surgical treatment for relief of their symptoms. Triple´s Weil osteotomy is performed. |
| DMMO | Active comparator | Procedure: Distal metatarsal minimally invasive osteotomyPatients with metatarsalgia and without response to non-operative treatment after six months, needing surgical treatment for relief of their symptoms. Distal metatarsal minimally invasive osteotomy is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive adult patients with the diagnosis of mechanical metatarsalgia served in the Department of Orthopaedic Surgery and Traumatology of the investigative hospital, without non-operative treatment response after 6 months
Key exclusion criteria (7 listed)
- traumatic metatarsalgia
- secondary metatarsalgia (diabetes, rheumatoid arthritis, or general diseases)
- equinus contracture
- active infection
- systematic disease (inflammatory, metabolic, neurologic or vascular) explaining symptoms, - metatarsophalangeal (MTPJ) dislocation higher than 5mm
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 |
|---|---|---|
| Triple Weil´s OsteotomyAlso: TWOA 10mm longitudinal incision is made with a No.15 blade in the second intermetatarsal space immediately behind the dorsal interdigital fold, parallel to the extensor tendon. An intra-articular osteotomy in the metatarsal head is performed angled 45º relative to the long axis of the metatarsal and in a dorsal-distal to proximal-plantar direction. A second osteotomy is performed perpendicular to the metatarsal shaft,.The osteotomy is fastened with a 2.0mm snap-off screw. Once all the osteotomies are completed, the incisions are closed with a 2/0 monofilament suture. | Procedure or surgery | TWO |
| Distal metatarsal minimally invasive osteotomyAlso: DMMOA 5mm longitudinal incision is made with a MIS blade No.64 in the intermetatarsal space immediately behind the dorsal interdigital fold, parallel to the extensor tendon. Under fluoroscopy vision, an extra-articular osteotomy in the metatarsal neck is performed angled 45º relative to the long axis of the metatarsal and in a dorsal-distal to proximal-plantar direction. The osteotomies scheduled preoperatively are performed, repeating the same procedure for each ray needing an osteotomy. Once all are completed, the incisions are closed with a 4/0 monofilament suture. | Procedure or surgery | DMMO |
Primary outcome
Change from Baseline American Orthopaedic Foot and Ankle Society score (AOFAS) at 3 and 12 months
Time frame: Preoperative, 3 months follow-up and 12 months follow-up
Score for pain, function and alignment
Change from Baseline Short form Health survey 36 (SF-36) at 3 and 12 months
Time frame: Preoperative, 3 months follow-up and 12 months follow-up
Score for quality of life
Change from Baseline Visual Analog Score (VAS) at 3 and 12 months
Time frame: Preoperative, 3 months follow-up and 12 months follow-up
Score for pain
Benton-Weil´s questionnaire
Time frame: 12 months follow-up
The questionnaire incorporate actual VAS and clinical results subjectively evaluated with three questions: (i) Does the surgery meet your expectations? (ii) Would you recommend the procedure to a friend in similar conditions? (iii) Would you have undergone the procedure, knowing now your outcome?
2 secondary outcomes
Change from 3 months MTPJ joint mobility at 12 months
Time frame: 3 months follow-up and 12 months follow-up
Change from Baseline Metatarsal formula at 12 months
Time frame: Preoperative and 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Individual participant dataSharing planned: No
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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 Triple Weil´s Osteotomy and Distal metatarsal minimally invasive osteotomy in people with Metatarsalgia, run by Manuel Cuervas-Mons 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 20 Mar 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?
Contact Manuel Cuervas-Mons, Investigator (+34649818463, manuel.cuervasmons@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline American Orthopaedic Foot and Ankle Society score (AOFAS) at 3 and 12 months (time frame: Preoperative, 3 months follow-up and 12 months follow-up). The study lists 4 primary outcomes in all. 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 20 Mar 2018.