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Operative Treatment Of Metatarsalgia: Triple Weil Osteotomy Or Distal Metatarsal Minimal Invasive Osteotomy (DMMO)? (WeilvsDMMO)

Primary Purpose

Metatarsalgia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Triple Weil´s Osteotomy
Distal metatarsal minimally invasive osteotomy
Sponsored by
Manuel Cuervas-Mons
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metatarsalgia focused on measuring metatarsalgia, surgery, weil, MIS, percutaneous, DMMO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hospital General Universitario Gregorio MarañonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TWO

DMMO

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline American Orthopaedic Foot and Ankle Society score (AOFAS) at 3 and 12 months
Score for pain, function and alignment
Change from Baseline Short form Health survey 36 (SF-36) at 3 and 12 months
Score for quality of life
Change from Baseline Visual Analog Score (VAS) at 3 and 12 months
Score for pain
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?

Secondary Outcome Measures

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..
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.

Full Information

First Posted
July 5, 2016
Last Updated
March 18, 2018
Sponsor
Manuel Cuervas-Mons
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1. Study Identification

Unique Protocol Identification Number
NCT02843672
Brief Title
Operative Treatment Of Metatarsalgia: Triple Weil Osteotomy Or Distal Metatarsal Minimal Invasive Osteotomy (DMMO)?
Acronym
WeilvsDMMO
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Manuel Cuervas-Mons

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metatarsalgia
Keywords
metatarsalgia, surgery, weil, MIS, percutaneous, DMMO

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TWO
Arm Type
Active Comparator
Arm Description
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.
Arm Title
DMMO
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Triple Weil´s Osteotomy
Other Intervention Name(s)
TWO
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Distal metatarsal minimally invasive osteotomy
Other Intervention Name(s)
DMMO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline American Orthopaedic Foot and Ankle Society score (AOFAS) at 3 and 12 months
Description
Score for pain, function and alignment
Time Frame
Preoperative, 3 months follow-up and 12 months follow-up
Title
Change from Baseline Short form Health survey 36 (SF-36) at 3 and 12 months
Description
Score for quality of life
Time Frame
Preoperative, 3 months follow-up and 12 months follow-up
Title
Change from Baseline Visual Analog Score (VAS) at 3 and 12 months
Description
Score for pain
Time Frame
Preoperative, 3 months follow-up and 12 months follow-up
Title
Benton-Weil´s questionnaire
Description
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?
Time Frame
12 months follow-up
Secondary Outcome Measure Information:
Title
Change from 3 months MTPJ joint mobility at 12 months
Description
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..
Time Frame
3 months follow-up and 12 months follow-up
Title
Change from Baseline Metatarsal formula at 12 months
Description
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.
Time Frame
Preoperative and 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Cuervas-Mons, Investigator
Phone
+34649818463
Email
manuel.cuervasmons@gmail.com
Facility Information:
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Cuervas-Mons, M.D, P.h.D
Phone
915868426
Email
manuel.cuervasmons@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Operative Treatment Of Metatarsalgia: Triple Weil Osteotomy Or Distal Metatarsal Minimal Invasive Osteotomy (DMMO)?

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