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

M

Manuel Cuervas-Mons

Status

Unknown

Conditions

Metatarsalgia

Treatments

Procedure: Distal metatarsal minimally invasive osteotomy
Procedure: Triple Weil´s Osteotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02843672
CUERVASMONS

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

TWO
Active Comparator group
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.
Treatment:
Procedure: Triple Weil´s Osteotomy
DMMO
Active Comparator group
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.
Treatment:
Procedure: Distal metatarsal minimally invasive osteotomy

Trial contacts and locations

1

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Central trial contact

Manuel Cuervas-Mons, Investigator

Data sourced from clinicaltrials.gov

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