Clinical trial NCT02843672: Operative Treatment Of Metatarsalgia: Triple Weil Osteotomy Or Distal Metatarsal Minimal Invasive Osteotomy (DMMO)?
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
Overall status: UNKNOWN
Phase: NA
Conditions: Metatarsalgia
Keywords: metatarsalgia
surgery
weil
MIS
percutaneous
DMMO
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline American Orthopaedic Foot and Ankle Society score (AOFAS) at 3 and 12 months
timeFrame: Preoperative, 3 months follow-up and 12 months follow-up
measure: Change from Baseline Short form Health survey 36 (SF-36) at 3 and 12 months
timeFrame: Preoperative, 3 months follow-up and 12 months follow-up
measure: Change from Baseline Visual Analog Score (VAS) at 3 and 12 months
timeFrame: Preoperative, 3 months follow-up and 12 months follow-up
measure: Benton-Weil´s questionnaire
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Change from 3 months MTPJ joint mobility at 12 months
timeFrame: 3 months follow-up and 12 months follow-up
measure: Change from Baseline Metatarsal formula at 12 months
timeFrame: Preoperative and 12 months follow-up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
Study officials:
References: