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

NCT02843672 | Unknown DMC

• 1 other identifier: CUERVASMONS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Metatarsalgia

Keywords

metatarsalgia; surgery; weil; MIS; percutaneous; DMMO

Outcome Measures

Primary Outcomes (4)

• Change from Baseline American Orthopaedic Foot and Ankle Society score (AOFAS) at 3 and 12 months

  Score for pain, function and alignment

  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

  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

  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?

  12 months follow-up

Secondary Outcomes (2)

• Change from 3 months MTPJ joint mobility at 12 months

  3 months follow-up and 12 months follow-up

• Change from Baseline Metatarsal formula at 12 months

  Preoperative and 12 months follow-up

Study Arms (2)

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.

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.

Procedure: Distal metatarsal minimally invasive osteotomy

Interventions

Triple Weil´s Osteotomy PROCEDURE

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.

Also known as: TWO

TWO

Distal metatarsal minimally invasive osteotomy PROCEDURE

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.

Also known as: DMMO

DMMO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manuel Cuervas-Mons: lead

Study Sites (1)

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

MeSH Terms

Conditions

Metatarsalgia

Condition Hierarchy (Ancestors)

Foot Diseases; Musculoskeletal Diseases; Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Manuel Cuervas-Mons, Investigator

CONTACT

+34649818463; manuel.cuervasmons@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 26, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: March 20, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)