Operative Treatment Of Metatarsalgia: Triple Weil Osteotomy Or Distal Metatarsal Minimal Invasive Osteotomy (DMMO)?
NCT02843672 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2018-03-20
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
Interventions
- PROCEDURE
-
Triple Weil´s Osteotomy
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.
- PROCEDURE
-
Distal metatarsal minimally invasive osteotomy
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.
Sponsors & Collaborators
-
Manuel Cuervas-Mons
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-31
- Primary Completion
- 2018-11-30
- Completion
- 2019-11-30
Countries
- Spain
Study Locations
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