NCT04610437

Intramedullary Resorbable Fixation System Versus K-wire for the Treatment of Lesser Toe Deformities

Fixation of Digital Arthrodesis With Percutaneous Kirschner Wire Versus Intramedullary Fixation With Resorbable Polylactic Acid Needle: A Comparative Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Seville · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Hammertoe deformity is one of the most common deformities in the foot and is characterized by dorsiflexion of the proximal phalanx at the metatarsal-phalangeal joint and a plantarflexion of the middle phalanx at the proximal interphalangeal joint. Surgical intervention for this type of deformity is indicated when the symptoms progress and conservative treatments are not enough, that is, when we are faced with a rigid painful deformity.Arthrodesis of the proximal interphalangeal joint temporarily fixed with a Kirschner wire is the most commonly used techniques. Therefore, intramedullary fixation with a PLLA needle may be a good alternative. The use of biomaterial is gaining relevance in foot surgery, with polylactic acid being the most widely used due to its strength. Its total biodegradation requires a time of 16-24 months. No cases of foreign body reaction have been described with this type of osteosynthesis material, due to its characteristics similar to those of bone. Its only drawbacks are that it increases the complexity of the technique and that it increases the cost of the procedure. Being a flexible needle, it allows to leave a functional intraoperative claw. It maintains the functionality of the distal interphalangeal joint and carries a lower risk of infection by carrying osteosynthesis material on the outside. The purpose of the present study is to prospectively collect clinical and radiographic outcomes of operative correction of hammertoe deformity using a fixation system of intramedullary device of polylactic acid versus a kirschner wire.

Detailed description

A comparative, prospective, randomised study.

Conditions

• Hammer Toe
• Surgery
• Deformity of Toe
• Phalanx; Dislocation Toe(S)

Interventions

Type	Name	Description
PROCEDURE	Arthrodesis interphalangeal with intramedullary resorbable fixation system	Interphalangeal arthrodesis of lesser toes with two different fixation systems.

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-05-23
• Completion: 2020-09-30
• First posted: 2020-10-30
• Last updated: 2020-11-17

Locations

1 site across 1 country: Spain