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

University of Seville

Status

Completed

Conditions

Phalanx; Dislocation Toe(S)

Surgery

Deformity of Toe

Hammer Toe

Treatments

Procedure: Arthrodesis interphalangeal with intramedullary resorbable fixation system

Study type

Interventional

Funder types

Other

Identifiers

NCT04610437

University of Seville-USeville

Details and patient eligibility

About

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.

Full description

A comparative, prospective, randomised study.

Enrollment

30 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical and radiological evidence of rigid hammer toe.
Non-smoking patient.
Have no previous surgical episode or known trauma to the foot or ankle of the same limb.
Not have any significant medical comorbidity:
Uncontrolled hypertension.
Previous myocardial infarction.
Neoplasms.
Chronic obstructive pulmonary disease.
Arrhythmias.
Morbid obesity.
Uncontrolled diabetes mellitus.
Peripheral vascular disease.
Peripheral neuropathy.
Lumbar disc herniation.
Any neuro-muscular alteration.
That the patient present:
Palpable peripheral pulses through the posterior tibial artery and pedia.
Ankle-brachial index or YAO between 1-1.2.
Partial oxygen saturation> or = 95%.

Exclusion criteria

That the patient has undergone another previous surgical procedure on the same foot.
Known trauma to the foot to be intervened.
History of sensitivity to local anesthetics.
Pregnant or lactating women.
Follow-up time less than 90 days.
Patients with any systemic pathology or in chronic treatment that could interfere with the favorable evolution of the process.