Clinical trial NCT04610437: Intramedullary Resorbable Fixation System Versus K-wire for the Treatment of Lesser Toe Deformities
Official title: Fixation of Digital Arthrodesis With Percutaneous Kirschner Wire Versus Intramedullary Fixation With Resorbable Polylactic Acid Needle: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hammer Toe
Surgery
Deformity of Toe
Phalanx; Dislocation Toe(S)
Keywords: arthodesis
kirschner wire
PLLA
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of AOFAS MTP-IP for the lesser toes
timeFrame: baseline, 6 weeks, 6 months
Secondary outcomes:
measure: Change of Finger alignment.
timeFrame: Baseline, 6 weeks, 6 months
measure: Change of visual analog scale
timeFrame: Baseline, 6 weeks, 6 months
measure: Level of Satisfaction
timeFrame: Baseline, 6 weeks, 6 months
measure: Change of Foot health status questionnaire
timeFrame: Baseline, 6 weeks, 6 months
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Manuel Coheña Jiménez
Study officials:
affiliation: University of Seville
name: Pedro Montaño Jiménez, PhD
role: STUDY_DIRECTOR
affiliation: University of Seville
name: Luis María Gordillo Fernández, PhD
role: STUDY_DIRECTOR
affiliation: University of Seville
name: Juan Manuel Muriel Sánchez
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Seville
name: Manuel Coheña Jiménez, PhD
role: STUDY_DIRECTOR
References: