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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04610437
• Other study ID #: University of Seville-USeville
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2020
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A comparative, prospective, randomised study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 30, 2020
• Est. primary completion date: May 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Arthrodesis interphalangeal with intramedullary resorbable fixation system
Interphalangeal arthrodesis of lesser toes with two different fixation systems.

Locations

Country	Name	City	State
Spain	Manuel Coheña Jiménez	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of AOFAS MTP-IP for the lesser toes	Each measure is comprised of nine questions and cover three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points.	baseline, 6 weeks, 6 months
Secondary	Change of Finger alignment.	X-ray in dorsal-plantar projection in load to measure the angle formed between the longitudinal axes of the proximal and middle phalanges. Good: 0-10º. (tb smartoe vs kw buried and the other from smartoe); Enough: 11-20º; or Bad:> 20º.	Baseline, 6 weeks, 6 months
Secondary	Change of visual analog scale	Heel pain intensity was referred to as 0-10, in which 0= no pain at all and 10= the worst pain possible	Baseline, 6 weeks, 6 months
Secondary	Level of Satisfaction	Satisfaction assessed by the scale.This is a self-administered scale of satisfaction with the procedure with 4 categories. The response categories consisting of very satisfied (4 points), somewhat satisfied (3 points), somewhat dissatisfied ( 2 points), and very dissatisfied (1 points).	Baseline, 6 weeks, 6 months
Secondary	Change of Foot health status questionnaire	Foot Health Status Questionnaire: The questionnaire to measure foot health related quality of life. The Foot Health Status Questionnaire Data Analysis Software obtain the scale scores for the domains of; Foot Pain, Foot Function, Footwear, General Foot Health Perceptions from respondent's answers on the questionnaire.The questionnaire does not providean overall score. To obtain these indexes, the responsesare analysed through computer software (FHSQ, version1.03). After processing the data, the software produces ascore ranging from 0 to 100. The maximum score is in-dicative of a person with excellent foot health, no painor discomfort and no difficulty or limitations in puttingon shoes, performing activities of daily life or work, with adequate functional capacity; a score of zero representsthe worst state of health for the foot.	Baseline, 6 weeks, 6 months