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

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Hammer Toe; Deformity of Toe; Phalanx; Dislocation Toe(S)
• Intervention / Treatment: Procedure: Arthrodesis interphalangeal with intramedullary resorbable fixation system

Detailed Description

A comparative, prospective, randomised study.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41009
    • Manuel Coheña Jiménez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: intramedullary reabsorbable fixation system PLLA.; Arthrodesis interphalangeal with intramedullary reabsorbable fixation system PLLA.	Procedure: Arthrodesis interphalangeal with intramedullary resorbable fixation system; Interphalangeal arthrodesis of lesser toes with two different fixation systems.; Other Names: Arthrodesis interphalangeal with kirschner wire fixation system
PLACEBO_COMPARATOR: K-wire; Arthrodesis interphalangeal with kirschner wire	Procedure: Arthrodesis interphalangeal with intramedullary resorbable fixation system; Interphalangeal arthrodesis of lesser toes with two different fixation systems.; Other Names: Arthrodesis interphalangeal with kirschner wire fixation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Study Director: Pedro Montaño Jiménez, PhD, University of Seville; Study Director: Luis María Gordillo Fernández, PhD, University of Seville; Principal Investigator: Juan Manuel Muriel Sánchez, University of Seville; Study Director: Manuel Coheña Jiménez, PhD, University of Seville

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): May 23, 2019
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (ACTUAL): October 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: PLLA; arthodesis; kirschner wire
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Congenital Abnormalities; Hammer Toe Syndrome
• Other Study ID Numbers: University of Seville-USeville

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No