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

NCT04610437 | Completed DMC

• 1 other identifier: University of Seville-USeville
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

arthodesis; kirschner wire; PLLA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of Finger alignment.

  Baseline, 6 weeks, 6 months

• Change of visual analog scale

  Baseline, 6 weeks, 6 months

• Level of Satisfaction

  Baseline, 6 weeks, 6 months

• Change of Foot health status questionnaire

  Baseline, 6 weeks, 6 months

Study Arms (2)

intramedullary reabsorbable fixation system PLLA.

ACTIVE COMPARATOR

Arthrodesis interphalangeal with intramedullary reabsorbable fixation system PLLA.

Procedure: Arthrodesis interphalangeal with intramedullary resorbable fixation system

K-wire

PLACEBO COMPARATOR

Arthrodesis interphalangeal with kirschner wire

Procedure: Arthrodesis interphalangeal with intramedullary resorbable fixation system

Interventions

Arthrodesis interphalangeal with intramedullary resorbable fixation system PROCEDURE

Interphalangeal arthrodesis of lesser toes with two different fixation systems.

Also known as: Arthrodesis interphalangeal with kirschner wire fixation system

K-wire; intramedullary reabsorbable fixation system PLLA.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Manuel Coheña Jiménez

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Hammer Toe Syndrome

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• Pedro Montaño Jiménez, PhD

  University of Seville

  STUDY DIRECTOR

• Luis María Gordillo Fernández, PhD

  University of Seville

  STUDY DIRECTOR

• Juan Manuel Muriel Sánchez

  University of Seville

  PRINCIPAL INVESTIGATOR

• Manuel Coheña Jiménez, PhD

  University of Seville

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD- principal investigator and clinical professor

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 30, 2020
• Study Start: May 1, 2019
• Primary Completion: May 23, 2019
• Study Completion: September 30, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)