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

Primary Purpose

Hammer Toe, Surgery, Deformity of Toe

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Arthrodesis interphalangeal with intramedullary resorbable fixation system
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hammer Toe focused on measuring arthodesis, kirschner wire, PLLA

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Manuel Coheña Jiménez

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intramedullary reabsorbable fixation system PLLA.

K-wire

Arm Description

Arthrodesis interphalangeal with intramedullary reabsorbable fixation system PLLA.

Arthrodesis interphalangeal with kirschner wire

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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).
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.

Full Information

First Posted
October 22, 2020
Last Updated
November 12, 2020
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT04610437
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 23, 2019 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hammer Toe, Surgery, Deformity of Toe, Phalanx; Dislocation Toe(S)
Keywords
arthodesis, kirschner wire, PLLA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intramedullary reabsorbable fixation system PLLA.
Arm Type
Active Comparator
Arm Description
Arthrodesis interphalangeal with intramedullary reabsorbable fixation system PLLA.
Arm Title
K-wire
Arm Type
Placebo Comparator
Arm Description
Arthrodesis interphalangeal with kirschner wire
Intervention Type
Procedure
Intervention Name(s)
Arthrodesis interphalangeal with intramedullary resorbable fixation system
Other Intervention Name(s)
Arthrodesis interphalangeal with kirschner wire fixation system
Intervention Description
Interphalangeal arthrodesis of lesser toes with two different fixation systems.
Primary Outcome Measure Information:
Title
Change of AOFAS MTP-IP for the lesser toes
Description
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.
Time Frame
baseline, 6 weeks, 6 months
Secondary Outcome Measure Information:
Title
Change of Finger alignment.
Description
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.
Time Frame
Baseline, 6 weeks, 6 months
Title
Change of visual analog scale
Description
Heel pain intensity was referred to as 0-10, in which 0= no pain at all and 10= the worst pain possible
Time Frame
Baseline, 6 weeks, 6 months
Title
Level of Satisfaction
Description
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).
Time Frame
Baseline, 6 weeks, 6 months
Title
Change of Foot health status questionnaire
Description
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.
Time Frame
Baseline, 6 weeks, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Montaño Jiménez, PhD
Organizational Affiliation
University of Seville
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Luis María Gordillo Fernández, PhD
Organizational Affiliation
University of Seville
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Juan Manuel Muriel Sánchez
Organizational Affiliation
University of Seville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuel Coheña Jiménez, PhD
Organizational Affiliation
University of Seville
Official's Role
Study Director
Facility Information:
Facility Name
Manuel Coheña Jiménez
City
Seville
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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