Intramedullary Resorbable Fixation System Versus K-wire for the Treatment of Lesser Toe Deformities
NCT ID: NCT04610437
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-05-01
2020-09-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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intramedullary reabsorbable fixation system PLLA.
Arthrodesis interphalangeal with intramedullary reabsorbable fixation system PLLA.
Arthrodesis interphalangeal with intramedullary resorbable fixation system
Interphalangeal arthrodesis of lesser toes with two different fixation systems.
K-wire
Arthrodesis interphalangeal with kirschner wire
Arthrodesis interphalangeal with intramedullary resorbable fixation system
Interphalangeal arthrodesis of lesser toes with two different fixation systems.
Interventions
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Arthrodesis interphalangeal with intramedullary resorbable fixation system
Interphalangeal arthrodesis of lesser toes with two different fixation systems.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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University of Seville
OTHER
Responsible Party
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Manuel Coheña-Jiménez
PhD- principal investigator and clinical professor
Principal Investigators
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Pedro Montaño Jiménez, PhD
Role: STUDY_DIRECTOR
University of Seville
Luis María Gordillo Fernández, PhD
Role: STUDY_DIRECTOR
University of Seville
Juan Manuel Muriel Sánchez
Role: PRINCIPAL_INVESTIGATOR
University of Seville
Manuel Coheña Jiménez, PhD
Role: STUDY_DIRECTOR
University of Seville
Locations
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Manuel Coheña Jiménez
Seville, , Spain
Countries
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Other Identifiers
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University of Seville-USeville
Identifier Type: -
Identifier Source: org_study_id