Fixation of Digital Arthrodesis With Percutaneous Kirschner Wire Versus Intramedullary Fixation With Resorbable Polylactic Acid Needle: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of AOFAS MTP-IP for the lesser toes
研究概览
简要总结
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.
详细描述
A comparative, prospective, randomised study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Partial oxygen saturation> or = 95%.
排除标准
- •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.
结局指标
主要结局
Change of AOFAS MTP-IP for the lesser toes
时间窗: baseline, 6 weeks, 6 months
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.
次要结局
- Level of Satisfaction(Baseline, 6 weeks, 6 months)
- Change of Foot health status questionnaire(Baseline, 6 weeks, 6 months)
- Change of Finger alignment.(Baseline, 6 weeks, 6 months)
- Change of visual analog scale(Baseline, 6 weeks, 6 months)
研究者
Manuel Coheña-Jiménez
PhD- principal investigator and clinical professor
University of Seville