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临床试验/NCT05717413
NCT05717413招募中不适用

New Method of Surgical Treatment of Patients With Osteoarthritis of the 1st Metatarsophalangeal Joint

Samara State Medical University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
46
试验地点
1
主要终点
Dynamics of quality of life indicators using questionnaires

研究概览

简要总结

Relevance The first metatarsophalangeal joint (MPJ) has an important function in the biomechanics of human gait, especially in the toe and thrust phases, as the full range of motion at this joint provides the body with smooth horizontal acceleration. The flattening of the arches of the foot and, as a result, the overload of its anterior section occupy a leading place in the etiology of deforming osteoarthritis (Hallux rigidus). Hallux rigidus is a disease associated with degenerative changes in the articular cartilage of the first metatarsophalangeal joint. The relevance of the treatment of arthrosis of the first metatarsophalangeal joint is determined by the high incidence and functional significance of the joint.

At the 3rd and 4th degrees of arthrosis, arthrodesis, resection arthroplasty and arthroplasty of the first metatarsophalangeal joint are used.

To date, the most optimal methods of surgical treatment of severe arthrosis of the first metatarsophalangeal joint are arthroplasty and arthrodesis of the joint. These operations are preferred because they achieve good clinical and radiological results. Long-term follow-up studies are needed to confirm the current findings.

Uncoupled endoprostheses are characterized by satisfactory mobility, the ability to withstand high loads, and ligament structures are preserved during their implantation. Of the existing types of non-bonded endoprostheses, zirconium ceramics has a number of advantages, such as: good ingrowth ability, no wear, no rejection reactions. The main advantages of this type of surgical treatment are: rapid pain relief, improved function and stability, individual adaptation of prostheses. Endoprosthetics is recommended for patients of working age with high functional demands.

Thus, the development and implementation of new design solutions in clinical practice is relevant and promising.

task in the surgical treatment of patients with deforming osteoarthritis of the first metatarsophalangeal joint.

Purpose of the study:

To develop and introduce into clinical practice a new method of surgical treatment of patients with deforming osteoarthrosis of the first metatarsophalangeal joint using an anatomically adapted endoprosthesis.

详细描述

Relevance

The first metatarsophalangeal joint (MPJ) has an important function in the biomechanics of human gait, especially in the toe and thrust phases, as the full range of motion at this joint provides the body with smooth horizontal acceleration. The flattening of the arches of the foot and, as a result, the overload of its anterior section occupy a leading place in the etiology of deforming osteoarthritis (Hallux rigidus). Hallux rigidus is a disease associated with degenerative changes in the articular cartilage of the first metatarsophalangeal joint. The relevance of the treatment of arthrosis of the first metatarsophalangeal joint is determined by the high incidence and functional significance of the joint.

On average, this disease occurs, according to different authors, in 2.5-7.8% of the world population.

Hallux rigidus is a complex disease and numerous conservative and surgical treatments have been developed and described for its treatment. The doctor is faced with the difficult task of choosing an intervention method, for which it is necessary to pay attention to certain criteria: the degree of arthrosis, the age and level of activity of the patient, and the expectation of the result. Conservative treatment can lead to satisfactory performance in selected patients with grade 0 and grade I arthrosis of the first metatarsophalangeal joint with low functional requirements. In the middle stages of arthrosis, an isolated cheilectomy or osteotomy of the proximal phalanx and metatarsal bone is performed, which, despite their differences, for the most part does not lead to a significant increase in the range of motion in the joint. At the 3rd and 4th degrees of arthrosis, arthrodesis, resection arthroplasty and arthroplasty of the first metatarsophalangeal joint are used.

To date, the most optimal methods of surgical treatment of severe arthrosis of the first metatarsophalangeal joint are arthroplasty and arthrodesis of the joint. These operations are preferred because they achieve good clinical and radiological results. Long-term follow-up studies are needed to confirm the current information.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
52 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • idiopathic, post-traumatic and degenerative arthrosis of the first metatarsophalangeal joint
  • working age of patients

排除标准

  • purulent arthritis and osteomyelitis in the forefoot
  • severe osteoporosis
  • significant bone defect
  • trophic skin changes due to chronic vascular diseases

结局指标

主要结局

Dynamics of quality of life indicators using questionnaires

时间窗: 2 years

AOFAS scale (American Orthopaedic Foot and Ankle Society Score). The results of treatment are evaluated as follows: excellent - 95-100 points; good - 75-94 points; satisfactory - 51-74 points; bad - 50 points or less.

次要结局

  • Plantography and podometry(2 years)
  • clinical method(2 years)
  • X-ray method(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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