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

NCT05717413 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2024-04-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

metatarsophalangeal joint endoprosthesis

arthroplasty of 1 metatarsophalangeal joint

Sponsors & Collaborators

  • City Clinical Hospital No.1 named after N.I. Pirogov

    collaborator OTHER

  • Samara State Medical University

    lead OTHER

Eligibility

Min Age
52 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2025-07-01
Completion
2025-08-01

Countries

  • Russia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05717413 on ClinicalTrials.gov