New Method of Surgical Treatment of Patients With Osteoarthritis of the 1st Metatarsophalangeal Joint
1 other identifier
observational
46
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 28, 2023
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedApril 23, 2024
December 1, 2023
2.8 years
January 28, 2023
April 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dynamics of quality of life indicators using questionnaires
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.
2 years
Secondary Outcomes (3)
clinical method
2 years
X-ray method
2 years
Plantography and podometry
2 years
Study Arms (2)
Patients after arthroplasty of the 1st metatarsophalangeal joint
Patients after arthrodesis of the 1st metatarsophalangeal joint
Interventions
arthroplasty of 1 metatarsophalangeal joint
Eligibility Criteria
The object of the study - patients aged 45 to 70 years. Clinical work will be carried out in the departments of traumatology and orthopedics of the Clinics of the Samara State Medical University, the trauma department of the State Clinical Hospital No. 1 named after N.I. Pirogov and the Department of Traumatology of CB "RZD-Medicine". Research work includes radiation, functional and clinical research methods. Patients will be divided the control and main groups. Both groups were comparable in terms of sex, age, duration of the disease. All data will be statistically processed according to evidence-based medicine. Comparison of functional outcomes will be conducted using the American Association of Foot and Ankle Orthopedics (AOFAS) Clinical Assessment Scale for Foot and Ankle Diseases.
You may qualify if:
- idiopathic, post-traumatic and degenerative arthrosis of the first metatarsophalangeal joint
- working age of patients
You may not qualify if:
- purulent arthritis and osteomyelitis in the forefoot
- severe osteoporosis
- significant bone defect
- trophic skin changes due to chronic vascular diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinics of Samara State Medical University
Samara, 443079, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2023
First Posted
February 8, 2023
Study Start
September 1, 2022
Primary Completion
July 1, 2025
Study Completion
August 1, 2025
Last Updated
April 23, 2024
Record last verified: 2023-12