OsteoarthritisNCT05717413
New Method of Surgical Treatment of Patients With Osteoarthritis of the 1st Metatarsophalangeal Joint
An observational study of Osteoarthritis, run by Samara State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 52 to 69 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- metatarsophalangeal joint endoprosthesis
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2022to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 52 to 69 years
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- idiopathic, post-traumatic and degenerative arthrosis of the first metatarsophalangeal joint
- working age of patients
Who cannot join
- purulent arthritis and osteomyelitis in the forefoot
- severe osteoporosis
- significant bone defect
- trophic skin changes due to chronic vascular diseases
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
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.
Research objectives:
- To evaluate the results of surgical treatment of patients with deforming osteoarthritis of the first metatarsophalangeal joint based on standard approaches.
- To develop an anatomically adapted all-ceramic endoprosthesis of the first metatarsophalangeal joint.
- To develop an algorithm for installing a metatarsophalangeal joint endoprosthesis on cadaveric material and the corresponding special tools.
- Develop specifications for the serial use of the endoprosthesis, including modes of sterilization, packaging and operation.
- To develop a mode of motor activity in the early postoperative period after the installation of the endoprosthesis of the first metatarsophalangeal joint
- Conduct a comparative analysis of the mid-term results of the standard and new method of surgical treatment of patients with deforming osteoarthritis of the first metatarsophalangeal joint using the principles of evidence-based medicine.
- To introduce into clinical practice a new method of surgical treatment of patients with deforming osteoarthrosis of the first metatarsophalangeal joint using anatomically adapted arthroplasty.
Scientific novelty:
For the first time, an anatomically adapted all-ceramic two-component endoprosthesis of the first metatarsophalangeal joint was developed based on the analysis of clinical material and engineering tests.
For the first time, an algorithm for installing an anatomically adapted endoprosthesis of the first metatarsophalangeal joint with the necessary range of surgical special instruments has been developed.
For the first time, a mode of motor activity was developed in the early postoperative period, based on a study of the biomechanics of the first metatarsophalangeal joint after arthroplasty.
For the first time, the advantage of a new method of surgical treatment of patients with arthrosis of the first metatarsophalangeal joint was substantiated using the principles of evidence-based medicine compared to standard methods.
Specifications for the serial use of the endoprosthesis of the first metatarsophalangeal joint in clinical practice have been developed.
A new method of surgical treatment of patients with deforming arthrosis of the first metatarsophalangeal joint has been introduced into clinical practice
Planned scope of research:
- To assess the mid-term results of surgical treatment of patients with arthrosis of the first metatarsophalangeal joint on the basis of the departments of traumatology and orthopedics of the Clinic 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 and Orthopedics of CB "RZD-Medicine".
- To develop a new anatomically adapted all-ceramic endoprosthesis of the first metatarsophalangeal joint.
- On the basis of the Samara Regional Bureau of Forensic Medical Examination, develop a method for installing the endoprosthesis of the first metatarsophalangeal joint on cadaveric material.
- Using a set of studies (clinical, radiological, subometric, plantographic) to give a structural and functional description of the surgical treatment of patients with arthrosis of the first metatarsophalangeal joint in the medium-term postoperative period.
- To compare the mid-term results of the standard and new method of surgical treatment of patients with deforming osteoarthritis of the first metatarsophalangeal joint using the principles of evidence-based medicine.
Object and methods of research:
The object of the study - patients aged 45 to 70 years. Clinical work will be carried out on the basis of 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 and Orthopedics of CB "RZD-Medicine". Research work will be carried out using radiation, functional and clinical research methods. It is planned to distribute patients into two groups: control and main. Both groups were comparable in terms of sex, age and duration of the disease. All data will be statistically processed and evaluated from the standpoint of 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. A mathematical model and an integral indicator will be built to evaluate the results of surgical treatment.
Expected results:
A new method of surgical treatment of patients with osteoarthritis of the 1st metatarsophalangeal joint will be developed.
A mode of motor activity will be developed in the early postoperative period, based on a study of the biomechanics of the 1st metatarsophalangeal joint after arthroplasty A method for installing an endoprosthesis of the 1st metatarsophalangeal joint will be developed A mathematical model will be built to evaluate the results of treatment of patients with arthrosis of the first metatarsophalangeal joint.
- Conditions
- Osteoarthritis
- Being tested
- metatarsophalangeal joint endoprosthesis
- Keywords
- modeling of critical loads, geometric model of the foot, Endoprosthesis of 1 metatarsophalangeal joint
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metatarsophalangeal joint endoprosthesisDevice
arthroplasty of 1 metatarsophalangeal joint
| Study group | Role | What they receive |
|---|---|---|
| Patients after arthroplasty of the 1st metatarsophalangeal joint | Not described Receives: Device: metatarsophalangeal joint endoprosthesis | |
| Patients after arthrodesis of the 1st metatarsophalangeal joint | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
clinical method
Visual examination, range of motion in the 1st metatarsophalangeal joint, palpation under the heads of the metatarsal bones to identify painful areas
Measured: 2 years
X-ray method
measurement and evaluation of the main x-ray indicators necessary for choosing the method of surgical intervention on the foot, determining the main angles of the foot
Measured: 2 years
Plantography and podometry
determination of the load distribution on the plantar surface of the foot after surgery.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Sep 2022
- Primary completion1 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samara State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- City Clinical Hospital No.1 named after N.I. Pirogov
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717413
- Sponsor's protocol ID
- 34
- Status last verified
- Oct 2026
- First submitted
- 28 Jan 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Method of Surgical Treatment of Patients With Osteoarthritis of the 1st Metatarsophalangeal Joint
- ClinicalTrials.gov ID
- NCT05717413
- Acronym / sponsor ID
- 34
- Conditions
- Osteoarthritis
- Keywords
- modeling of critical loads, geometric model of the foot, Endoprosthesis of 1 metatarsophalangeal joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Samara State Medical UniversityUniversity, hospital or other
- Collaborators
- City Clinical Hospital No.1 named after N.I. Pirogov
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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.
Research objectives:
- To evaluate the results of surgical treatment of patients with deforming osteoarthritis of the first metatarsophalangeal joint based on standard approaches.
- To develop an anatomically adapted all-ceramic endoprosthesis of the first metatarsophalangeal joint.
- To develop an algorithm for installing a metatarsophalangeal joint endoprosthesis on cadaveric material and the corresponding special tools.
- Develop specifications for the serial use of the endoprosthesis, including modes of sterilization, packaging and operation.
- To develop a mode of motor activity in the early postoperative period after the installation of the endoprosthesis of the first metatarsophalangeal joint
- Conduct a comparative analysis of the mid-term results of the standard and new method of surgical treatment of patients with deforming osteoarthritis of the first metatarsophalangeal joint using the principles of evidence-based medicine.
- To introduce into clinical practice a new method of surgical treatment of patients with deforming osteoarthrosis of the first metatarsophalangeal joint using anatomically adapted arthroplasty.
Scientific novelty:
For the first time, an anatomically adapted all-ceramic two-component endoprosthesis of the first metatarsophalangeal joint was developed based on the analysis of clinical material and engineering tests.
For the first time, an algorithm for installing an anatomically adapted endoprosthesis of the first metatarsophalangeal joint with the necessary range of surgical special instruments has been developed.
For the first time, a mode of motor activity was developed in the early postoperative period, based on a study of the biomechanics of the first metatarsophalangeal joint after arthroplasty.
For the first time, the advantage of a new method of surgical treatment of patients with arthrosis of the first metatarsophalangeal joint was substantiated using the principles of evidence-based medicine compared to standard methods.
Specifications for the serial use of the endoprosthesis of the first metatarsophalangeal joint in clinical practice have been developed.
A new method of surgical treatment of patients with deforming arthrosis of the first metatarsophalangeal joint has been introduced into clinical practice
Planned scope of research:
- To assess the mid-term results of surgical treatment of patients with arthrosis of the first metatarsophalangeal joint on the basis of the departments of traumatology and orthopedics of the Clinic 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 and Orthopedics of CB "RZD-Medicine".
- To develop a new anatomically adapted all-ceramic endoprosthesis of the first metatarsophalangeal joint.
- On the basis of the Samara Regional Bureau of Forensic Medical Examination, develop a method for installing the endoprosthesis of the first metatarsophalangeal joint on cadaveric material.
- Using a set of studies (clinical, radiological, subometric, plantographic) to give a structural and functional description of the surgical treatment of patients with arthrosis of the first metatarsophalangeal joint in the medium-term postoperative period.
- To compare the mid-term results of the standard and new method of surgical treatment of patients with deforming osteoarthritis of the first metatarsophalangeal joint using the principles of evidence-based medicine.
Object and methods of research:
The object of the study - patients aged 45 to 70 years. Clinical work will be carried out on the basis of 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 and Orthopedics of CB "RZD-Medicine". Research work will be carried out using radiation, functional and clinical research methods. It is planned to distribute patients into two groups: control and main. Both groups were comparable in terms of sex, age and duration of the disease. All data will be statistically processed and evaluated from the standpoint of 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. A mathematical model and an integral indicator will be built to evaluate the results of surgical treatment.
Expected results:
A new method of surgical treatment of patients with osteoarthritis of the 1st metatarsophalangeal joint will be developed.
A mode of motor activity will be developed in the early postoperative period, based on a study of the biomechanics of the 1st metatarsophalangeal joint after arthroplasty A method for installing an endoprosthesis of the 1st metatarsophalangeal joint will be developed A mathematical model will be built to evaluate the results of treatment of patients with arthrosis of the first metatarsophalangeal joint.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients after arthroplasty of the 1st metatarsophalangeal joint | – | Device: metatarsophalangeal joint endoprosthesis |
| Patients after arthrodesis of the 1st metatarsophalangeal joint | – | – |
Who may qualify
- Ages
- 52 to 69 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- idiopathic, post-traumatic and degenerative arthrosis of the first metatarsophalangeal joint
- working age of patients
Key exclusion criteria (4 listed)
- purulent arthritis and osteomyelitis in the forefoot
- severe osteoporosis
- significant bone defect
- trophic skin changes due to chronic vascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metatarsophalangeal joint endoprosthesisarthroplasty of 1 metatarsophalangeal joint | Device | Patients after arthroplasty of the 1st metatarsophalangeal joint |
Primary outcome
Dynamics of quality of life indicators using questionnaires
Time frame: 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.
3 secondary outcomes
clinical method
Time frame: 2 years
X-ray method
Time frame: 2 years
Plantography and podometry
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Samara State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamics of quality of life indicators using questionnaires (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.