Knee OsteoarthritisNCT05749601

Risk Factor Involved in Knee Osteoarthritis (KOA)

A study testing Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid, The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis and The influence of ROS from the synovial fluid on the severity of KOA in people with Knee Osteoarthritis, run by Iacob Czihac Emergency Military Clinical Hospital at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Clinical study regarding the incidence and severity of knee osteoarthritis (KOA) in a certain area from South-Eastern Europe. Aim of the clinical study: to determine the KOA grade through X-Ray studies, to perform nuclear magnetic resonance (NMR) analysis to assess the KOA severity and to determine the level of… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid, The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis and The influence of ROS from the synovial fluid on the severity of KOA
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 1 siteRomania
Study dates: 1 Mar 2022to 19 Aug 2022
Phase: Interventional
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

male and female with knee pain (complaints); presented symptoms and clinical signs corresponding to KOA and had knee X-rays in the anteroposterior view and nuclear magnetic resonance (NMR) performed for setting the diagnosis with unilateral or bilateral knee pain; patients with clinically determined and recorded values of total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and the glycemia in the clinical observation sheet.

Who cannot join

patients presenting lower limb arthroplasties; history of lower limb or pelvis fractures and previous knee surgery: ligamentoplasty, meniscectomy; inflammatory rheumatic diseases such as rheumatoid polyarthritis; other major conditions like malignant illness.

Trial locations and contacts

1 site in 1 country.

Romania1 site

3 "Iacob Czihac" Emergency Military Clinical Hospital, 7-9 General Henri Mathias Berthelot St., 700483 Iasi, Romania
Iași

Other trials in Romania

About this study

Official title: Study of Anatomical and Imaging Characteristics in Relation With the Risk Factors Involved in KOA Progression

Read the detailed description

Clinical study regarding the incidence and severity of KOA in a certain area from South-Eastern Europe. Clinical study on 85 patients out 373 participants that were screened, chosen based on inclusion/exclusion criteria.

Aim of the clinical study: to determine the KOA grade through X-Ray studies, to perform nuclear magnetic resonance (NRM) analysis to assess the KOA severity. Data corroboration of the KOA degree with the results of the blood samples analysis, looking for the influence of the metabolic syndrome (MetS) parameters - high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides, glycemia, and then the body mass index (BMI). In the meantime, there is intended to associate the environment of origin of the patients from the trial group with the KOA incidence and severity. To determine the level of significant parameters in the synovial liquid extracted from the patients presenting KOA, analysis of the degradation products present in the synovial fluid of patients with KOA, such as free radicals, like reactive oxygen species (ROS) and reactive nitrogen species (RNS) and their influence on the severity of the pathology.

Conditions: Knee Osteoarthritis
Being tested: Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid, The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis, The influence of ROS from the synovial fluid on the severity of KOA
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluidOther
Highlighting the influence of environment of origin on KOA incidence and corelated impact of high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides and body mass index (BMI). The analytes from synovial fluid were determined by fluorometric method.
The influence of patellofemoral morphology in the radiological severity of knee osteoarthritisOther
Highlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.
The influence of ROS from the synovial fluid on the severity of KOAOther
Highlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.

Study groups in NCT05749601
Study group	Role	What they receive
Patients without knee osteoarthritis (KOA) grade 0	Active comparator	Patient without knee affection Receives: Other: Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid; Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis; Other: The influence of ROS from the synovial fluid on the severity of KOA
Patients with KOA grade I	Experimental	Kellgren-Lawrence classification (KL) grade I- doubtful narrowing of the joint space and possible osteophytes Receives: Other: Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid; Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis; Other: The influence of ROS from the synovial fluid on the severity of KOA
Patients with KOA grade II	Experimental	KL grade II - definite osteophytes and possible narrowing of joint space. Receives: Other: Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid; Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis; Other: The influence of ROS from the synovial fluid on the severity of KOA
Patients with KOA grade III	Experimental	KL grade III- definite narrowing of the joint space, significant osteophytosis, and possible bone deformities. Receives: Other: Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid; Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis; Other: The influence of ROS from the synovial fluid on the severity of KOA
Patients with KOA grade IV	Experimental	KL grade IV- marked joint space narrowing accompanied by deformities, bone sclerosis, and large osteophytes Receives: Other: Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid; Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis; Other: The influence of ROS from the synovial fluid on the severity of KOA

What is being measured

The primary outcome is the main question the study is designed to answer.

The influence of metabolic syndrome parametres and environment of origin in KOA severity
In this part of the study I included 85 patients for whom I measure the parameters of the metabolic syndrome: a high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglyceride, total cholesterol and body mass index (BMI) and I made the corelation of knee osteoarthritis (KOA) Kellgren-Lawrence radiological classification (KL). The formula form BMI was kg/ m2. I raported the influence of the environment of origin in relation to the severity of KOA, performing the statistical analysis of the obtained data, applied metod ANOVA, specific ordinal and binomial logistic regression models, p value <0,005. 95% confidence interval, without non-inferiority/equivalence test.
Measured: up 2 weeks

Secondary outcomes (1)

The influence of patellofemoral morphology in KOA severity
I measured distal femoral torsion angle, patellofemoral congruence angle and sulcus angle for 43 patients who had NRM examinations and I raported their impact in KOA severity under the influence of sex and age.
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202219 Aug 2022

First posted1 Mar 2023
Study start1 Mar 2022
Primary completion16 Jun 2022
Study completion19 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Knee 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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05749601
Sponsor's protocol ID: 10/A575
Status last verified: Mar 2023
First submitted: 19 Oct 2022
Last updated: 3 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Anatomical and Imaging Characteristics in Relation With the Risk Factors Involved in KOA Progression
ClinicalTrials.gov ID: NCT05749601
Acronym / sponsor ID: 10/A575
Conditions: Knee Osteoarthritis
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: Iacob Czihac Emergency Military Clinical HospitalResearch network
Study start: 1 Mar 2022 (actual)
Primary completion: 16 Jun 2022 (actual)
Study completion: 19 Aug 2022 (actual)
First posted: 1 Mar 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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Patients without knee osteoarthritis (KOA) grade 0	Active comparator	Other: Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid, Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis, Other: The influence of ROS from the synovial fluid on the severity of KOAPatient without knee affection
Patients with KOA grade I	Experimental	Other: Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid, Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis, Other: The influence of ROS from the synovial fluid on the severity of KOAKellgren-Lawrence classification (KL) grade I- doubtful narrowing of the joint space and possible osteophytes
Patients with KOA grade II	Experimental	Other: Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid, Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis, Other: The influence of ROS from the synovial fluid on the severity of KOAKL grade II - definite osteophytes and possible narrowing of joint space.
Patients with KOA grade III	Experimental	Other: Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid, Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis, Other: The influence of ROS from the synovial fluid on the severity of KOAKL grade III- definite narrowing of the joint space, significant osteophytosis, and possible bone deformities.
Patients with KOA grade IV	Experimental	Other: Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluid, Other: The influence of patellofemoral morphology in the radiological severity of knee osteoarthritis, Other: The influence of ROS from the synovial fluid on the severity of KOAKL grade IV- marked joint space narrowing accompanied by deformities, bone sclerosis, and large osteophytes

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

male and female with knee pain (complaints); presented symptoms and clinical signs corresponding to KOA and had knee X-rays in the anteroposterior view and nuclear magnetic resonance (NMR) performed for setting the diagnosis with unilateral or bilateral knee pain; patients with clinically determined and recorded values of total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides and the glycemia in the clinical observation sheet.

Key exclusion criteria (1 listed)

patients presenting lower limb arthroplasties; history of lower limb or pelvis fractures and previous knee surgery: ligamentoplasty, meniscectomy; inflammatory rheumatic diseases such as rheumatoid polyarthritis; other major conditions like malignant illness.

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
Influence of the metabolic syndrome (MetS) parameters on knee osteoarthritis (KOA) severity, the assesment of the reactive oxygen species and reactive nitrogen species in knee synovial fluidHighlighting the influence of environment of origin on KOA incidence and corelated impact of high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides and body mass index (BMI). The analytes from synovial fluid were determined by fluorometric method.	Other	Patients with KOA grade I, Patients with KOA grade II, Patients with KOA grade III, Patients with KOA grade IV, Patients without knee osteoarthritis (KOA) grade 0
The influence of patellofemoral morphology in the radiological severity of knee osteoarthritisHighlighting the influence of distal femoral torsion angle, patellofemoral congruence angle and sulcus angle, in KOA severity under the influence of sex and age.	Other	Patients with KOA grade I, Patients with KOA grade II, Patients with KOA grade III, Patients with KOA grade IV, Patients without knee osteoarthritis (KOA) grade 0
The influence of ROS from the synovial fluid on the severity of KOAHighlighting the influence of ROS from the synovial fluid in KOA severity under the influence of some biochemicals blood constants.	Other	Patients with KOA grade I, Patients with KOA grade II, Patients with KOA grade III, Patients with KOA grade IV, Patients without knee osteoarthritis (KOA) grade 0

Primary outcome

The influence of metabolic syndrome parametres and environment of origin in KOA severity
Time frame: up 2 weeks
In this part of the study I included 85 patients for whom I measure the parameters of the metabolic syndrome: a high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglyceride, total cholesterol and body mass index (BMI) and I made the corelation of knee osteoarthritis (KOA) Kellgren-Lawrence radiological classification (KL). The formula form BMI was kg/ m2. I raported the influence of the environment of origin in relation to the severity of KOA, performing the statistical analysis of the obtained data, applied metod ANOVA, specific ordinal and binomial logistic regression models, p value <0,005. 95% confidence interval, without non-inferiority/equivalence test.

1 secondary outcome

The influence of patellofemoral morphology in KOA severity
Time frame: 1 week

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 3 Mar 2023.
Individual participant dataSharing planned: No

Related trials for Knee Osteoarthritis

Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
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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.

Nicoleta B Tudorachi, MD principal investigator

"Ovidius" University of Constanța, Romania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 3 Mar 2023. 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 Romania. 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?

The influence of metabolic syndrome parametres and environment of origin in KOA severity (time frame: up 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05749601.

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 3 Mar 2023.