Osteoarthritis of the KneeCAMERANCT06211465
Cardiovascular And Metabolic Risk After Arthroplasty
An observational study of Osteoarthritis of the Knee and Osteoarthritis of the Hip, run by University of Tartu at 1 site in Estonia.
Trial summary
Osteoarthritis is a chronic joint disease that lacks curative therapy. Epidemiological studies show increase in the burden of disease. Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Knee, Osteoarthritis of the Hip, Cardiovascular Diseases
- What is being tested?
- Total joint arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 152 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Mar 2014to Apr 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with primary osteoarthritis
Who may be able to join
- primary hip and knee OA (according to the American College of Rheumatology criteria) eligible for total joint arthroplasty
Who cannot join
- posttraumatic OA, infectious and endocrine related arthropathy, any acute or chronic inflammatory disease, malignancy, renal insufficiency (estimated glomerular filtration rate (eGFR) < 60ml/min/1.73m2), cardiac arrhythmia, clinically significant heart failure, valvular disease, diabetes.
- any concomitant acute or chronic inflammatory disease, a visit to family practitioner due to hip or knee joint complaints, any persistent knee or hip joint pain, diabetes, symptomatic coronary artery disease, cardiac arrhythmia, cerebrovascular or peripheral artery disease, malignancies and renal insufficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular And Metabolic Risk After Arthroplasty: the CAMERA Study
Osteoarthritis is a chronic joint disease that lacks curative therapy. Epidemiological studies show increase in the burden of disease. Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. However, the specific effects of total joint arthroplasty on cardiovascular risk and metabolic profile are largely unknown. The aim of this project is to elucidate how hip and knee total joint arthroplasty impacts cardiovascular risk and metabolomic profile in comparison with general population. We hypothesize that arthroplasty decreases pain, systemic inflammation levels and increases functional status that all lead to decreased metabolic and cardiovascular risk.
- Conditions
- Osteoarthritis of the Knee, Osteoarthritis of the Hip, Cardiovascular Diseases, Metabolic Syndrome
- Being tested
- Total joint arthroplasty
- Keywords
- metabolomics, arthroplasty, cardiovascular risk, arterial stiffness
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total joint arthroplastyProcedure or surgery
Hip or knee total joint arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with end-stage osteoarthritis (OA), who were eligible for total joint arthroplasty in Tartu University Hospital. Exclusion criteria: posttraumatic OA, infectious or endocrine arthropathy, acute or chronic inflammatory disease, malignancies, end-stage renal impairment (eGFR < 60ml/min/1.73m2), dysrhythmias, clinically relevant heart failure, heart valve-disease, diabetes. Receives: Procedure: Total joint arthroplasty | |
| Controls | Gender and age matched control group, who is recruited from the general practitioner (GP) list and who are from the same geographical regions as the cases. Excluding criteria: acute or chronic inflammatory disease, GP visitation due to hip or knee problems, persistent knee or hip pain, diabetes, symptomatic coronary disease, dysrhythmias, cerebrovascular or peripheral artery disease, malignancy or renal impairment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic pulse wave velocity at 5 years after arthroplasty
5 years after the beginning of study for control group; measurements are done using the Sphygmocor device.
Measured: 5 years
Secondary outcomes (14)
Changes in low-molecular weight metabolites
Low-molecular weight metabolites are measured using Biocrates Absolute IDQ p180 kit (BIOCRATES Life Sciences AG, Innsbruck, Austria), which enables to quantify lipides, acylcarnitines, aminoacids, biogenic amines, polyamides
Measured: 5 years
Oxidative stress index
Serum oxidative stress index. Expressed in %. The percentage of the ratio of total plasma peroxide concentration to plasma total antioxidative capacity (TAC, expressed in mmol trolox equivalent/L).
Measured: 5 years
Leptin levels
Measured from serum. Expressed in ng/ml.
Measured: 5 years
Metabolic syndrome risk score
A composite risk score is used to assess metabolic syndrome risk and include waist circumference(cm), HDL-cholesterol level(mmol/L), fasting glucose level(mmol/L), triglycerides level(mmol/L), blood pressure(mmHg). Each factor gives one point to the total score (range 0-5)
Measured: 5 years
Harris Hip score or Hospital for Special Surgery Knee score
Harris Hip Score for hip arthroplasty patients. The HHS is divided into three sections. The first section are questions about pain and its impact which are answered by the patient or client. The second and third sections require specialist to assess the patient or client's hip joint and function. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: 5 years
Central systolic blood pressure
Central systolic blood pressure is measured using the Sphygmocor device. Expressed in mmHg.
Measured: 5 years
Central diastolic blood pressure
Central diastolic blood pressure is measured using the Sphygmocor device. Expressed in mmHg.
Measured: 5 years
Composite of cardiovascular clinical events
Composite of stroke, myocardial infarction, cardiovascular death, unstable angina
Measured: 5 years
Oxidized LDL-cholesterol
Measured from serum. Expressed in mmol/L
Measured: 5 years
Adiponectin level
Measured from serum, expressed in ng/ml
Measured: 5 years
Augmentation index
Measured using the Sphygmocor device. The augmentation index (AI) is an indirect measure of arterial stiffness and increases with age, and it is calculated as AG (augmentation pressure) divided by PP(pulse pressure) ×100 to give a percentage.
Measured: 5 years
SF-36
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: 5 years
Hospital for Special Surgery knee score
The HSS Knee Score is based on a total of 100 points. The score is divided into seven categories, which include pain, function, range of motion, muscle strength, flexion deformity, instability, and subtractions. The knee is initially given a score of 0, and additions or subtractions are made according to specific criteria. The higher the score, the better the outcome. Approximately 50% of the score is based on a patient interview and the remaining on physical exam.
Measured: 5 years
Central pulse pressure
Measured using the Sphygmocor device. Expressed in mmHg.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Mar 2014
- Primary completionJan 2023
- Study completionApr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- Tartu University Hospital, Estonian Science Foundation
- Responsible party
- Principal investigator, Kaspar Tootsi, University of Tartu
- Investigators
- Kaspar Tootsi, PhD, MD, Principal investigator, University of TartuKadri Vilba, MD, Study chair, University of TartuAare Märtson, PhD, MD, Study chair, University of TartuJaak Kals, PhD, MD, Study chair, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211465
- Sponsor's protocol ID
- 296T-14
- Acronym
- CAMERA
- Status last verified
- Jan 2024
- First submitted
- 30 Dec 2020
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sober-Williams EK, Kilk K, Kals J, Martson A, Prommik P, Tootsi K. Longitudinal remodeling of acylcarnitine signatures before and after arthroplasty for osteoarthritis: A 7-year cohort study. Osteoarthritis Cartilage. 2026 Nov 3:S1063-4584(26)01119-2. doi: 10.1016/j.joca.2026.10.017. Online ahead of print.
PubMed 42976979
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular And Metabolic Risk After Arthroplasty: the CAMERA Study
- ClinicalTrials.gov ID
- NCT06211465
- Acronym / sponsor ID
- CAMERA / 296T-14
- Conditions
- Osteoarthritis of the Knee, Osteoarthritis of the Hip, Cardiovascular Diseases, Metabolic Syndrome
- Keywords
- metabolomics, arthroplasty, cardiovascular risk, arterial stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- Tartu University Hospital, Estonian Science Foundation
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- Jan 2023 (actual)
- Study completion
- Apr 2023 (actual)
- First posted
- 18 Jan 2024 (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.
Osteoarthritis is a chronic joint disease that lacks curative therapy. Epidemiological studies show increase in the burden of disease. Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. However, the specific effects of total joint arthroplasty on cardiovascular risk and metabolic profile are largely unknown. The aim of this project is to elucidate how hip and knee total joint arthroplasty impacts cardiovascular risk and metabolomic profile in comparison with general population. We hypothesize that arthroplasty decreases pain, systemic inflammation levels and increases functional status that all lead to decreased metabolic and cardiovascular risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Procedure: Total joint arthroplastyPatients with end-stage osteoarthritis (OA), who were eligible for total joint arthroplasty in Tartu University Hospital. Exclusion criteria: posttraumatic OA, infectious or endocrine arthropathy, acute or chronic inflammatory disease, malignancies, end-stage renal impairment (eGFR < 60ml/min/1.73m2), dysrhythmias, clinically relevant heart failure, heart valve-disease, diabetes. |
| Controls | – | –Gender and age matched control group, who is recruited from the general practitioner (GP) list and who are from the same geographical regions as the cases. Excluding criteria: acute or chronic inflammatory disease, GP visitation due to hip or knee problems, persistent knee or hip pain, diabetes, symptomatic coronary disease, dysrhythmias, cerebrovascular or peripheral artery disease, malignancy or renal impairment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with primary osteoarthritis
Key inclusion criteria (1 listed)
- primary hip and knee OA (according to the American College of Rheumatology criteria) eligible for total joint arthroplasty
Key exclusion criteria (2 listed)
- posttraumatic OA, infectious and endocrine related arthropathy, any acute or chronic inflammatory disease, malignancy, renal insufficiency (estimated glomerular filtration rate (eGFR) < 60ml/min/1.73m2), cardiac arrhythmia, clinically significant heart failure, valvular disease, diabetes.
- any concomitant acute or chronic inflammatory disease, a visit to family practitioner due to hip or knee joint complaints, any persistent knee or hip joint pain, diabetes, symptomatic coronary artery disease, cardiac arrhythmia, cerebrovascular or peripheral artery disease, malignancies and renal insufficiency.
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 |
|---|---|---|
| Total joint arthroplastyHip or knee total joint arthroplasty | Procedure or surgery | Cases |
Primary outcome
Aortic pulse wave velocity at 5 years after arthroplasty
Time frame: 5 years
5 years after the beginning of study for control group; measurements are done using the Sphygmocor device.
14 secondary outcomes
Changes in low-molecular weight metabolites
Time frame: 5 years
Oxidative stress index
Time frame: 5 years
Leptin levels
Time frame: 5 years
Metabolic syndrome risk score
Time frame: 5 years
Harris Hip score or Hospital for Special Surgery Knee score
Time frame: 5 years
Central systolic blood pressure
Time frame: 5 years
Central diastolic blood pressure
Time frame: 5 years
Composite of cardiovascular clinical events
Time frame: 5 years
Oxidized LDL-cholesterol
Time frame: 5 years
Adiponectin level
Time frame: 5 years
Augmentation index
Time frame: 5 years
SF-36
Time frame: 5 years
Hospital for Special Surgery knee score
Time frame: 5 years
Central pulse pressure
Time frame: 5 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 18 Jan 2024.
- Derived from this study: PubMed 42976979Sober-Williams EK, Kilk K, Kals J, Martson A, Prommik P, Tootsi K. Longitudinal remodeling of acylcarnitine signatures before and after arthroplasty for osteoarthritis: A 7-year cohort study. Osteoarthritis Cartilage. 2026 Nov 3:S1063-4584(26)01119-2. doi: 10.1016/j.joca.2026.10.017. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Kaspar Tootsi, PhD, MD principal investigator
University of Tartu
Kadri Vilba, MD study chair
University of Tartu
Aare Märtson, PhD, MD study chair
University of Tartu
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 of the Knee and Osteoarthritis of the Hip, run by University of Tartu at 1 site in Estonia.
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 2 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 18 Jan 2024. 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 Estonia. 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?
Aortic pulse wave velocity at 5 years after arthroplasty (time frame: 5 years). 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 NCT06211465, which also lists 1 linked publication.
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 18 Jan 2024.