Knee OsteoarthritisAPPROACHNCT03883568
A 2-year, European Multicentre Study to Describe, Validate, and Predict Phenotypes of Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by F.P.J.G. Lafeber at 5 sites in 4 countries.
Trial summary
Rationale: Despite a large and growing disease burden in osteoarthritis (OA), many pharmaceutical companies have abandoned OA drug development. This is mainly due to the lack of appropriate outcome measures that can robustly identify patients that can benefit from a specific therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 297 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 19 Jan 2018to 1 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tibiofemoral knee osteoarthritis, according to the clinical ACR classification criteria, pre-identified based on demographic (e.g. age), clinical (e.g. Pain NRS) and tissue structure (e.g. radiographic joint space width) parameters.
Who may be able to join
- Informed consent obtained.
- Ambulatory (able to walk unassisted)
- At least 18 years of age
- Capable of understanding the study
- Capable of writing and reading in local language
- Predominantly tibiofemoral knee osteoarthritis and satisfy the clinical classification criteria of the American College of Rheumatology (ACR): Knee pain and three of the following criteria: over 50 years age, less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness, bony enlargement, or no palpable warmth.
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- Highest probability to progress based on the algorithm based on the following parameters:
- Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
- BMI (in recording height and weight)
- Pain NRS of the index knee at the moment of the screening visit
- Pain NRS of the index knee during the last week before the screening visit
- Age
- Gender
- KIDA parameters of the index knee, based on standardized weight-bearing (KIDA) radiograph, measured < 3 months (patients with a Joint Space Width (JSW) < 2 mm of the index knee will not be included)
Who cannot join
- Not being able to comply to the protocol
- Participating in a trial with local therapeutic intervention for index knee OA (pharmaceutical or surgical) or systemic Disease Modifying OsteoArthritic Drugs (DMOADs) or potential DMOADs treatments for OA at the same time or within the past 6 months or anticipated in the forthcoming; participation in non-interventional registries or epidemiological studies is allowed.
- Surgery of the index knee in the past 6 months (to avoid interferences with imaging)
- Scheduled or expected surgery of the index knee in the next 2 years (to avoid interferences with imaging)
- Pregnancy (child bearing woman) because of imaging (radiation and MRI, risks)
- Predominantly patellar femoral knee OA (clinical judgment)
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- The following secondary osteoarthritis of the knee: clinically significant deformities of the lower limbs (varus >10°, valgus >10°), septic arthritis, inflammatory joint disease, gout, major chondrocalcinosis (pseudogout), Paget's disease of the bone, ochronosis, acromegaly, haemochromatosis, Wilson's disease, rheumatic symptoms due to malignancies, primary osteochondromatosis, osteonecrosis, osteochondritis dissecans, haemophilia
- Generalized pain syndrome, for example fibromyalgia
- Patients with contra indication to MRI or CT
- Hip replacement or expected hip replacement within 6 months
- Osteosynthesis material near the knee joint
- Self-reported severe Intervertebral disc (IVD) degeneration or facet OA
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Netherlands2 sites
Leiden University Medical Center
Leiden
UMC Utrecht
Utrecht, 3584 CX
About this study
Official title: A 2-year Multicentre, EU, Exploratory Study Without Therapeutic Benefit in Patients With Knee Osteoarthritis to Describe, Validate, and Predict Phenotypes of Knee Osteoarthritis by Use of Clinical, Imaging, and Biochemical (Bio)Markers.
Rationale: Despite a large and growing disease burden in osteoarthritis (OA), many pharmaceutical companies have abandoned OA drug development. This is mainly due to the lack of appropriate outcome measures that can robustly identify patients that can benefit from a specific therapy. Different phenotypes of OA may benefit from different types of treatment. Therefore, novel markers to identify selected phenotypes of osteoarthritis may encourage drug development.
Objective: To prospectively describe in detail pre-identified progressing phenotypes of patients with knee OA by use of conventional and novel clinical, imaging, and biochemical (bio)markers, and to validate and refine a predictive model for these (and new) progressing phenotypes based on these markers.
Read more
Study design: APPROACH is an exploratory, European, five-centre, 2-year prospective follow-up, cohort study, with extensive measurements. In this study patients are treated according to regular care by their own physician with no study related treatment prescribed. Study related diagnostic and/or monitoring procedures are applied to the patients.
Study population: Patients with tibiofemoral knee osteoarthritis, according to the clinical ACR classification criteria, pre-identified based on demographic (e.g. age), clinical (e.g. Pain NRS) and tissue structure (e.g. radiographic joint space width) parameters.
Main study parameters/endpoints: Joint tissue structure based on radiographs, MRI, and biochemical (bio)markers as well as symptoms (pain, function) and quality of life by questionnaires.
Secondary parameters: A multitude of (novel and conventional) clinical, imaging, and biochemical parameters related to osteoarthritis.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participants will not have any direct benefit from their participation in this study other than that their OA is maximally diagnosed and followed in detail for up to 2 years (screening, baseline, 6 months, 12 months, 24 months).
Read the detailed description
Patients will stay in the hospital for 4-5 hours per visit (for screening about 30 min) for physical examination, blood draw, MRI scans, radiographs of knees and hands (only at baseline and 24 months), CT scan of the knee (only at baseline and 24 months), low radiation whole body CT scan (only at baseline and 24 months), HandScan (only at baseline and 24 months), motion analysis, and performance based tests. They will be asked to fill out questionnaires about knee, hand and hip osteoarthritis, and about general health and pain. The patient council in the consortium indicated that the load is acceptable. The patient council will be involved in the execution of the study. The assumed risk is minimal for an individual patient and minimal compared to the contribution to the development of knowledge of their disease. These risks include minimal events due to blood sampling itself (such as hematoma or localized bleeding), radiation exposure by radiographic imaging techniques (with a minimal increased healthcare risk), and exposure to MRI techniques (without known risks and without use of contrast agents).
- Conditions
- Knee Osteoarthritis
- Keywords
- phenotypes, (bio)markers
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
OA structural progression of the index knee
radiographic joint space width in mm
Measured: over two years
OA pain progression of the index knee
increase in points in Knee Osteoarthritis Outcome Score for pain (0-100; 0 worst, 100 best condition)
Measured: over two years
Secondary outcomes (2)
OA progression of the index knee
structural progression (e.g. cartilage volume on MRI in mm3)
Measured: over two years
OA progression
structural progression (biochemical markers in units/ml in blood and urine)
Measured: over two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start19 Jan 2018
- Primary completion3 Apr 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- F.P.J.G. Lafeber
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Nordic Bioscience A/S, University of Surrey, Leiden University Medical Center, Complexo Hospitalario Universitario de A Coruña, Institut de Recherches Internationales Servier, Newcastle University, Merck KGaA, Darmstadt, Germany, Diakonhjemmet Hospital, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor-investigator, F.P.J.G. Lafeber, UMC Utrecht
- Investigators
- Floris PJ Lafeber, PhD, Study director, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883568
- Sponsor's protocol ID
- APPROACH-OA-P01
- Acronym
- APPROACH
- Status last verified
- May 2022
- First submitted
- 3 Jul 2018
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jansen MP, Wirth W, Bacardit J, van Helvoort EM, Marijnissen ACA, Kloppenburg M, Blanco FJ, Haugen IK, Berenbaum F, Ladel CH, Loef M, Lafeber FPJG, Welsing PM, Mastbergen SC, Roemer FW. Machine-learning predicted and actual 2-year structural progression in the IMI-APPROACH cohort. Quant Imaging Med Surg. 2023 May 1;13(5):3298-3306. doi: 10.21037/qims-22-949. Epub 2023 Mar 10.
PubMed 37179936Brett A, Bowes MA, Conaghan PG. Comparison of 3D quantitative osteoarthritis imaging biomarkers from paired CT and MR images: data from the IMI-APPROACH study. BMC Musculoskelet Disord. 2023 Jan 30;24(1):76. doi: 10.1186/s12891-023-06187-2.
PubMed 36710346Roemer FW, Jansen M, Marijnissen ACA, Guermazi A, Heiss R, Maschek S, Lalande A, Blanco FJ, Berenbaum F, van de Stadt LA, Kloppenburg M, Haugen IK, Ladel CH, Bacardit J, Wisser A, Eckstein F, Lafeber FPJG, Weinans HH, Wirth W. Structural tissue damage and 24-month progression of semi-quantitative MRI biomarkers of knee osteoarthritis in the IMI-APPROACH cohort. BMC Musculoskelet Disord. 2022 Nov 17;23(1):988. doi: 10.1186/s12891-022-05926-1.
PubMed 36397054Wirth W, Maschek S, Marijnissen ACA, Lalande A, Blanco FJ, Berenbaum F, van de Stadt LA, Kloppenburg M, Haugen IK, Ladel CH, Bacardit J, Wisser A, Eckstein F, Roemer FW, Lafeber FPJG, Weinans HH, Jansen M. Test-retest precision and longitudinal cartilage thickness loss in the IMI-APPROACH cohort. Osteoarthritis Cartilage. 2023 Feb;31(2):238-248. doi: 10.1016/j.joca.2022.10.015. Epub 2022 Nov 3.
PubMed 36336198van Helvoort EM, Jansen MP, Marijnissen ACA, Kloppenburg M, Blanco FJ, Haugen IK, Berenbaum F, Bay-Jensen AC, Ladel C, Lalande A, Larkin J, Loughlin J, Mobasheri A, Weinans HH, Widera P, Bacardit J, Welsing PMJ, Lafeber FPJG. Predicted and actual 2-year structural and pain progression in the IMI-APPROACH knee osteoarthritis cohort. Rheumatology (Oxford). 2022 Dec 23;62(1):147-157. doi: 10.1093/rheumatology/keac292.
PubMed 35575381Angelini F, Widera P, Mobasheri A, Blair J, Struglics A, Uebelhoer M, Henrotin Y, Marijnissen AC, Kloppenburg M, Blanco FJ, Haugen IK, Berenbaum F, Ladel C, Larkin J, Bay-Jensen AC, Bacardit J. Osteoarthritis endotype discovery via clustering of biochemical marker data. Ann Rheum Dis. 2022 May;81(5):666-675. doi: 10.1136/annrheumdis-2021-221763. Epub 2022 Mar 4.
PubMed 35246457van Helvoort EM, Welsing PMJ, Jansen MP, Gielis WP, Loef M, Kloppenburg M, Blanco F, Haugen IK, Berenbaum F, Bay-Jensen AC, Ladel C, Lalande A, Larkin J, Loughlin J, Mobasheri A, Weinans H, Lafeber F, Eijkelkamp N, Mastbergen S. Neuropathic pain in the IMI-APPROACH knee osteoarthritis cohort: prevalence and phenotyping. RMD Open. 2021 Dec;7(3):e002025. doi: 10.1136/rmdopen-2021-002025.
PubMed 34911812Taylor J, Dekker S, Jurg D, Skandsen J, Grossman M, Marijnissen AK, Ladel C, Mobasheri A, Larkin J, Weinans H, Kanter-Schlifke I; APPROACH research consortium and APPROACH Principal Investigators. Making the patient voice heard in a research consortium: experiences from an EU project (IMI-APPROACH). Res Involv Engagem. 2021 May 10;7(1):24. doi: 10.1186/s40900-021-00267-0.
PubMed 33971982van Helvoort EM, van Spil WE, Jansen MP, Welsing PMJ, Kloppenburg M, Loef M, Blanco FJ, Haugen IK, Berenbaum F, Bacardit J, Ladel CH, Loughlin J, Bay-Jensen AC, Mobasheri A, Larkin J, Boere J, Weinans HH, Lalande A, Marijnissen ACA, Lafeber FPJG. Cohort profile: The Applied Public-Private Research enabling OsteoArthritis Clinical Headway (IMI-APPROACH) study: a 2-year, European, cohort study to describe, validate and predict phenotypes of osteoarthritis using clinical, imaging and biochemical markers. BMJ Open. 2020 Jul 28;10(7):e035101. doi: 10.1136/bmjopen-2019-035101.
PubMed 32723735
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-year Multicentre, EU, Exploratory Study Without Therapeutic Benefit in Patients With Knee Osteoarthritis to Describe, Validate, and Predict Phenotypes of Knee Osteoarthritis by Use of Clinical, Imaging, and Biochemical (Bio)Markers.
- ClinicalTrials.gov ID
- NCT03883568
- Acronym / sponsor ID
- APPROACH / APPROACH-OA-P01
- Conditions
- Knee Osteoarthritis
- Keywords
- phenotypes, (bio)markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- F.P.J.G. LafeberUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Nordic Bioscience A/S, University of Surrey, Leiden University Medical Center, Complexo Hospitalario Universitario de A Coruña, Institut de Recherches Internationales Servier, Newcastle University, Merck KGaA, Darmstadt, Germany, Diakonhjemmet Hospital, Assistance Publique - Hôpitaux de Paris
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 3 Apr 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 21 Mar 2019 (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.
Rationale: Despite a large and growing disease burden in osteoarthritis (OA), many pharmaceutical companies have abandoned OA drug development. This is mainly due to the lack of appropriate outcome measures that can robustly identify patients that can benefit from a specific therapy. Different phenotypes of OA may benefit from different types of treatment. Therefore, novel markers to identify selected phenotypes of osteoarthritis may encourage drug development.
Objective: To prospectively describe in detail pre-identified progressing phenotypes of patients with knee OA by use of conventional and novel clinical, imaging, and biochemical (bio)markers, and to validate and refine a predictive model for these (and new) progressing phenotypes based on these markers.
Study design: APPROACH is an exploratory, European, five-centre, 2-year prospective follow-up, cohort study, with extensive measurements. In this study patients are treated according to regular care by their own physician with no study related treatment prescribed. Study related diagnostic and/or monitoring procedures are applied to the patients.
Study population: Patients with tibiofemoral knee osteoarthritis, according to the clinical ACR classification criteria, pre-identified based on demographic (e.g. age), clinical (e.g. Pain NRS) and tissue structure (e.g. radiographic joint space width) parameters.
Main study parameters/endpoints: Joint tissue structure based on radiographs, MRI, and biochemical (bio)markers as well as symptoms (pain, function) and quality of life by questionnaires.
Secondary parameters: A multitude of (novel and conventional) clinical, imaging, and biochemical parameters related to osteoarthritis.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participants will not have any direct benefit from their participation in this study other than that their OA is maximally diagnosed and followed in detail for up to 2 years (screening, baseline, 6 months, 12 months, 24 months).
Detailed description
Patients will stay in the hospital for 4-5 hours per visit (for screening about 30 min) for physical examination, blood draw, MRI scans, radiographs of knees and hands (only at baseline and 24 months), CT scan of the knee (only at baseline and 24 months), low radiation whole body CT scan (only at baseline and 24 months), HandScan (only at baseline and 24 months), motion analysis, and performance based tests. They will be asked to fill out questionnaires about knee, hand and hip osteoarthritis, and about general health and pain. The patient council in the consortium indicated that the load is acceptable. The patient council will be involved in the execution of the study. The assumed risk is minimal for an individual patient and minimal compared to the contribution to the development of knowledge of their disease. These risks include minimal events due to blood sampling itself (such as hematoma or localized bleeding), radiation exposure by radiographic imaging techniques (with a minimal increased healthcare risk), and exposure to MRI techniques (without known risks and without use of contrast agents).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tibiofemoral knee osteoarthritis, according to the clinical ACR classification criteria, pre-identified based on demographic (e.g. age), clinical (e.g. Pain NRS) and tissue structure (e.g. radiographic joint space width) parameters.
Key inclusion criteria (14 listed)
- Informed consent obtained.
- Ambulatory (able to walk unassisted)
- At least 18 years of age
- Capable of understanding the study
- Capable of writing and reading in local language
Key exclusion criteria (12 listed)
- Not being able to comply to the protocol
- Participating in a trial with local therapeutic intervention for index knee OA (pharmaceutical or surgical) or systemic Disease Modifying OsteoArthritic Drugs (DMOADs) or potential DMOADs treatments for OA at the same time or within the past 6 months or anticipated in the forthcoming; participation in non-interventional registries or epidemiological studies is allowed.
- Surgery of the index knee in the past 6 months (to avoid interferences with imaging)
- Scheduled or expected surgery of the index knee in the next 2 years (to avoid interferences with imaging)
- Pregnancy (child bearing woman) because of imaging (radiation and MRI, risks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OA structural progression of the index knee
Time frame: over two years
radiographic joint space width in mm
OA pain progression of the index knee
Time frame: over two years
increase in points in Knee Osteoarthritis Outcome Score for pain (0-100; 0 worst, 100 best condition)
2 secondary outcomes
OA progression of the index knee
Time frame: over two years
OA progression
Time frame: over two 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 1 Jun 2022.
- Derived from this study: PubMed 37179936Jansen MP, Wirth W, Bacardit J, van Helvoort EM, Marijnissen ACA, Kloppenburg M, Blanco FJ, Haugen IK, Berenbaum F, Ladel CH, Loef M, Lafeber FPJG, Welsing PM, Mastbergen SC, Roemer FW. Machine-learning predicted and actual 2-year structural progression in the IMI-APPROACH cohort. Quant Imaging Med Surg. 2023 May 1;13(5):3298-3306. doi: 10.21037/qims-22-949. Epub 2023 Mar 10.
- Derived from this study: PubMed 36710346Brett A, Bowes MA, Conaghan PG. Comparison of 3D quantitative osteoarthritis imaging biomarkers from paired CT and MR images: data from the IMI-APPROACH study. BMC Musculoskelet Disord. 2023 Jan 30;24(1):76. doi: 10.1186/s12891-023-06187-2.
- Derived from this study: PubMed 36397054Roemer FW, Jansen M, Marijnissen ACA, Guermazi A, Heiss R, Maschek S, Lalande A, Blanco FJ, Berenbaum F, van de Stadt LA, Kloppenburg M, Haugen IK, Ladel CH, Bacardit J, Wisser A, Eckstein F, Lafeber FPJG, Weinans HH, Wirth W. Structural tissue damage and 24-month progression of semi-quantitative MRI biomarkers of knee osteoarthritis in the IMI-APPROACH cohort. BMC Musculoskelet Disord. 2022 Nov 17;23(1):988. doi: 10.1186/s12891-022-05926-1.
- Derived from this study: PubMed 36336198Wirth W, Maschek S, Marijnissen ACA, Lalande A, Blanco FJ, Berenbaum F, van de Stadt LA, Kloppenburg M, Haugen IK, Ladel CH, Bacardit J, Wisser A, Eckstein F, Roemer FW, Lafeber FPJG, Weinans HH, Jansen M. Test-retest precision and longitudinal cartilage thickness loss in the IMI-APPROACH cohort. Osteoarthritis Cartilage. 2023 Feb;31(2):238-248. doi: 10.1016/j.joca.2022.10.015. Epub 2022 Nov 3.
- Derived from this study: PubMed 35575381van Helvoort EM, Jansen MP, Marijnissen ACA, Kloppenburg M, Blanco FJ, Haugen IK, Berenbaum F, Bay-Jensen AC, Ladel C, Lalande A, Larkin J, Loughlin J, Mobasheri A, Weinans HH, Widera P, Bacardit J, Welsing PMJ, Lafeber FPJG. Predicted and actual 2-year structural and pain progression in the IMI-APPROACH knee osteoarthritis cohort. Rheumatology (Oxford). 2022 Dec 23;62(1):147-157. doi: 10.1093/rheumatology/keac292.
- Derived from this study: PubMed 35246457Angelini F, Widera P, Mobasheri A, Blair J, Struglics A, Uebelhoer M, Henrotin Y, Marijnissen AC, Kloppenburg M, Blanco FJ, Haugen IK, Berenbaum F, Ladel C, Larkin J, Bay-Jensen AC, Bacardit J. Osteoarthritis endotype discovery via clustering of biochemical marker data. Ann Rheum Dis. 2022 May;81(5):666-675. doi: 10.1136/annrheumdis-2021-221763. Epub 2022 Mar 4.
- Derived from this study: PubMed 34911812van Helvoort EM, Welsing PMJ, Jansen MP, Gielis WP, Loef M, Kloppenburg M, Blanco F, Haugen IK, Berenbaum F, Bay-Jensen AC, Ladel C, Lalande A, Larkin J, Loughlin J, Mobasheri A, Weinans H, Lafeber F, Eijkelkamp N, Mastbergen S. Neuropathic pain in the IMI-APPROACH knee osteoarthritis cohort: prevalence and phenotyping. RMD Open. 2021 Dec;7(3):e002025. doi: 10.1136/rmdopen-2021-002025.
- Derived from this study: PubMed 33971982Taylor J, Dekker S, Jurg D, Skandsen J, Grossman M, Marijnissen AK, Ladel C, Mobasheri A, Larkin J, Weinans H, Kanter-Schlifke I; APPROACH research consortium and APPROACH Principal Investigators. Making the patient voice heard in a research consortium: experiences from an EU project (IMI-APPROACH). Res Involv Engagem. 2021 May 10;7(1):24. doi: 10.1186/s40900-021-00267-0.
- Derived from this study: PubMed 32723735van Helvoort EM, van Spil WE, Jansen MP, Welsing PMJ, Kloppenburg M, Loef M, Blanco FJ, Haugen IK, Berenbaum F, Bacardit J, Ladel CH, Loughlin J, Bay-Jensen AC, Mobasheri A, Larkin J, Boere J, Weinans HH, Lalande A, Marijnissen ACA, Lafeber FPJG. Cohort profile: The Applied Public-Private Research enabling OsteoArthritis Clinical Headway (IMI-APPROACH) study: a 2-year, European, cohort study to describe, validate and predict phenotypes of osteoarthritis using clinical, imaging and biochemical markers. BMJ Open. 2020 Jul 28;10(7):e035101. doi: 10.1136/bmjopen-2019-035101.
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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.
Floris PJ Lafeber, PhD study director
UMC Utrecht
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by F.P.J.G. Lafeber at 5 sites in 4 countries.
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 14 inclusion and 12 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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, France, Norway, Spain. 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?
OA structural progression of the index knee (time frame: over two years). The study lists 2 primary outcomes in all. 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 NCT03883568, which also lists 9 linked publications.
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 1 Jun 2022.