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OsteoarthritisIBBM-CKJNCT02555514

Identification of Biochemical and Biomechanical Markers for Cartilage Degeneration in the Knee Joint (IBBM-CKJ)

An observational study of Osteoarthritis, run by Dr. Jan Siewe.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The association between varus malalignment and dynamic knee loading / adduction moment and progression of knee joint cartilage degeneration in the lateral compartment is unclear and has not been studied in detail before. There is a need to identify relevant parameters explaining this cause-effect relationship. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis
How many people
100 participants
Where
No sites listed yet
Study dates
Oct 2015to Dec 2017
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: End stage medial, bi- or tricompartimental OA with indication to total knee replacement with failure of conservative treatment

Who may be able to join

  • End stage medial, bi- or tricompartimental OA with indication to total knee replacement with failure of conservative treatment
  • No more than mild symptoms of other joints in the lower limbs (VAS≤ 4)
  • Age > 18 years
  • BMI < 35
  • Written informed consent must be obtained from all patients prior to any study-related procedure.

Who cannot join

  • BMI ≥ 35
  • Post-infectious condition of the affected knee
  • Valgus- or neutral lower limb axis
  • Pacemaker or any other medical condition that does not allow MRI scans
  • Systemic arthritic conditions
  • Previous surgery of lower extremities and/or low back within the last 6 months
Show all 10Show fewer
  • Musculoskeletal or neurological condition severely affecting lower limb function
  • Contraindications to MRI
  • Not able to walk independently without a walking aid
  • Additional infection

Trial locations and contacts

No sites are listed yet.

Johannes Oppermannn, Dr. med. contact

+49-221-478-87294

johannes.oppermann@uk-koeln.de

Jens Dargel, Dr.med. contact

+49-221-478-87294

jens.dargel@uk-koeln.de

About this study

The association between varus malalignment and dynamic knee loading / adduction moment and progression of knee joint cartilage degeneration in the lateral compartment is unclear and has not been studied in detail before. There is a need to identify relevant parameters explaining this cause-effect relationship. It is the purpose of the study to correlate load changes in knee joints with biomechanical and biochemical alterations in cartilage to understand the underlying mechanism of load induced cartilage degeneration in patients. This study will therefore include patients with different stages of knee OA with various malalignments. Moreover, analyzing changes in cartilage morphology, radiography and MRI and correlate those findings with alterations in biochemical parameters in cartilage, serum, urine and synovial fluid will allow us to identify novel biomarkers for the onset and progression of joint cartilage degeneration in varus malaligned knees.

The following hypotheses will be tested:

  1. Knee joint cartilage degeneration progresses from medial to lateral in varus-aligned knees.
  2. External knee adduction moments in patients with isolated medial OA are higher when compared with patients with OA of the medial and lateral compartment.
  3. Morphological and mechanical properties of cartilage show different stages of degeneration when comparing the mechanically stronger loaded medial with the lateral compartment of the knee.
  4. Histological and biochemical analysis of the cartilage indicate different stages of degeneration when comparing the mechanically loaded medial with the lesser loaded lateral compartment of the knee.
  5. Synovial fluid analysis, as well as serum biomarkers of cartilage metabolism demonstrate cartilage degeneration and are related to biomechanical determinants of OA in the knee.
  6. Novel biomarkers (ECM, miRNA, cytokines, mitochondria related, mechanical determinants) for varus-aligned knees can be identified.
Read the detailed description

Osteoarthritis (OA) is a painful and debilitating disease of the synovial joints, affecting the structural and functional integrity of articular cartilage, subchondral bone, synovium and the adjacent supporting connective tissue . It is a degenerative disorder characterized by cartilage loss with high prevalence in individuals over an age of 55 years. The most affected region in OA is the medial compartment of the knee. The symptoms of OA include joint pain, stiffness, and swelling which may lead to impaired physical function and muscle weakness . The etiology of the disease is multifactorial and not fully understood. Traditionally, OA was regarded as a "wear and tear" disease caused by ageing, but both non-physiological mechanical loading (e.g. malalignment, obesity, trauma or joint instability) of a normal joint or physiological mechanical loading of a pathological joint can induce OA .

Joint misalignment has been identified as a potential biomechanical risk factor for development and progression of knee OA. Although determination of malalignment might provide important information about the load distribution in static conditions , dynamic loading parameters have been analyzed during gait to provide information about the total extrinsic load at the knee during the stance phase. According to Andriacchi, the external knee adduction moment can be used to predict load distribution between the medial and lateral compartments of the knee during dynamic activities. Increased external adduction moments are associated with increased joint forces on the medial plateau. During walking, forces are not evenly distributed across the joint surface and approximately 70% of the total load passes through the medial compartment. This may contribute to the higher prevalence of OA in this compartment . It can be expected that in patients with a varus deformity an even higher proportion of load is supported by the medial compartment. This may result in acceleration of articular cartilage degeneration.

The link between mechanical loading and the severity and progression of medial OA has been shown by many studies. Disease severity was found to correlate with the knee adduction moment , knee adduction angular impulse and knee extension moment . Miyazaki et al. analyzed the disease progression of OA patients during seven years. Patients that showed radiographic disease progression in the medial knee compartment also presented more severe knee pain and greater knee adduction moment than patients without disease progression. Baliunas et al. observed a significant greater knee adduction moment in OA patients with different levels of disease severity, but no significant differences were found in the sagittal moments. Thorp et al. analyzed not only the knee adduction moment but also the knee adduction angular impulse for the stance phase in healthy subjects and OA patients with mild and moderate disease progression in the medial knee compartment. The peak knee adduction moment and the knee adduction angular impulse were significant different between the control group, mild and moderate OA patients. Furthermore, the parameter knee adduction angular impulse was significantly different between mild and moderate OA patients, suggesting that this parameter can describe functional changes between different stages of disease progression.

While the relationship of varus malalignment and OA of the medial compartment is well described in the literature, little information is available if and how varus malalignment affects the lateral compartment. Fantini Pagani recently demonstrated that cartilage mechanical quality is not related to the knee adduction moment during gait in patients with severe OA.

Authors further reported that mechanical properties of osteoarthritic cartilage are highly variable indicating a complex relationship between joint loading and tissue changes during degenerative processes of articular cartilage. In clinical practice, patients with an identical mechanical varus malalignement of the lower extremity may show either isolated osteoarthritis of the medial compartment of the knee (example 1), or OA of the medial, lateral and patellofemoral compartment (example 2). This entity suggests that osteoarthritic disease in varus malaligned knees, in which the medial compartment is submitted to excessive overload, progress from medial to lateral over time. It could be assumed that mechanobiological factors and inflammatory reactions rather than mechanical load transmission play a major role in disease progression in the osteoarthritic knee.

Mechanobiological factors are thought to cause changes in articular cartilage thickness distributions in a joint throughout life . Healthy articular cartilage tends to be thickest in joints that experience high forces such as the knee. In addition, side differences in muscle cross sectional area positively correlated with side differences in articular cartilage morphology . Previous studies showed, that for healthy knees, the ratio of medial to lateral cartilage is greater in individuals that have a larger peak knee adduction moment during walking, suggesting that cartilage is thicker in areas where load is greater. These results are supported by those from animal studies in which articular cartilage increased in thickness by up to 19 to 23% when high mechanical loads were applied. An increase in cartilage thickness with exposure to higher loads may be off-set by a greater cartilage surface that may be caused by high physical activity during growth . Changes in tibio-femoral cartilage thickness are not dose-dependent suggesting that adult human cartilage morphology may not be sensitive to or improve with training .

Previous studies on animals and humans have shown that disuse like immobilization or strenuous mechanical loading induces changes in cartilage morphology and biology.

Cartilage composition and morphology is optimized for load-bearing function and characterized by the ability to sustain high and repetitive mechanical loads occurring during daily living. This mechanical function of cartilage is directly linked to the composition of the extracellular matrix (ECM). The synthesis and degradation of ECM molecules affect the mechanical properties of articular cartilage. The main ECM components are collagen II and non-collagenous proteins such as the proteoglycan aggrecan and other glycoproteins. Potential biological markers for cartilage metabolism include these matrix components and/or their breakdown products, cytokines, and proteases (eg. metalloproteases) and they can be quantified in serum, urine and synovial samples. Several serum biomarkers have been identified to monitor cartilage metabolism . One established biomarker for monitoring cartilage metabolism in relation to joint degeneration in OA , rheumatoid arthritis (RA) and injured knees is cartilage oligomeric matrix protein (COMP). In addition, previous studies have reported an increase in serum COMP concentration immediately after exercise with the dose of mechanical loads determining the magnitude and duration of increased serum COMP concentration. Besides COMP, biomarker of collagen II and aggrecan synthesis and degradation are suitable to monitor cartilage metabolism. Moreover, microRNAs can play a pivotal role for extracellular matrix homeostasis and are detectable at specific stages during OA progression. So far, miR-140, miR-9, miR-98 and miR-146 were found to be upregulated in osteoarthritic patient material and their expression is linked to the IL-1 beta induced production of TNF-alpha and matrix degradation in osteoarthritic cartilage . miRNAs can be released to the serum in various diseases and may have prognostic potential to determine the onset and progression of cartilage degeneration during OA. Finally, mitochondria damage is linked to reduced ECM production, secretion and enhanced degradation in cartilage. Recent reports show that specific inhibitors of the mitochondrial respiratory chain can suppress the synthesis of the ECM in articular chondrocytes and induced the production of proinflammatory cytokines and multiple factors released from damaged mitochondria, e.g damage mitochondrial DNA, reactive oxygen species, cytochrome c, proline/hydroxyproline synthesis, ATP and lactate production, could act as biomarkers for OA.

Inflammation within the joint of the knee is important in the pathophysiologic processes occurring after the onset of OA by high mechanical load. Cytokines are key players in the inflammatory mechanism and contribute to the progression of the cartilage damage. Therefore, the investigators focus on the effects of inflammation in OA and the role of pro-inflammatory and anti-inflammatory cytokines which can cause a deleterious or beneficial outcome. Investigation of the underlying mechanisms will help the investigators in understanding how cytokines contribute to the progression of OA and provide potential targets for novel therapeutics and biomarkers for diagnosis and prognosis of OA. Differences in the cytokine profile were reported for patients with OA, RA and healthy controls. Specific cytokines which are involved in OA were previously detected in blood as well as in synovial fluid . Cytokine expression in fluids may represent reliable diagnostic marker for early and late stages of OA. Recent data indicate potential correlations in the cytokine profile between blood and synovial fluid , which should be validated in the investigations. In addition, the investigators want to analyze the cytokine profile in tissue samples of OA and correlate the results with the profiles of serum and synovial fluid and clinical parameters. These results could link inflammatory reactions induced by the OA of the medial compartment to malalignment and to a progression of OA in the unaffected areas of the lateral compartments.

In summary, greater knee adduction moment is associated with greater load transmission through the medial knee compartment. Numerous studies identified increased knee adduction moment in patients with medial knee OA and varus deformity compared to healthy subjects. However, it is unclear how varus malalignment and dynamic knee loading / adduction moment affects the cartilage of lateral compartment. Morphological and biochemical markers are able to analyse cartilage degeneration in vivo in humans in relation to mechanical loading, a potential biomechanical risk factor for development and progression of knee OA.

Conditions
Osteoarthritis
Medical subject headings
Osteoarthritis

What participants receive

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

Study groups in NCT02555514
Study groupRoleWhat they receive
Knee OsteoarthritisThe study population consists of 100 enrolled patients with different stages of knee OA and varus malalignment >4° with respect to the mechanical loading axis of the lower extremity. A minimum of 40 patients are to be included per year, so that the study period will be planned from January 1st, 2015 to June 30th, 2017. Preliminary results will be reviewed by the end of every year and intermediate reports will be generated by the sub-study-groups

What is being measured

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

  1. measurement of Knee joint cartilage degeneration progresses from medial to lateral in varus-aligned knees in mm .

    The association between varus malalignment and dynamic knee loading / adduction moment and progression of knee joint cartilage degeneration in the lateral compartment is unclear and has not been studied in detail before. There is a need to identify relevant parameters explaining this cause-effect relationship. It is the purpose of the study to correlate load changes in knee joints with biomechanical and biochemical alterations in cartilage to understand the underlying mechanism of load induced cartilage degeneration in patients. This study will therefore include patients with different stages of knee OA with various malalignments. Moreover, analyzing changes in cartilage morphology, radiography and MRI and correlate those findings with alterations in biochemical parameters in cartilage, serum, urine and synovial fluid will allow us to identify novel biomarkers for the onset and progression of joint cartilage degeneration in varus malaligned knees.

    Measured: Change from Baseline 12 month

Timeline

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

  1. First posted21 Sep 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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 crossover
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02555514
Sponsor's protocol ID
IBBM-CKJ
Acronym
IBBM-CKJ
Status last verified
Sep 2015
First submitted
15 Sep 2015
Last updated
21 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis, run by Dr. Jan Siewe.

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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Johannes Oppermannn, Dr. med. (+49-221-478-87294, johannes.oppermann@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measurement of Knee joint cartilage degeneration progresses from medial to lateral in varus-aligned knees in mm . (time frame: Change from Baseline 12 month). 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 21 Sep 2015.

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