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Completed

NCT Number: NCT02070224

Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis

The purposes of this study are to assess the prognostic value of serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline, and their change over the first year, on the progression of knee osteoarthritis MRI scores at 12 months, on the progression of knee osteoarthritis clinical score at 12 months. Additionally, this study will search for correlations between serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline with the radiographic, MRI and clinical severity of knee osteoarthritis.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Liege-CHU, Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, aged 45 to 80 years with a BMI ≤ 40
  • With an uni- or bilateral femorotibial knee osteoarthritis associated or not with a femoro-patellar knee osteoarthritis
  • Responding to clinical and radiological criteria of the ACR
  • Symptomatic for more than 6 months (for the most painful knee)
  • K&L radiological grade of Felson II or III
  • With a cartilage lesion identified during MRI and either at least 1 out of 4 MRI severity criteria:
  • bone oedema
  • meniscal lesion in the central region of the medial compartment
  • effusion without answer to corticosteroids
  • zone without cartilage
  • or at least 1 out of 3 clinical severity criteria:
  • genu varum>3°
  • previous meniscal surgery
  • known polyarthritis
  • effusion on the target knee
  • Sign an informed consent after being informed
  • Able to follow the instructions of the study
  • With an agreement from the physicians having established the diagnosis of osteoarthritis (if any) to give relevant information to the investigator
  • With health insurance (for France).

Exclusion criteria

For osteoarthritis:

  • Isolated patellofemoral arthritis
  • Chondromatosis or villo-nodular synovioma of the knee
  • Recent trauma-induced knee pain
  • Joint disease due to joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, …
  • inflammatory pathologies as rheumatoid polyarthritis, gout arthritis, infectious arthritis
  • Diseases that may interfere with the evaluation of osteoarthritis (radiculalgia of lower limbs, arteritis, …)
  • Genu valgum (degree considered as pathological by the physician)

For previous treatments:

  • Treatment with strontium ranelate, bisphosphonates, SERM and PTH

For known associated diseases:

  • Serious associated diseases: severe liver or renal failure, uncontrolled cardiovascular disease, HIV, hepatitis B or C
  • Knee tumor

For patients:

  • Patient who participated to a therapeutic clinical trial 3 months before the T0 inclusion visit
  • Patient who are the subject of a judicial protection measure or under guardianship
  • Pregnant woman

For MRI contraindications:

  • Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
  • Patient with a ferromagnetic splinter in the body, or having wire sutures
  • Serious mobility problem (Parkinson, tremors)

Treatment and study plan

Serum and urine samples collections

Other

Serum and urine samples will be collected at baseline, 3 month, 6 month, 12 month to assess the predictive value of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 on OA progression (MRI, Clinical and radiological progression)

Imaging (x-rays and MRI)

Other

MRI will be done at baseline and 12 month and x-rays will be done at baseline

Primary outcomes

  1. MRI will be analysed with semiquantitative Whole-Organ Magnetic Resonance Imaging Scoring method (WORMS)

    Time frame: 12 month

Secondary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS) and Visual Analogue Scales (VAS) for mean knee pain and global patient assessment of disease activity

    Time frame: 12 month

Other outcomes

  1. Knee prosthesis during the study

    Time frame: 12 month

  2. MRI cartilage volume (optional)

    Time frame: 12 month

  3. MRI T2 relaxation time (optional)

    Time frame: 12 month

  4. MRI MOAKS scoring (optional)

    Time frame: 12 month

Sponsors and collaborators

Lead sponsor

Artialis

Industry

Registry information

Acronym: PRODIGE

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Feb 25, 2014
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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