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

NCT02555514 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2015-09-21

No results posted yet for this study

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. 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.

Conditions

Sponsors & Collaborators

  • Dr. Jan Siewe

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-12-31
Completion
2017-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02555514 on ClinicalTrials.gov