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Knee Osteoarthritis Treatment With Percutaneous Injections of Autologous Bone Marrow Concentrate

NCT04310852 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2020-03-17

No results posted yet for this study

Summary

Recently there has been a growing interest in the role of subchondral bone in knee arthritis, both in its etiology and evolution and in its clinical significance. It has now been widely demonstrated that changes in the subchondral bone can develop both as a cause and as a consequence of joint degeneration and it is now accepted in the scientific community that the presence of these changes is of clinical importance, causing pain and an inflammatory state that can contribute to the evolution of arthrosis arthropathy. Recently the use of mesenchymal cells obtained from the bone marrow has been proposed for the treatment of gonarthrosis by intra-articular injections. Even more recently, treatments have been studied and proposed for the treatment of the bone-cartilage interface in knees affected by osteoarthrosis, using autologous bone marrow concentrate, with promising results.

Conditions

Interventions

DEVICE

BioCue Concentration Kit

The treatment will be carried out in the operating room under ordinary hospitalization and involves the application of 9 ml of autologous bone marrow concentrate in the knee affected by arthrosis. Specifically, 3 ml will be applied at the level of the bone-cartilage interface of the femur, 3 ml at the level of the bone-cartilage interface of the tibia, and 3 ml will be injected into the joint for a simultaneous action also at the level of the cartilage. To obtain the necessary amount of bone marrow concentrate, an aspirate of bone marrow will be taken from the iliac crest (60 ml) and homolateral tibia (30 ml) of the patient and concentrated by BioCue Concentration Kit, company Zimmer biomet, and centrifuge. This autologous bone marrow concentrate will be injected by means of the Perfuse at the level of the tibial and femoral bone-cartilage interface of the percutaneous arthrosis affected compartment under radiographic control.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • Elizaveta Kon, MD · Istituto Clinico Humanitas

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-06
Primary Completion
2021-09-30
Completion
2022-01-31

Countries

  • Italy

Study Locations

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Entities

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 NCT04310852 on ClinicalTrials.gov