Knee Osteoarthritis Treatment With Percutaneous Injections of Autologous Bone Marrow Concentrate

NCT04310852 | Unknown DMC

• 1 other identifier: 528
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Knee Osteoarthritis; Cartilage Degeneration

Keywords

arthritis; knee; bone marrow concentrate

Outcome Measures

Primary Outcomes (1)

• Improvement of subjective International Knee Documentation Committee (IKDC)

  The IKDC subjective knee Form consists of questions, divided into four sections: Symptoms, Functionality during daily activities and sports, Current knee function, Participation in work and sports. The patient will fill the subjective IKDC questionnaire.

  up to 24 months

Secondary Outcomes (5)

• improvement according to the subscale Knee injury and Osteoarthritis Outcome Score (KOOS) pain

  up to 24 months

• improvement of the overall KOOS

  up to 24 months

• improvement of the TEGNER score

  up to 24 months

• Improvement according to Whole-Organ Magnetic Resonance Imaging Score (WORMS) MRI score

  up to 24 months

• Improvement according to Kellgren-Lawrence (K/L) score

  up to 24 months

Interventions

BioCue Concentration Kit DEVICE

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.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

25 patients, meeting specific inclusion and exclusion criteria, will be enrolled. In general, the patients are characterized as patients with painful arthritis of the medial or lateral compartment, which have not achieved a reduction in pain in the presence of conservative treatments. The patients are enrolled on the basis of a paper questionnaire based on the inclusion and exclusion criteria: a patient can only be enrolled if he or she responds positively to all questions related to the inclusion criteria and negatively to all questions related to the exclusion criteria.

You may qualify if:

• Male or female patients aged between 40 and 70;
• Medial or lateral arthrosis (grade 2-3 according to Kellgren-Lawrence score);
• Failure after at least 6 months of conservative treatment (patients not responding to drug therapy with NSAIDs and painkillers, no benefit from rehabilitation cycle in water or gym, no benefit after hyaluronic acid or platelet-rich plasma (PRP) infiltrations, or after at least one infiltration of corticosteroids);
• Ability and consent of patients to participate actively in the rehabilitation and clinical and radiological follow-up protocol;
• Signing of informed consent.

You may not qualify if:

• Patients who are incapable of understanding and will;
• Trauma patients within 6 months prior to surgery;
• Patients with malignancies;
• Patients with rheumatic diseases;
• Patients with diabetes;
• Patients with metabolic thyroid disorders;
• Patients abusing alcoholic beverages, drugs or drugs;
• Patients with lower limb impairment above 10°
• Body Mass Index \<18 or \> 35;
• Patients undergoing knee surgery during the 12 months prior to surgery;
• Patients with pathology ascribable to patellofemoral pathology;
• Untreated knee instability.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The portion of bone marrow concentrate of each patient not used for treatment will be sent to the biotechnology laboratory applied to the Orthopedics of the Institute Galeazzi and used for histological and molecular analysis. In particular, each sample will be characterized in terms of vitality, proliferation, cellular senescence, immunophenotype and differentiative capacity towards the osteogenic and chondrogenic lines. In addition, for each sample, the immunomodulatory activity exerted by the paracrine way in the presence of human chondrocytes stimulated by inflammatory conditions will be evaluated

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Elizaveta Kon, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizaveta Kon, MD

CONTACT

+390282247523; elizaveta.kon@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 17, 2020
• Study Start: June 6, 2018
• Primary Completion: September 30, 2021
• Study Completion: January 31, 2022
• Last Updated: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)