Clinical trial: Knee Osteoarthritis Treatment With Percutaneous Injections of Autologous Bone Marrow Concentrate (NCT04310852)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female patients aged between 40 and 70;

          2. Medial or lateral arthrosis (grade 2-3 according to Kellgren-Lawrence score);

          3. 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);

          4. Ability and consent of patients to participate actively in the rehabilitation and
             clinical and radiological follow-up protocol;

          5. Signing of informed consent.

        Exclusion Criteria:

          1. Patients who are incapable of understanding and will;

          2. Trauma patients within 6 months prior to surgery;

          3. Patients with malignancies;

          4. Patients with rheumatic diseases;

          5. Patients with diabetes;

          6. Patients with metabolic thyroid disorders;

          7. Patients abusing alcoholic beverages, drugs or drugs;

          8. Patients with lower limb impairment above 10°

          9. Body Mass Index <18 or > 35;

         10. Patients undergoing knee surgery during the 12 months prior to surgery;

         11. Patients with pathology ascribable to patellofemoral pathology;

         12. Untreated knee instability.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment