Clinical trial: Subchondroplasty® Knee RCT (NCT03112200)

Eligibility criteria:
Inclusion Criteria:

          -  Candidates must meet ALL of the following:

               1. Voluntary signature of the Institutional Review Board/Research Ethics Board
                  approved Informed Consent,

               2. Male or female subjects between the ages of 30 to 75 years,

               3. Body Mass Index ≤ 40 (BMI=kg/m2),

               4. Has experienced pain in study knee for at least 3 months,

               5. Kellgren-Lawrence grade 1-3 Osteoarthritis, as reviewed on preoperative XR
                  imaging, in the study knee,

               6. BML is confirmed on T2 weighted or Proton Density MR Imaging by presence of white
                  signal,

               7. Single BML of tibia, single BML of femur, or adjoining BML's of tibia & femur, in
                  the same compartment, extending to the articular surface of the joint,

               8. Surgical candidate for knee arthroscopy due to mechanical symptoms, meniscus
                  tear, loose body and/or synovitis,

               9. Must record a response, at the preoperative study visit, of moderate to extreme
                  pain for any one of the KOOS Pain Scale questions, P2 through P9,

              10. Index knee alignment is defined radiographically as one of the following:
                  Neutral, ≤ 6° mechanical varus, or ≤ 6° mechanical valgus,

              11. Ligaments in the study knee are stable,

              12. The contralateral (non-study) knee is stable and functional,

              13. Is refractory to conservative non-surgical management

                    1. having failed 2 or more of the following: hyaluronic acid injection,
                       corticosteroid injection, NSAIDs, physical therapy, bracing, activity
                       modification, or minimal surgical intervention (e.g., arthroscopy,
                       debridement/chondroplasty, and/or loose body removal)

                    2. and is ≥ 3 months from the start of treatment,

              14. Must be physically and mentally willing and able, in the Investigator's opinion
                  at the time of enrollment, to be compliant with the protocol - including all
                  follow-up visits, survey completion, weight-bearing restrictions, and
                  post-operative rehabilitation.

        Exclusion Criteria:

          -  Candidates will be excluded if they meet ANY of the following:

               1. BML caused by acute trauma less than 3 months prior to enrollment,

               2. Clinical and/or radiographic disease diagnosis of the index knee that includes
                  any of the following:

                    1. Kellgren-Lawrence Grade 4 Osteoarthritis with complete loss of joint space
                       (bone-on-bone) or subchondral bone collapse,

                    2. Rheumatoid arthritis, or history of septic or reactive arthritis,

                    3. Gout or a history of gout or pseudogout in the affected knee,

                    4. Has more than two clinically relevant BMLs in the index knee,

                    5. Osteochondritis dissecans of the knee with significant bone loss,

                    6. Collapse of subchondral bone,

                    7. Clinically relevant BML located at ACL/PCL insertion,

                    8. MRI evidence of frank ligament instability,

               3. Passive knee flexion < 110° or flexion contracture >30°,

               4. History of systemic diseases which could contribute to secondary arthropathies
                  (e.g., sickle cell disease, hemochromatosis, or autoimmune disease),

               5. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the
                  ability to perform objective functional assessment of either knee,

               6. If diabetic, blood glucose over 200 mg/dL at time of enrollment,

               7. Current daily tobacco or high nicotine product user or < 3 months from nicotine
                  cessation,

               8. Presents a high surgical risk due to unstable cardiac and/or pulmonary disease,

               9. Has HIV or other immunodeficient state including subjects on immunosuppressant
                  therapies, or has significant illness (metastasis of any type) that decreases the
                  probability of survival to the 2 year endpoint,

              10. Is at substantial risk for the need of organ transplantation, such as renal
                  insufficiency,

              11. Is pregnant or breast-feeding at the time of surgery,

              12. Has a history of any invasive malignancy (except non-melanoma skin cancer),
                  unless treated with curative intent and with no clinical signs or symptoms of the
                  malignancy for 5 years,

              13. Has primary bone tumor in the knee area,

              14. Anticipates having a lower extremity surgery other than the investigational
                  surgery during the course of the study,

              15. Is participating concurrently in another clinical trial, or has participated in a
                  clinical trial within 30 days of surgery,

              16. Is receiving prescription pain medication other than NSAIDs or acetaminophen for
                  conditions unrelated to the index knee condition, chronic use of anticoagulants,
                  or taking corticosteroids,

              17. Active joint infection or history of chronic joint infection at the surgical
                  site,

              18. Prior total meniscectomy of index knee,

              19. Has primarily patellofemoral symptoms,

              20. Is indicated for concomitant procedures (i.e., microfracture, subchondral
                  drilling, cartilage allograft, ligament or tendon repair, distal
                  realignment/osteotomy, root repair) in the index knee, with the exception of
                  incidental loose body removal, debridement, synovectomy, osteophyte removal in
                  locations other than adjacent to BMLs, and/or partial meniscectomy,

              21. Has contraindications for Magnetic Resonance Imaging (MRI),

              22. Is receiving worker's compensation or is currently involved in litigation
                  relating to the index knee,

              23. Has a history of substance abuse.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 75 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? Contradiction