A Phase 4 interventional study of Bone Marrow Aspirate Concentrate and Leukocyte Rich Platelet Rich Plasma in Knee Osteoarthritis, sponsored by Clinical Center of Vojvodina. Completed at 1 site in Serbia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-02-07.
Sponsored by Clinical Center of Vojvodina · Phase 4, Interventional, and Treatment
The aim of this study is to compare therapeutic and clinical effects of intra-articular injection of Bone Marrow Aspirate Concentrate (BMAC), inta-articular injection of Leukocyte Rich Platelet Rich plasma (LR-PRP) and 3 weekly doses of high molecular weight of Hyaluronic acid for the treatment of osteoarthritis (OA) of the knee ( KL scale II-IV).
Osteoarthritis (OA) is the most common joint disease worldwide, affecting an estimated 10% of men and 18% of women over 60 years of age with the knee and hip joints predominantly involved. The pain and loss of function can be debilitating; in developed countries the resultant socioeconomic burden is large costing between 1, 0% and 2, 5% of gross domestic product. Several therapeutic options for the treatment of OA are widely used, consists of pain management, physical therapy with life-modifying recommendations, joint injections with joint replacement for end-stage disease. Intra-articular drug delivery has several advantages over systemic delivery, including increased local bioavailability, reduced systemic exposure, fewer adverse events and reduced cost. Three injectable materials have been widely used for intra-articular treatment of the knee OA: corticosteroids (with or without local anesthetics), hyaluronic acid based preparations and in the last decade biologic preparations, such as human serum albumin, TNF and Il-1 inhibitors, platelet-rich plasma (PRP) injections, bone marrow-derived stem cells (BMSCs), adipose-derived stem cells (ADSCs) and amnion-derived mesenchymal stem cells (AMSCs) etc PRP is promising therapeutic option for the OA treatment, there are still many concerns with PRP's efficiency. Among all questions, ( Number of platelets, percentage in accordance with baseline, frequency of doses etc.) presence or absence of different cells in PRP formulations ( as leukocytes), could significantly change an overall clinical result. In general, PRP could be Leukocyte-rich (LR- with increase number of Leukocytes in comparison with baseline number) and Leukocyte-poor.
Another option that has become more popular for physicians treating this debilitation condition is BMAC, which use undifferentiated cells found in the bone marrow to promote healing and tissue regeneration. These cells have the ability to replicate into a multiple different tissue types. With BMAC, the marrow is concentrated provide better healing of the damaged tissue and aid in growth and repair. The full benefits of BMAC are still unknown, but studies have shown the treatment can reduce swelling, relieve pain, and improve healing in articular cartilage and bone grafts.
Autologous BMAC has shown promising clinical potential as a therapeutic agent in regenerative medicine, including the treatment of osteoarthritis and cartilage defects, and the clinical efficacy platelet rich plasma has been documented to alleviate symptoms related to knee osteoarthritis. However, randomized, prospective comparison of the two techniques has not been reported in the literature and long term follow-up for both treatments is limited, and especially limited in the use of BMAC for the knee OA treatment.
From the other hand, HA preparations are widely used in everyday practice for almost 30 years with variable results. No one of these therapeutic options are not yet recommended by supreme professional organizations ( e.g.AAOS) because of paulacity of scientific data and unbiased confirmation of their clinical efficiency with a broad advice for necessity of more rigorous clinical trials.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 180 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
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Exclusion Criteria:
Patients treated with single injection of BMAC in the knee
Procedure: Bone Marrow Aspirate Concentrate
Patients treated with single injection of LR-PRP in the knee
Procedure: Leukocyte Rich Platelet Rich Plasma
Patients treated with 3 single injection of high molecular HA in the knee ( one injection weekly)
Drug: Hyaluronic Acid
Bone marrow ( 100 ml) is aspirated from proximal tibia, concentrated in Arthrex Angel Centrifuge, and after concentration 6 ml of BMAC is injected in the knee
Also known as: BMAC
Blood sample is taken ( 100 ml), centrifuged in Arthrex Angel Centrifuge and after double spinning process about 6 ml of PRP is injected in the knee
Also known as: LR-PRP
Three injections of Cartinorm (1% Sodium Hyaluronat (20mg/2 ml) by Goodwill Pharma) is injected in the knee weekly
Also known as: HA
change of WOMAC
Purpose of WOMAC scale is to assess the course of disease or response to treatment in patients with knee or hip osteoarthritis (OA).Content: Three subscales, 24 items.: 1) pain severity during various positions or movements, 2) severity of joint stiffness, and 3) difficulty performing daily functional activities.Response options/scale: In the Likert version, each item offers 5 responses: "none" scored as 0, "mild" as 1,"moderate" as 2, "severe" as 3, and "extreme" as 4. Alternatively, the VAS and numerical rating scale versions permit responses to be selected on a 100-mm or 11-box horizontal scale, respectively, with the left end marked as "none" and the right end marked as "extreme". The range for possible subscale scores in the Likert format are: pain (0-20; 5 items each scored 0-4), stiffness (2 items, 0-8), and physical function (17 items, 0-68). Score interpretation: Higher scores indicate worse pain, stiffness, or physical function.
Time frame: after 1, 3, 6, 9 and 12 months
Change of KOOS
Purpose of KOOS is To measure patients' opinions about their knee and associated problems over short- and long-term follow- up Intended populations/conditions: young and middle-aged people with posttraumatic osteoarthritis (OA), as well as those with injuries that may lead to post traumatic OA (e.g., ACL, meniscal, osteochondral injury) Content. Five domains: 1) pain frequency and severity during functional activities; 2) symptoms such as the severity of knee stiffness and the presence of swelling, grinding or clicking, catching, and range of motion restriction; 3) difficulty experienced during activities of daily living; 4) difficulty experienced with sport and recreational activities; and 5) knee-related quality of life.Number of items: 42 items across 5 subscales. Score interpretation: 0- extreme problems and 100- no problems.
Time frame: after 1, 3, 6, 9 and 12 months
change of SF-36
The SF-36 is multi-item generic health surveys intended to measure "general health concepts not specific to any age, disease, or treatment group" . The original objective was to develop a short, generic health-status measure that reproduces the 2 summary scores of the SF-36, i.e., the physical component summary (PCS) score and the mental component summary (MCS) score (2). The SF-36 consists of 36 items, 35 of which are used in the calculation of 8 separate scale scores. The physical functioning scale (10 items) is the longest scale. Scores on the SF-36 and SF-12 scales range from 0-100, with higher scores indicating better health. On the physical functioning scale, low scores are typical of someone who experiences many limitations in physical activities, including bathing or dressing, while high scores represent someone who is able to perform these types of activities without limitations
Time frame: after 1, 3, 6, 9 and 12 months
Change of IKDC
Purpose of IKDC is to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment Intended populations/conditions: Patients with a variety of knee conditions, including ligament injuries, meniscal injuries, articular cartilage lesions, and patellofemoral pain. Content: Three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury (not included in the total score). Number of items.18 (7 items for symptoms, 1 item for sport participation, 9 items for daily activities, and 1 item for current knee function). Possible score range 0-100, where 100 means no limitation with daily or sporting activities and the absence of symptoms.
Time frame: after 1, 3, 6, 9 and 12 months
change of VAS pain
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases .The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. Instructions, time period for reporting, and verbal descriptor anchors have varied widely in the literature depending on intended use of the scale.The pain VAS is a single-item scale. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]) (6-8). To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not recommended .A higher score indicates greater pain intensity.
Time frame: after 3, 7 14 and 21 days
VAS pain injection
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases .The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. Instructions, time period for reporting, and verbal descriptor anchors have varied widely in the literature depending on intended use of the scale.The pain VAS is a single-item scale. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]) (6-8). To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not recommended .A higher score indicates greater pain intensity.
Time frame: up to 10 minutes after after intervention
VAS score after injection of fluid
The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, including those with rheumatic diseases .The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. Instructions, time period for reporting, and verbal descriptor anchors have varied widely in the literature depending on intended use of the scale.The pain VAS is a single-item scale. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]) (6-8). To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not recommended .A higher score indicates greater pain intensity.
Time frame: up to 10 minutes after after intervention
Knee injection portals influence on final clinical results.
We used three most widely used portals: (1) The anterolateral portal (AL) where patient is supine, with a knee in full extension where a needle is placed 1 cm above the joint line and just next to the patellar tendon in a palpable soft spot with the knee passively fully flexed to a tolerable degree for the patient ranging from 100 to 130, with a foot internally rotated. (2) The anteromedial portal (AM) is placed 1 cm above the joint line and 1 cm medial to the patellar tendon, also in a palpable soft and (3) Superolateral portal ( SL) involved insertion of a needle 1 cm above and 1 cm lateral to the superior lateral aspect to the patella at a 45 degrees angle. Then, patients were asked to describe pain during injection procedure alone using Visual Analog Scale After 12 months, we calculate, are there any statistical differences in previous scales ( WOMAC, KOOS, IKDC, SF-26) in accordance with a portal placement.
Time frame: after one year
Plan to share: Yes — de-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting information: Statistical analysis plan, Informed consent form, Clinical study report
Time frame: after data analyze
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Studies of the drug tested here: Hyaluronic Acid
Clinical Center of Vojvodina