The Comparison of Knee Osteoarthritis Treatment With Bone Marrow Aspirate Concentrate , Leukocyte Rich Platelet Rich Plasma and Hyaluronic Acid

NCT03825133 | Completed Phase 4

• 1 other identifier: CCVBMACKnee
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  after 1, 3, 6, 9 and 12 months

Secondary Outcomes (5)

• change of SF-36

  after 1, 3, 6, 9 and 12 months

• Change of IKDC

  after 1, 3, 6, 9 and 12 months

• change of VAS pain

  after 3, 7 14 and 21 days

• VAS pain injection

  up to 10 minutes after after intervention

• VAS score after injection of fluid

  up to 10 minutes after after intervention

Other Outcomes (1)

• Knee injection portals influence on final clinical results.

  after one year

Study Arms (3)

Bone Marrow Aspirate Concentrate

EXPERIMENTAL

Patients treated with single injection of BMAC in the knee

Procedure: Bone Marrow Aspirate Concentrate

Leukocyte Rich Platelet Rich Plasma

EXPERIMENTAL

Patients treated with single injection of LR-PRP in the knee

Procedure: Leukocyte Rich Platelet Rich Plasma

Hyaluronic Acid

EXPERIMENTAL

Patients treated with 3 single injection of high molecular HA in the knee ( one injection weekly)

Drug: Hyaluronic Acid

Interventions

Bone Marrow Aspirate Concentrate PROCEDURE

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

Bone Marrow Aspirate Concentrate

Leukocyte Rich Platelet Rich Plasma PROCEDURE

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

Leukocyte Rich Platelet Rich Plasma

Hyaluronic Acid DRUG

Three injections of Cartinorm (1% Sodium Hyaluronat (20mg/2 ml) by Goodwill Pharma) is injected in the knee weekly

Also known as: HA

Hyaluronic Acid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• history of complaints of knee pain because of the Knee Osteoarthritis with no relief using anti-inflammatory agents even after 3 months,
• Kellgren-Lawrence (KL) grade 2-4
• normal blood results and coagulation profile (platelets 150,000-450,000/l),
• patients who had not undergone any surgery on the affected knee within 2 years prior to the first injection and
• Mentally fit for clinical study

You may not qualify if:

• severe knee instability,
• severe misalignment,
• unicompartmental OA
• BMI more than 35
• inflammatory arthritis such as rheumatoid arthritis and ankylosing spondylitis
• presenting muscle pain underlying diseases such as hematologic disorders, septicemia, coagulopathy, neoplasm, active infection, and immune deficiency

Sponsors & Collaborators

• Clinical Center of Vojvodina: lead

Study Sites (1)

Clinical Center of Vojvodina

Novi Sad, Vojvodina, 21137, Serbia

Location

Related Publications (11)

• Chahla J, Alland JA, Verma NN. Bone Marrow Aspirate Concentrate for Orthopaedic Use. Orthop Nurs. 2018 Nov/Dec;37(6):379-381. doi: 10.1097/NOR.0000000000000502.

  PMID: 30451775 BACKGROUND

• Chahla J, Mandelbaum BR. Biological Treatment for Osteoarthritis of the Knee: Moving from Bench to Bedside-Current Practical Concepts. Arthroscopy. 2018 May;34(5):1719-1729. doi: 10.1016/j.arthro.2018.01.048. Epub 2018 Apr 5.

  PMID: 29628381 BACKGROUND

• Jones IA, Togashi R, Wilson ML, Heckmann N, Vangsness CT Jr. Intra-articular treatment options for knee osteoarthritis. Nat Rev Rheumatol. 2019 Feb;15(2):77-90. doi: 10.1038/s41584-018-0123-4.

  PMID: 30498258 BACKGROUND

• Chahla J, Dean CS, Moatshe G, Pascual-Garrido C, Serra Cruz R, LaPrade RF. Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee: A Systematic Review of Outcomes. Orthop J Sports Med. 2016 Jan 13;4(1):2325967115625481. doi: 10.1177/2325967115625481. eCollection 2016 Jan.

  PMID: 26798765 BACKGROUND

• Chu CR, Rodeo S, Bhutani N, Goodrich LR, Huard J, Irrgang J, LaPrade RF, Lattermann C, Lu Y, Mandelbaum B, Mao J, McIntyre L, Mishra A, Muschler GF, Piuzzi NS, Potter H, Spindler K, Tokish JM, Tuan R, Zaslav K, Maloney W. Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference. J Am Acad Orthop Surg. 2019 Jan 15;27(2):e50-e63. doi: 10.5435/JAAOS-D-18-00305.

  PMID: 30300216 BACKGROUND

• Filardo G, Di Matteo B, Kon E, Dhillon MS, Patel S, Marwaha N. Platelet-rich plasma for knee osteoarthritis. Am J Sports Med. 2013 Sep;41(9):NP42-3. doi: 10.1177/0363546513502635. No abstract available.

  PMID: 23997229 BACKGROUND

• Evans CH, Kraus VB, Setton LA. Progress in intra-articular therapy. Nat Rev Rheumatol. 2014 Jan;10(1):11-22. doi: 10.1038/nrrheum.2013.159. Epub 2013 Nov 5.

  PMID: 24189839 BACKGROUND

• Garratt AM, Brealey S, Gillespie WJ; DAMASK Trial Team. Patient-assessed health instruments for the knee: a structured review. Rheumatology (Oxford). 2004 Nov;43(11):1414-23. doi: 10.1093/rheumatology/keh362. Epub 2004 Aug 17.

  PMID: 15316121 BACKGROUND

• Dulic O, Abazovic D, Matijevic S, Rasovic P, Obradovic M, Bjelobrk M, Tosic M, Lalic I, Baljak B, Milinkov M. Quality of life changes in patients suffering from knee osteoarthritis treated with bone marrow aspirate concentrate, platelet-rich plasma and hyaluronic acid injections. Regen Med. 2025 Feb-Mar;20(2-3):87-96. doi: 10.1080/17460751.2025.2472589. Epub 2025 Mar 3.

  PMID: 40028743 DERIVED

• Rasovic P, Dulic O, Lalic I, Matijevic R, Janjic N, Tosic M, Aleksandric D, Abazovic D, Miskulin M, Matijevic S, Kovacevic L. The role of osteoarthritis severity, BMI and age on clinical efficacy of bone marrow aspirate concentrate in the treatment of knee osteoarthritis. Regen Med. 2023 Sep;18(9):735-747. doi: 10.2217/rme-2023-0042. Epub 2023 Aug 14.

  PMID: 37577967 DERIVED

• Dulic O, Lalic I, Kecojevic V, Gavrilovic G, Abazovic D, Miskulin M, Maric D, Bumbasirevic M. Do knee injection portals affect clinical results of bone marrow aspirate concentrate injection in the treatment of osteoarthritis? A prospective randomized controlled study. Regen Med. 2020 Aug;15(8):1987-2000. doi: 10.2217/rme-2020-0020. Epub 2020 Nov 5.

  PMID: 33151802 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oliver Dulic MD, M.sci . Orthopaedic Surgeon, Principal Investigator

Model Details: Patients will be randomly assigned to 3 groups: LR-PRP group, the BMAC group or HA group. Functional scores and outcomes will be compared to determine clinical efficacy of all groups and which treatment is more effective in treating knee OA

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 31, 2019
• Study Start: April 1, 2016
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: February 7, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: after data analyze

Locations

SE (1)