Comparing Efficacy of PRP Combined With Different Hyaluronan for the Treatment of Knee Osteoarthritis

NCT04931719 | Completed Phase 2 DMC

• 1 other identifier: VGHKS109-128
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Either PRP or HA is each effective for treating knee OA. However, the efficacy of combined PRP and HA injections remains unknown clinically.

Conditions

Knee Osteoarthritis

Keywords

Hyaluronic acid; Knee; Osteoarthritis; Platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• visual analog scale (VAS) pain change

  the change from baseline in the visual analog scale (VAS) pain score at 6 months. The patient rated the average severity of knee pain on knee movement over the previous week on a 0-100 mm VAS (0 = no pain to 100 = worst possible pain)

  Month 6

Secondary Outcomes (5)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale), t

  Month 6

• the Lequesne index

  Month 6

• single-leg stance test (SLS)

  Month 6

• patient satisfaction.

  Month 6

• consumption of analgesics

  Month 6

Study Arms (2)

the PRP+Artz group

ACTIVE COMPARATOR

The patients in the PRP+Artz group received one intraarticular Artz injection (2.5 ml) followed consecutively by one intraarticular injection of PRP (3ml).

Combination Product: PRP+Artz group; Combination Product: PRP+ HYAJOINT Plus group

the PRP+HYAJOINT Plus group

EXPERIMENTAL

The patients in the PRP+HYAJOINT Plus group received one intraarticular HYAJOINT Plus injection (3ml) followed by one intraarticular injection of PRP (3ml).

Combination Product: PRP+Artz group; Combination Product: PRP+ HYAJOINT Plus group

Interventions

PRP+Artz group COMBINATION_PRODUCT

The patients in the PRP+Artz group received one intraarticular Artz injection (2.5 ml) followed consecutively by one intraarticular injection of PRP (3ml).

the PRP+Artz group; the PRP+HYAJOINT Plus group

PRP+ HYAJOINT Plus group COMBINATION_PRODUCT

The patients in the PRP+HYAJOINT Plus group received one intraarticular HYAJOINT Plus injection (3ml) followed by one intraarticular injection of PRP (3ml).

the PRP+Artz group; the PRP+HYAJOINT Plus group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 20-85 years Symptomatic knee osteoarthritis for more than 6 months despite analgesics, NSAIDs, or physical therapy Kellgren-Lawrence grade-2 knee osteoarthritis seen on radiographs made within previous 6 months Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.

You may not qualify if:

• Previous orthopedic surgery on spine or lower limb Disabling osteoarthritis of either hip or foot Knee instability, apparent joint effusion, or marked valgus/varus deformity Known allergy to avian proteins or hyaluronan products Confirmed or suspected pregnancy, or lactating Intra-articular injections into knee in previous 6 months Any specific medical conditions (rheumatoid arthritis, active infection, hemiparesis, neoplasm, hematological etc.) that would interfere with assessments

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (16)

• Sun SF, Lin GC, Hsu CW, Lin HS, Liou IS, Wu SY. Comparing efficacy of intraarticular single crosslinked Hyaluronan (HYAJOINT Plus) and platelet-rich plasma (PRP) versus PRP alone for treating knee osteoarthritis. Sci Rep. 2021 Jan 8;11(1):140. doi: 10.1038/s41598-020-80333-x.

  PMID: 33420185 RESULT

• Sanchez M, Anitua E, Delgado D, Sanchez P, Prado R, Orive G, Padilla S. Platelet-rich plasma, a source of autologous growth factors and biomimetic scaffold for peripheral nerve regeneration. Expert Opin Biol Ther. 2017 Feb;17(2):197-212. doi: 10.1080/14712598.2017.1259409. Epub 2016 Nov 28.

  PMID: 27845852 RESULT

• Laudy AB, Bakker EW, Rekers M, Moen MH. Efficacy of platelet-rich plasma injections in osteoarthritis of the knee: a systematic review and meta-analysis. Br J Sports Med. 2015 May;49(10):657-72. doi: 10.1136/bjsports-2014-094036. Epub 2014 Nov 21.

  PMID: 25416198 RESULT

• Jain NK, Gulati M. Platelet-rich plasma: a healing virtuoso. Blood Res. 2016 Mar;51(1):3-5. doi: 10.5045/br.2016.51.1.3. Epub 2016 Mar 25. No abstract available.

  PMID: 27104183 RESULT

• Mlynarek RA, Kuhn AW, Bedi A. Platelet-Rich Plasma (PRP) in Orthopedic Sports Medicine. Am J Orthop (Belle Mead NJ). 2016 Jul-Aug;45(5):290-326.

  PMID: 27552452 RESULT

• Webb D, Naidoo P. Viscosupplementation for knee osteoarthritis: a focus on Hylan G-F 20. Orthop Res Rev. 2018 Oct 23;10:73-81. doi: 10.2147/ORR.S174649. eCollection 2018.

  PMID: 30774462 RESULT

• Sun SF, Hsu CW, Lin HS, Liou IH, Chen YH, Hung CL. Comparison of Single Intra-Articular Injection of Novel Hyaluronan (HYA-JOINT Plus) with Synvisc-One for Knee Osteoarthritis: A Randomized, Controlled, Double-Blind Trial of Efficacy and Safety. J Bone Joint Surg Am. 2017 Mar 15;99(6):462-471. doi: 10.2106/JBJS.16.00469.

  PMID: 28291178 RESULT

• Russo F, D'Este M, Vadala G, Cattani C, Papalia R, Alini M, Denaro V. Platelet Rich Plasma and Hyaluronic Acid Blend for the Treatment of Osteoarthritis: Rheological and Biological Evaluation. PLoS One. 2016 Jun 16;11(6):e0157048. doi: 10.1371/journal.pone.0157048. eCollection 2016.

  PMID: 27310019 RESULT

• Weibrich G, Hansen T, Kleis W, Buch R, Hitzler WE. Effect of platelet concentration in platelet-rich plasma on peri-implant bone regeneration. Bone. 2004 Apr;34(4):665-71. doi: 10.1016/j.bone.2003.12.010.

  PMID: 15050897 RESULT

• McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Rheum. 2001 Oct;45(5):453-61. doi: 10.1002/1529-0131(200110)45:53.0.co;2-w. No abstract available.

  PMID: 11642645 RESULT

• Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

  PMID: 3068365 RESULT

• Lequesne MG, Mery C, Samson M, Gerard P. Indexes of severity for osteoarthritis of the hip and knee. Validation--value in comparison with other assessment tests. Scand J Rheumatol Suppl. 1987;65:85-9. doi: 10.3109/03009748709102182.

  PMID: 3479839 RESULT

• Srinivasan PP, McCoy SY, Jha AK, Yang W, Jia X, Farach-Carson MC, Kirn-Safran CB. Injectable perlecan domain 1-hyaluronan microgels potentiate the cartilage repair effect of BMP2 in a murine model of early osteoarthritis. Biomed Mater. 2012 Apr;7(2):024109. doi: 10.1088/1748-6041/7/2/024109. Epub 2012 Mar 29.

  PMID: 22455987 RESULT

• Abate M, Verna S, Schiavone C, Di Gregorio P, Salini V. Efficacy and safety profile of a compound composed of platelet-rich plasma and hyaluronic acid in the treatment for knee osteoarthritis (preliminary results). Eur J Orthop Surg Traumatol. 2015 Dec;25(8):1321-6. doi: 10.1007/s00590-015-1693-3. Epub 2015 Sep 24.

  PMID: 26403468 RESULT

• Zhao J, Huang H, Liang G, Zeng LF, Yang W, Liu J. Effects and safety of the combination of platelet-rich plasma (PRP) and hyaluronic acid (HA) in the treatment of knee osteoarthritis: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2020 Apr 11;21(1):224. doi: 10.1186/s12891-020-03262-w.

  PMID: 32278352 RESULT

• Huang HY, Hsu CW, Lin GC, Lin HS, Chou YJ, Liou IH, Sun SF. Comparing efficacy of a single intraarticular injection of platelet-rich plasma (PRP) combined with different hyaluronans for knee osteoarthritis: a randomized-controlled clinical trial. BMC Musculoskelet Disord. 2022 Nov 4;23(1):954. doi: 10.1186/s12891-022-05906-5.

  PMID: 36329428 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Shu-Fen Sun

  Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: One of the investigator, blinded to the allocation groups, performed all the assessments. The patients were blinded, by preventing visual access to the injection field with a screen placed between them and their knee during the injection process. They were not informed of which HA they had received during the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Neurorehabilitation Director

Model Details: The purpose of this study was to compare the efficacy of a single Artz injection followed by PRP with a single HYAJOINT Plus injection followed by PRP in the management of knee OA.

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 18, 2021
• Study Start: July 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)