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

Knee Osteoarthritis Clinical Trial

Official title:

Comparing Efficacy of Platelet-rich Plasma (PRP) Combined With Different Hyaluronan for the Treatment of Knee Osteoarthritis: a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04931719
• Other study ID #: VGHKS109-128
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2021
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Intraarticular plasma-rich platelet (PRP) or hyaluronic acid (HA) was each effective for knee osteoarthritis(OA). The efficacy of combined injections remains unknown. This study aimed to evaluate the efficacy of PRP combined with different hyaluronan for treating knee OA. In a prospective, randomized-controlled trial, 95 patients with Kellgren-Lawrence grade 2 knee OA were randomized to receive a single intraarticular Artz (10mg/ml) followed by PRP (N=48) into target knee or single HYAJOINT Plus (20mg/ml) injection followed by PRP (N=47). Primary outcome was the change from baseline in the visual analog scale (VAS) pain at 6 months. Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, single leg stance test (SLS), use of rescue analgesics and patient satisfaction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Combination Product:
• PRP+Artz group
The patients in the PRP+Artz group received one intraarticular Artz injection (2.5 ml) followed consecutively by one intraarticular injection of PRP (3ml).
• PRP+ HYAJOINT Plus group
The patients in the PRP+HYAJOINT Plus group received one intraarticular HYAJOINT Plus injection (3ml) followed by one intraarticular injection of PRP (3ml).

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

References & Publications (15)

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 — View Citation

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 — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Erratum in: Scand J Rheumatol 1988;17(3):following 241 — View Citation

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. — View Citation

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. Review. — View Citation

Russo F, D'Este M, Vadalà 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.pon — View Citation

Sánchez 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: 10.1080/1471 — View Citation

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):02410 — View Citation

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 Jo — View Citation

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: 10.103 — View Citation

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. Review. — View Citation

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. — View Citation

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 A — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert Scale), t	(WOMAC, Likert Scale) is a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and higher scores indicate worse outcomes.	Month 6
Secondary	the Lequesne index	Lequesne index was used to assess severity of knee symptoms during the last week. It includes the measurement of pain, walking distance, and activities of daily living. Maximal score is 24 and higher scores represent worse function.	Month 6
Secondary	single-leg stance test (SLS)	Single-leg stance test (SLS) is done by raising one foot up without touching it to the supported lower extremity with target knee and maintain balance for as long as possible. Each participant performed 3 trials, and the best result of the 3 trials was recorded.	Month 6
Secondary	patient satisfaction.	Patients were asked to rate their treatment satisfaction compared to the preinjection condition, using a 100 mm VAS (0= completely dissatisfied, 100=completely satisfied).	Month 6
Secondary	consumption of analgesics	Acetaminophen (500mg; maximum daily dose, 4 g) was the only rescue medication allowed for knee pain during the study period, Use of rescue medication during the study period was recorded in a patient diary.	Month 6