Knee Osteoarthritis: Platelet Rich Plasma or Hyaluronic Acid

NCT03801564 | Unknown

• 1 other identifier: 118S014
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE: To compare the effect of hyaluronic acid (HA) or platelet-rich plasma (PRP) on pain, physical function, quality of life and knee joint morphology in patients with knee osteoarthritis severity II-III. BACKGROUND: Knee osteoarthritis affects quality of life significantly because it is the most common joint disease and causes considerable disability. Pathogenesis is multifactorial, nevertheless reduced cartilage production, increased destruction, and synovial inflammation are important factors in the osteoarthritis process. Today, symptomatic drugs are commonly used in the treatment of osteoarthritis, but these treatments have limited effects on cartilage degeneration. Intraarticularly, hyaluronic acid (HA) and platelet-rich plasma (PRP) treatments have been used for osteoarthritis due to pain and functional effects. HA has been shown to reduce the levels of collagen degradation products and maintain normal cartilage metabolism. PRP is thought to have positive effects on clinical and tissue healing due to the numerous growth factors involved. However there is no research to prove definitively that one of the two applications in knee osteoarthritis is superior to the other. METHOD: 120 patients between the ages of 50-70, OA severity II-III will be included in the study. Patients will be stratified according to the severity and age of OA, and two groups will be randomly assigned as HA and PRP. HA and PRP injections will be performed two times and one month apart. Outcome measures are pain, physical function, quality of life, muscle strength, WORMS, and patient satisfaction. Each patient will be examined at baseline, first, third, sixth, ninth and twelfth months.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Hyaluronic Acid; Platelet Rich Plasma

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Health Related Quality of Life Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Periodically During 12 Months

  The validated and reliable Turkish version of WOMAC consisted of three subscales- pain, stiffness, and physical function. Subscale of pain score range is between 0-20; stiffness score range is between 0-8; physical function score range is between 0-68. Values are summed up and the correction factors are used which are 0.50 for pain, 1.25 for stiffness, 0.147 for physical function to obtain total score. Total WOMAC score is between 0-100 and the higher scores indicate the greater disease severity.

  The scale is filled before the first and second injection which is one month apart, then the evaluation continues at 3rd, 6th, 9th, and 12th month.

Secondary Outcomes (14)

• Change from Baseline Pain measured by Visual Analogue Scale (VAS) Periodically During 12 Months

  VAS is evaluated before the first and second injection which is applied one month apart, then the evaluation continues at 3rd, 6th, 9th, and 12th month.

• Change from Baseline Functional Strength Measured by Chair Stand Test Periodically During 12 Months

  The test is evaluated before the first and second injection which is applied one month apart, then the evaluation continues at 3rd, 6th, 9th, and 12th month.

• Change from Baseline Strength and Balance Measured by Stair Ascend/Descend Test Periodically During 12 months

  The test is evaluated before the first and second injection which is applied one month apart, then the evaluation continues at 3rd, 6th, 9th, and 12th month.

• Change from Baseline Agility Measured by Timed Up-and-Go (TUG) Test Periodically During 12 months

  The test is evaluated before the first and second injection which is applied one month apart, then the evaluation continues at 3rd, 6th, 9th, and 12th month.

• Change from Baseline Endurance Measured by 6 Min Walk Test Periodically During 12 Months

  The test is evaluated before the first and second injection which is applied one month apart, then the evaluation continues at 3rd, 6th, 9th, and 12th month

Study Arms (2)

Platelet Rich Plasma Group (PRP)

EXPERIMENTAL

Platelet Rich Plasma Treatment Group (PRP): The blood is drawn from the antecubital vein to the 10cc line of EasyPRP syringe consisted 1.5ml of anticoagulant. The syringe is centrifuged at a rate of 1200 g for 2 minutes. Then the syringe is rotated and the lower chamber filled with erythrocytes is discharged. The connector is inverted and the air gap is discharged. The injector is again centrifuged at 1200G for 10 minutes. Then the injector is rotated in the direction of the arrow, the lower stopper is removed. The application injector of 3cc with connector is placed in the EasyPRP injector. 1 ml of the PRP containing Buffycoat is separated for content analysis, the remaining 2 ml of the string is injected. Injection is repeated one month interval

Device: Platelet Rich Plasma Treatment Group (PRP)

Hyaluronic acid Group (HA)

EXPERIMENTAL

Hyaluronic Acid Treatment Group (HA): 2 ml HA (32mg / ml) containing 1.6% sodium hyaluronate is injected intraarticular. The molecular weight is 800 - 1200 K Dalton. The viscosity is 20 pascal / s. The pH of the product is 7-7.5.Injection is repeated one month interval.

Device: Hyaluronic Acid Treatment Group (HA)

Interventions

Platelet Rich Plasma Treatment Group (PRP) DEVICE

EASY PRP is in category IIa and manufactured by Neotec Biotechnology Industry and Foreign Trade Company. (Item No. 8680976403603; UNSPSC 42295470; GMDN 46923; certificate no: M.2016.106.7294).

Platelet Rich Plasma Group (PRP)

Hyaluronic Acid Treatment Group (HA) DEVICE

REGENFLEX STARTER is a class III intraarticular viscosupplementation device (Art. No. 8681065100076; UNSPSC 42295509). Sodium hyaluronate is obtained by bacterial fermentation (STREPTOCOCCUS EQUI) method. The product is in disposable packages, sterile and contained in a 2 ml pyrogen-free syringe.

Hyaluronic acid Group (HA)

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 50-70 years of age
• Kellgren Lawrence (KL) radiological grade II-III knee OA
• Sedanter
• Unilateral knee pain
• Volunteer

You may not qualify if:

• KL radiological grade ≥2 of contrlateral knee
• Thrombocytopenia (\<150.000/mm3)
• Coagulopathy
• Osteoarthritis of multiple joints
• Acute exacerbation of any joint
• Intraarticular steroid, PRP or HA injection within 6 months
• Non-steroidal anti inflammatory drugs or steroid use within 6 weeks
• Diabetes and cancer
• Severe anemia (hemoglobin \<10)
• Presence of heart and lung disease that can not perform physical function tests
• Secondary inflammatory arthritis
• Knee surgery or knee injury
• Planning for joint replacement within the next 3 months
• Difficulty in answering the questionnaires
• Limitation in joint range of motion

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Naciye Fusun Toraman

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (6)

• Creamer P, Lethbridge-Cejku M, Hochberg MC. Determinants of pain severity in knee osteoarthritis: effect of demographic and psychosocial variables using 3 pain measures. J Rheumatol. 1999 Aug;26(8):1785-92.

  PMID: 10451078 BACKGROUND

• McAlindon TE, Driban JB, Henrotin Y, Hunter DJ, Jiang GL, Skou ST, Wang S, Schnitzer T. OARSI Clinical Trials Recommendations: Design, conduct, and reporting of clinical trials for knee osteoarthritis. Osteoarthritis Cartilage. 2015 May;23(5):747-60. doi: 10.1016/j.joca.2015.03.005.

  PMID: 25952346 BACKGROUND

• Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.

  PMID: 15639634 BACKGROUND

• Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.

  PMID: 10826123 BACKGROUND

• Peterfy CG, Guermazi A, Zaim S, Tirman PF, Miaux Y, White D, Kothari M, Lu Y, Fye K, Zhao S, Genant HK. Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee in osteoarthritis. Osteoarthritis Cartilage. 2004 Mar;12(3):177-90. doi: 10.1016/j.joca.2003.11.003.

  PMID: 14972335 BACKGROUND

• Hoeksma HL, van den Ende CH, Breedveld FC, Ronday HK, Dekker J. A comparison of the OARSI response criteria with patient's global assessment in patients with osteoarthritis of the hip treated with a non-pharmacological intervention. Osteoarthritis Cartilage. 2006 Jan;14(1):77-81. doi: 10.1016/j.joca.2005.07.019. Epub 2005 Oct 7.

  PMID: 16214379 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• NFusun Toraman, Prof

  Ministry of Health Antalya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Meral Bilgilisoy Filiz, MD,PM&R

  Ministry of Health Antalya Training and Research Hospital

  STUDY CHAIR

• Yasemin Karaman, MD,Radiology

  Ministry of Health Antalya Training and Research Hospital

  STUDY CHAIR

• Sevim Yildiz, MD,Radiology

  Ministry of Health Sancaktepe Training and Research Hospital

  STUDY CHAIR

• Asli Karadag Ozdemir, MD,Res.Ass.

  Health Sciences University Antalya Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There are five investigators in this study. N.Fusun Toraman is project manager and blind for the study groups. Yasemin Karaman and Sevim Yıldız are radiologists and blind for the study groups. Meral Bilgilisoy Filiz and Aslı Karadag Ozdemir know the groups, they will select the participants, and Meral Bilgilisoy Filiz will apply intraarticular injections via ultrasound. The participants of the groups do not know each other.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The volunteer, sedanter patients with Kellgren Lawrence (KL) radiological grade II-III knee OA, unilateral knee pain, aged 50-70 years will be selected. Exclusion criterias are; KL radiological grade ≥2 of contrlateral knee, thrombocytopenia, coagulopathy, OA of multiple joints, acute exacerbation of any joint, intraarticular steroid, PRP or HA injection within 6 months, non-steroidal anti inflammatory drugs or steroid use within 6 weeks; diabetes and cancer; severe anemia (Hb \<10), presence of heart and lung disease that can not perform physical function tests, secondary inflammatory arthritis; knee surgery or knee injury; planning for joint replacement within the next 3 months, difficulty in answering the questionnaires, limitation in joint range of motion, presence of genu varum/valgum \>50. Patients will be divided into two groups: Group 1: HA group, Group 2: PRP group, using covariate adaptive randomization as age and osteoarthritis severity covariate.

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 11, 2019
• Study Start: January 7, 2019
• Primary Completion: January 7, 2020
• Study Completion: March 7, 2020
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)