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Knee Osteoarthritis: Platelet Rich Plasma or Hyaluronic Acid (OA)

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ClinicalTrials.gov Identifier: NCT03801564
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
Tubitak
Information provided by (Responsible Party):
Naciye Fusun Toraman, Antalya Training and Research Hospital

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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Platelet Rich Plasma Treatment Group (PRP) Device: Hyaluronic Acid Treatment Group (HA) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Efficacy of Intra-articular Injections of Hyaluronic Acid and Platelet-rich Plasma for Patients With Knee Osteoarthritis: Changes in Function, Quality of Life and Cartilage Loss as Assessed by Magnetic Resonance Imaging
Estimated Study Start Date : January 7, 2019
Estimated Primary Completion Date : January 7, 2020
Estimated Study Completion Date : March 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Platelet Rich Plasma Group (PRP)
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)
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).

Experimental: Hyaluronic acid Group (HA)
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)
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.




Primary Outcome Measures :
  1. Change from Baseline Health Related Quality of Life Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Periodically During 12 Months [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Change from Baseline Pain measured by Visual Analogue Scale (VAS) Periodically During 12 Months [ Time Frame: 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. ]
    Activity and rest pain is evaluated on a straight line of fixed length, 100 mm (0 = no pain, 100 = the most severe pain). (Creamer et al., 1999)

  2. Change from Baseline Functional Strength Measured by Chair Stand Test Periodically During 12 Months [ Time Frame: 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. ]
    The patient stands up completely up from the sitting position, then completely backs down. The score is the total number of stands executed correctly within 30 seconds. The time in seconds is recorded using stop-watch (McAlindon et al., 2015).

  3. Change from Baseline Strength and Balance Measured by Stair Ascend/Descend Test Periodically During 12 months [ Time Frame: 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. ]
    The patient ascends and descends a flight of stairs (10-step stair) separately as soon as possible without handrail. The time in seconds is recorded using stop-watch (McAlindon et al., 2015).

  4. Change from Baseline Agility Measured by Timed Up-and-Go (TUG) Test Periodically During 12 months [ Time Frame: 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. ]
    The patient sitting in the chair, gets up, walks 3 meters without aid, walks back to the chair, then sits down. The score is the shortest time to rise from a chair, and return to the seated position. The time in seconds is recorded using stop-watch (McAlindon et al., 2015).

  5. Change from Baseline Endurance Measured by 6 Min Walk Test Periodically During 12 Months [ Time Frame: 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 ]
    The patient is asked to walk as fast and as possible in six minutes, between the two cones placed at a distance of 25 meters. The patient may be allowed to stop and then walk within the test period. Time of stop is recorded. The time in seconds is recorded using stop-watch (McAlindon et al., 2015).

  6. Change from Baseline Absolute Strength of Knee Extensor and Flexor Muscle by Isokinetic Test Periodically During 12 Months [ Time Frame: 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. ]
    Test measures absolute muscle strength of the quadriceps and hamstring muscles and is applied in concentric modality in speed of 60 degrees per second (5 repetitions) and 180 degrees per second (10 repetitions) in knee flexion and extension at 10-90 degrees of range of movement with gravity correction for both of the extremities. Absolute peak torque is recorded as Newtonmeter (Nm).

  7. Change from Baseline Relative Strength of Knee Extensor and Flexor Muscle by Isokinetic Test Periodically During 12 Months [ Time Frame: 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. ]
    Test measures relative strength of the quadriceps and hamstring muscles and is applied in concentric modality in speed of 60 degrees per second (5 repetitions) and 180 degrees per second (10 repetitions) in knee flexion and extension at 10-90 degrees of range of movement with gravity correction for both of the extremities. Relative peak torque is recorded as peak torque-to body weight ratio (Nm/kg)

  8. Change from Baseline Average Power of Knee Extensor and Flexor Muscle by Isokinetic Test Periodically During 12 months [ Time Frame: 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. ]
    Test measures average power of the quadriceps and hamstring muscles and is applied in concentric modality in speed of 60 degrees per second (5 repetitions) and 180 degrees per second (10 repetitions) in knee flexion and extension at 10-90 degrees of range of movement with gravity correction for both of the extremities. Muscular average power is recorded as Watt (W).

  9. Change from Baseline Health Status Measured by Nottingham Health Profile (NHP) Periodically During 12 Months [ Time Frame: The scale 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. ]
    NHP is a scale developed to measure perceived health. Turkish version of the scale used consists of two parts (Kucukdeveci et al, 2000). Part I contains 38 yes/no items that assess 6 subscales (pain, physical mobility, emotional reactions, energy, social isolation and sleep). The each question answered by yes is assigned a weighted value. Scores for each subscale can range from 0 to 100. Total score range of NHP is between 0-600. Part II contains 7 general yes/no questions concerning daily living problems and score range is between 0-7, with a higher score indicating greater distress for Part I and II.

  10. Change from Baseline Whole Organ MRI Scoring Periodically During 12 Months [ Time Frame: 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. ]
    Magnetic Resonance Images are scored with respect to 14 independent features of patellofemoral joint (PFJ),medial femorotibial joint(MFTJ), lateral femorotibial joint (LFTJ), and non-articulating portion of the tibial plateau (S). Total cartilage score range is between 0-84; total marrow abnormality and bone cysts range are between 0-45; total bone attrition range is between 0-42; total osteophyte range is between 0-98; total compartment range is 0-35 for MFTJ, LFTJ, and 0-28 for PFJ; total menisci score range is between 0-12,ligaments score range is between 0-12, synovitis score range is between 0-3. Subscales are summed for the total WORMS score whic is between 0-332 and the higher values represent a worse outcome.Additionally tendon abnormalities, avascular necrosis,stress fracture,insufficiency fracture,osteochondral fracture,tumors, and technical limitations that interfered with the reliability of the scoring are specified and noted. (Peterfy et al, 2004).

  11. Change from Patient Satisfaction Related with Treatment Periodically During 12 Months [ Time Frame: Patient satisfaction 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. ]
    The patient's global satisfaction related with the treatment is evaluated with a 6-point scale showing that the patient extremely satisfied from the treatment (1 point) and the patient extremely dissatisfied from the treatment (6 point) (Hoeksma et al, 2006).

  12. Change from Baseline Body Weight (BW) Periodically During 12 Months [ Time Frame: BW 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. ]
    BW is evaluated using TANITA MC-180MA and is recorded as kg.

  13. Change from Baseline % Fat Periodically During 12 Months [ Time Frame: % fat 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. ]
    % fat is evaluated using TANITA MC-180MA and is recorded as percentile value.

  14. Change from Baseline Body Mass Index (BMI) Periodically During 12 Months [ Time Frame: BMI 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. ]
    BMI is evaluated using TANITA MC-180MA and is recorded kg/square meter.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Presence of genu varum / valgum >50.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801564


Contacts
Contact: NFusun Toraman, Prof +902422494400 ext 3411 fusuntoraman@gmail.com

Sponsors and Collaborators
Antalya Training and Research Hospital
Tubitak
Investigators
Principal Investigator: NFusun Toraman, Prof Ministry of Health Antalya Training and Research Hospital
Study Chair: 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

Publications:
Responsible Party: Naciye Fusun Toraman, Professor, Antalya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03801564     History of Changes
Other Study ID Numbers: 118S014
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Naciye Fusun Toraman, Antalya Training and Research Hospital:
Knee Osteoarthritis
Hyaluronic Acid
Platelet Rich Plasma

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents