PRP-HA Versus HA in Knee Osteoarthritis

NCT05076526 | Unknown Phase 2 DMC

• 1 other identifier: In progress
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief Summary

Osteoarthritis (OA) is a prevalent chronic condition which most commonly affects the knee. The pathogenesis of OA involves initial mechanical stress resulting in cartilage lesions, leading to inflammatory processes causing joint degradation. Numerous pharmacological and non-pharmacological therapies have been employed, including hyaluronic acid (HA) supplementations to alleviate the joint damage from mechanical load by acting as a shock absorber which provides lubrication, and intra-articular corticosteroid injections to reduce inflammation. However, HA is unable to facilitate cartilage regeneration and corticosteroids has numerous undesirable side effects which render them unsustainable treatment options. Recently, many studies worldwide have demonstrated that platelet-rich-plasma (PRP) stimulates cartilage repair by actively secreting growth factors which activate cell proliferation and differentiation thereby promoting tissue regeneration. However, there has been varying results across various RCTs due to the heterogeneity of studies, with inconclusive recommendations on the treatment regimen for PRP-HA. Currently, PRP treatment is also not formally recognized as a treatment modality for knee OA in many countries, including Singapore. This randomised controlled trial aims to compare the efficacy of Cellular Matrix (CM) PRP-HA versus HA (Synolis VA) intra-articular injections in knee OA through quantifying the improvement in long-term treatment outcomes such as pain, stiffness, and functional impairment, potentially improving the quality of life for many patients with knee OA.

Conditions

Osteoarthritis, Knee

Keywords

Platelet-rich plasma; Hyaluronic acid

Outcome Measures

Primary Outcomes (4)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

  WOMAC score comprises pain score, stiffness score and functional impairment score. Pain scores range from 0 to 20, stiffness scores range from 0 to 8, functional impairment scores range from 0 to 68. Total WOMAC score, which is an addition of the above 3 components, range from 0 to 96. Higher scores indicate worse outcomes

  Baseline

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline at 1 month

  WOMAC score comprises pain score, stiffness score and functional impairment score. Pain scores range from 0 to 20, stiffness scores range from 0 to 8, functional impairment scores range from 0 to 68. Total WOMAC score, which is an addition of the above 3 components, range from 0 to 96. Higher scores indicate worse outcomes

  1 month after last injection

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline at 3 months

  WOMAC score comprises pain score, stiffness score and functional impairment score. Pain scores range from 0 to 20, stiffness scores range from 0 to 8, functional impairment scores range from 0 to 68. Total WOMAC score, which is an addition of the above 3 components, range from 0 to 96. Higher scores indicate worse outcomes

  3 months after last injection

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline at 6 months

  WOMAC score comprises pain score, stiffness score and functional impairment score. Pain scores range from 0 to 20, stiffness scores range from 0 to 8, functional impairment scores range from 0 to 68. Total WOMAC score, which is an addition of the above 3 components, range from 0 to 96. Higher scores indicate worse outcomes

  6 months after last injection

Study Arms (2)

HA

ACTIVE COMPARATOR

Patients will receive 2 intra-articular injections of 2mL Synolis VA (20 mg/mL HA and 40 mg/mL sorbitol), with an interval of 1 month between both injections.

Biological: Hyaluronic acid (Synolis VA)

PRP-HA

EXPERIMENTAL

Patients will receive 2 intra-articular injections of 5mL CM-PRP-HA combination (3mL of autologous PRP, 2mL of 16mg/mL HA), with an interval of 1 month between both injections.

Biological: Cellular Matrix platelet-rich-plasma with hyaluronic acid (CM PRP-HA)

Interventions

Hyaluronic acid (Synolis VA) BIOLOGICAL

Synolis VA harbours the following characteristics: * NaHA (Sodium hyaluronate): 20mg/mL, biofermantative and pharmaceutical grade origin. * Sorbitol: 40mg/mL * Molecular weight of 2MDa, sterilized in moist heat

HA

Cellular Matrix platelet-rich-plasma with hyaluronic acid (CM PRP-HA) BIOLOGICAL

The CM-PRP-HA tube is under vacuum containing the following: * 2mL of hyaluronic acid gel in phosphate buffer (Sodium chloride, Dipotassium hydrogenphosphate, Potassium dihydrogenphosphate, Potassium chloride and water for injection). Not crosslinked Hyaluronic Acid (40mg per tube) is obtained from fermentation * 3g of inert cell-selector gel * 0.6mL of anticoagulant (sodium citrate 4%)

PRP-HA

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of age 30 years and above
• Radiographical diagnosis of knee OA - ie narrowing of joint space, presence of osteophytes, possible sclerosis and subchondral cysts
• History of chronic pain in knee or knee swelling for at least 3 months
• Ability of patients to provide informed consent

You may not qualify if:

• Concurrent complementary and alternative medicine (CAM) treatments e.g. acupuncture
• Inflammatory diseases / infection / fracture / trauma
• Malignancies
• Pregnant or lactating females
• Consistent use of NSAIDs within 48 hours of procedure
• Corticosteroid injection at treatment site within 1 month
• Systemic use of corticosteroids within 2 weeks
• Tobacco use
• (For patients receiving PRP-HA injection only): Hemoglobin \<10 g/dL and platelets \<150,000/mm3

Sponsors & Collaborators

• Singapore General Hospital: lead

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

Central Study Contacts

Kenon Chua, MBBS, MRCSEd, FRCSEd

CONTACT

+65 6222 3322; kenonchua@icloud.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgery Registrar

Model Details: This is a single-blinded randomised controlled trial.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: October 13, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share