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PRP-HA Versus HA in Knee Osteoarthritis

NCT05076526 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2021-10-13

No results posted yet for this study

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

Interventions

BIOLOGICAL

Hyaluronic acid (Synolis VA)

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

BIOLOGICAL

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

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%)

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-11-30
Completion
2022-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05076526 on ClinicalTrials.gov