Clinical trial NCT05076526: PRP-HA Versus HA in Knee Osteoarthritis
Official title: Randomized Controlled Trial Comparing Cellular Matrix Combination of Platelet Rich Plasma With Hyaluronic Acid (CM-PRP-HA) Versus Hyaluronic Acid in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Osteoarthritis, Knee
Keywords: Platelet-rich plasma
Hyaluronic acid
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 132
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blinded randomised controlled trial.
Primary purpose: TREATMENT

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.

Detailed description: In vitro experimentations have also established the efficacy of PRP, where chondrocytes stimulated with PRP has shown to increase proteoglycan and collagen synthesis which bears similar biochemical qualities to that of hyaline cartilage. PRP has also shown to provide more critical growth factors (including PDGF, TGF-beta, IGF, EGF, VEGF, FGF) than conventional culture media, increasing the synthesis of major cellular proteins and collagen in the extracellular component of intervertebral disc cells, potentially enhancing the functional properties of joint cartilages.

Presently, cellular matrix (CM) remains as the only device which allows for the combination of PRP and HA to be delivered to patients within a single intra-articular injection. However, there are insufficient large-scale studies to reliably evaluate the efficacy of PRP-HA on knee OA and formulate a universal recommendation on its treatment regimen. There are also no RCTs conducted on our local population to explore the effects of CM-PRP-HA on knee OA.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
timeFrame: Baseline
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline at 1 month
timeFrame: 1 month after last injection
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline at 3 months
timeFrame: 3 months after last injection
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline at 6 months
timeFrame: 6 months after last injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: