Clinical Efficacy of Platelet-Rich Plasma and Hyaluronic Acid Versus Hyaluronic Acid for Knee Osteoarthritis with MRI Analysis

Changi General Hospital

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis, Knee

Treatments

Device: Orthovisc

Device: Cellular Matrix

Study type

Interventional

Funder types

Other

Identifiers

NCT06636695

2020-2035

Details and patient eligibility

About

The study hypothesizes that the combination of Cellular Matrix PRP-HA is superior to Hyaluronic Acid (HA) alone, specifically from the Orthovisc Kit, in relieving pain and function associated with knee osteoarthritis.

The primary objective is to assess pain reduction following treatment. The secondary objectives, includes assessing the treatment's impact on function, stiffness, and overall quality of life for patients. In addition, non-invasive MRI will be employed at baseline and 12 months to evaluate changes in bone marrow edema, cartilage structure, and joint effusion. The study also aims to compare the safety of Cellular Matrix PRP-HA and HA.

Enrollment

58 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants fulfilling all of the inclusion criteria, listed below, are eligible to participate in this study:
Patients between 40 and 80 years (inclusive) of age
Femoro-tibial knee osteoarthritis defined
OA grade 2-3 according to the Kellgren & Lawrence grading scale, as defined on knee radiographs (less than 6 months old: Antero-posterior view; lateral view and skyline view)
Symptomatic knee osteoarthritis of a unilateral knee, characterized by pain at walking VAS ≥40 on a 0 to 100mm scale

*Bilateral knee osteoarthritis is allowed, provided the contralateral knee is characterized by a maximum pain at walkingof 30 on a 0 to 100 mm scale and doesn't require systemic analgesic treatment, with the exception of paracetamol up to the maximum dose of 4 g per day
Outpatient capableof walking 50 meters without assistance
Signature of the informed consent form
Capable of understanding the study's imperatives, as well as written instructions

Exclusion criteria

Grade < 2 or > 3 OA according to the Kellgren & Lawrence gradingscale
Viscosupplementation in the treatment site within the past 3 months
Patients suffering from femoropatellar osteoarthritis
Use of NSAIDs within the past 7 days
Corticosteroid injection in the treatment site within the past 3 months
Chronic use of corticosteroids (except those that are inhaled) or level III analgesics in the past 3 months and NSAID during the past month2 weeks
PRP or PRP/HA injection in the past 12 months
Any surgery of the knee planned within the next 12 months
Unstable knee injury
Systemic use of level III analgesics in the past 3 months
History of allergy to HA
Rheumatological disorders(exceptKOA)
Clinical evidence of local inflammation such as redness or heat of the joint
Current or medical history of autoimmunediseases
Surgery or arthroscopy surgery in the affected knee within the past 3 months
Local infection in the affected knee
Haematologic or clotting disorders (thrombocytopenia platelet count <150,000 platelets/µ) or blood coagulation (deficit-blood dyscrasia)
Anaemia (Haemoglobin <10g/dl)
Anticoagulant treatment or Antiaggregant treatment
Acute infection
Immunosuppressive states
Malignant disease
Recent fever (within previous 2 weeks) or serious disorders (liver disease, active gastroduodenal ulcer, digestive haemorrhage, etc.)
Pregnancy or breastfeeding or planning to become pregnant during the course of the study
Uncontrolled diabeted
Participation ongoing or in the past 3 months in another clinical trial
Participation in another OA clinical study in the past year
Refusal to sign or inability to give Informed Consent Inability to understand or comply with the requirements of the study