Osteoarthritis, Knee
Conditions
Brief summary
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.
Interventions
DEVICECellular Matrix
Group 1 (Cellular Matrix): Patients randomized to this group will be treated with two intra-articular injections of Cellular Matrix at D0 and M1.
DEVICEOrthovisc
Group 2 (HA): Patients randomized to this group will be treated with two intra-articular injections of HA alone provided by ORTHOVISC at D0 and M1
Sponsors
Changi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | Baseline, Month 1, Month 2, Month 6, Month 12 | Visual Analogue Score (VAS) on a scale of 0 to 10. 10 being the worst possible pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | Baseline, Month 1, Month 2, Month 6, Month 12 | EQ-5D-5L. It consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity: 1- no problem; 5- extreme problem |
| MRI | Baseline and Month 12 | Whole-Organ Magnetic Resonance Imaging Score (WORMS). WORMS evaluates 14 specific features. Each feature is scored on a scale: 0 = Normal; 1-6 = Increasing severity of abnormalities. |
| Function Score | Baseline, Month 1, Month 2, Month 6, Month 12 | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total WOMAC score is calculated by summing the scores from all three subscales: Pain, Stiffness, Physical Function. This can range from a minimum of 0 (indicating no symptoms) to a maximum of 96 (indicating severe symptoms). |
Countries
Singapore
Outcome results
None listed