Efficacy of Intra-articular Injection of Human Amniotic Suspension Allograft and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis.

Comparison of the Efficacy of Intra-articular Injection of Human Amniotic Suspension Allograft and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis: A Prospective, Double-blind, Randomized Controlled Trial

A double-blind, randomized controlled trial designed to evaluate the symptomatic modulating efficacy of amniotic suspension allograft (ASA) in comparison to platelet-rich plasma (PRP), hyaluronic acid (HA) and normal saline (NS) in the injection treatment of knee osteoarthritis. The hypothesis is that ASA would provide the greatest functional improvement.

At least 150 subjects with osteoarthritic knee will be recruited and computer randomized 1:1:1:1 to single injection of ASA (40mg), ASA (20mg), PRP + HA, and NS groups. Both subjects and evaluaters were blinded to allocations. Functional and radiologic outcomes were measured at baseline, and 1 week, 1, 3, 6, 12 months postinjection.

Inclusion Criteria:

• Age between 20 and 80 years
• Ability to provide informed consent
• Unilateral or bilateral knee VAS pain score ≥ 4 of 10 (worst possible pain) for more than 4 months
• Diagnosis of OA Kellgren-Lawrence I-III by radiography (triple-film of bilateral lower limb, standard knee anterior-posterior view in full extension, lateral view in 30-degrees flexion, and 45°Merchant views)
• No prior PRP injection of knee
• No prior surgical procedure of the participating knee
• BMI<40 kg/m2

Exclusion Criteria:

• Lawrence stage IV
• Major axial deviation (varus> 5°, valgus > 5°)
• Any concomitant symptomatic knee disorder (i.e. ligamentous/ meniscal injury)
• Systemic inflammatory arthropathy
• Hematologic diseases
• Severe cardiovascular disease
• Neurological disorders
• Active infection
• Immuno-compromised
• Therapy with anticoagulants or antiaggregants
• Use of NSAIDs and/or chondroprotective supplements, such as glucosamines and chondroitin sulfates, within 7 days prior to trial
• Recent intra-articular injection of corticosteroids (within 30 days)
• Prior treatment with HA in past 6 monthsHb< 11 g/dL
• Platelet count < 150,000/mm3