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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthristis
- Sponsor
- Kaohsiung Veterans General Hospital.
- Enrollment
- 150
- Primary Endpoint
- Change of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between baseline, 1 week, and 1 ,3 ,6 ,12 months.
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Yin Ming, Huang
Chief resident of Orthopedic.
Kaohsiung Veterans General Hospital.
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between baseline, 1 week, and 1 ,3 ,6 ,12 months.
Time Frame: Baseline, 1 week, 1,3,6,12 months
WOMAC is a self-administered questionnaire consisting of 24 items divided into 3 subscales:(1) Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright(2) Stiffness (2 items): after first waking and later in the day(3) Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic dutiesThe test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
Secondary Outcomes
- Change of the International Knee Documentation Committee (IKDC Questionnaire) between baseline, 1 week, and 1 ,3 ,6 ,12 months.(Baseline, 1 week, 1,3,6,12 months)