Clinical trial NCT04698265: Efficacy of Intra-articular Injection of Human Amniotic Suspension Allograft and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthristis
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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
* 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

Primary outcomes:
measure: Change of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between baseline, 1 week, and 1 ,3 ,6 ,12 months.
timeFrame: Baseline, 1 week, 1,3,6,12 months
Secondary outcomes:
measure: Change of the International Knee Documentation Committee (IKDC Questionnaire) between baseline, 1 week, and 1 ,3 ,6 ,12 months.
timeFrame: Baseline, 1 week, 1,3,6,12 months
Other outcomes:
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