Knee Osteoarthristis
Conditions
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.
Interventions
BIOLOGICALHuman amniotic suspension allograft (ASA)
Human amniotic suspension allograft (ASA) intra-articular injection.
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between baseline, 1 week, and 1 ,3 ,6 ,12 months. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | The International Knee Documentation Committee Questionnaire is a knee-specific patient-reported outcome measure.The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity subscale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks patients one simple question: how is their knee at present versus how was their knee prior to injury? Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100, This final number is interpreted as a measure of function with higher scores representing higher levels of function. |
Contacts
Primary ContactKuan-Yu Lin
Backup ContactYin-Ming Huang
Outcome results
None listed