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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human amniotic suspension allograft (ASA), 40 mg | Experimental | Human amniotic suspension allograft (ASA) contains particulated human amniotic membrane and cells derived from the amniotic fluid. The allograft is freeze-dried, terminally sterilized with low dose gamma irradiation. Arm 1 uses 40 mg ASA stored in a sterile vial (Amniogen, HTC Regenerative Ltd. New Taipei, Taiwan). |
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| Human amniotic suspension allograft (ASA), 20 mg | Experimental | Human amniotic suspension allograft (ASA) contains particulated human amniotic membrane and cells derived from the amniotic fluid. The allograft is freeze-dried, terminally sterilized with low dose gamma irradiation. Arm 2 uses 20 mg ASA stored in a sterile vial (Amniogen, HTC Regenerative Ltd. New Taipei, Taiwan). |
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| CellularMatrix (a combination of platelet-rich plasma and hyaluronic acid) | Experimental | CellularMatrix (RegenLab SA, Switzerland) is composed of sterile and non-pyrogenic tubes allowing the mix of Platelet Rich Plasma (PRP) with Hyaluronic Acid (HA) in the same proportion (2mL of PRP for 2mL of HA). |
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| Normal saline | Placebo Comparator | 4ml of normal saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human amniotic suspension allograft (ASA) | Biological | Human amniotic suspension allograft (ASA) intra-articular injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) between baseline, 1 week, and 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). | Baseline, 1 week, 1,3,6,12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the International Knee Documentation Committee (IKDC Questionnaire) between baseline, 1 week, and 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuan-Yu Lin | Contact | +886-7-3422121 | 3051 | johnkyl@yahoo.com |
| Yin-Ming Huang | Contact | +886-7-3422121 | 3051 | rex781104@hotmail.com |
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We do not have the plan to make individual participant data (IPD) available to other researchers.
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| Baseline, 1 week, 1,3,6,12 months |