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

Knee Osteoarthristis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04698265
• Other study ID #: KSVGH20-CT9-11, ASA RCT 1.0
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: January 2021
• Source: Kaohsiung Veterans General Hospital.
• Contact: Kuan-Yu Lin
• Phone: +886-7-3422121
• Email: johnkyl[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthristis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Human amniotic suspension allograft (ASA)
Human amniotic suspension allograft (ASA) intra-articular injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	Baseline, 1 week, 1,3,6,12 months