Status:
UNKNOWN
Efficacy of Intra-articular Injection of Human Amniotic Suspension Allograft and Platelet-rich Plasma in the Treatment of Knee Osteoarthritis.
Lead Sponsor:
Kaohsiung Veterans General Hospital.
Conditions:
Knee Osteoarthristis
Eligibility:
All Genders
20-80 years
Phase:
NA
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...
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 we...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04698265
Start Date
January 1 2021
End Date
January 31 2023
Last Update
January 6 2021
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