Knee Osteoarthritis
Conditions
Brief summary
To compare the efficacy and structural change of intraarticular single platelet-rich plasma(PRP) versus novel crosslinked Hyaluronic Acid(HA)(HyajointPlus) for the treatment of early stage knee osteoarthritis(OA). This was a prospective, double-blind, RCT with an allocation ratio of 1:1.
Detailed description
In the PRP group, an Aeon Acti-PRP set was used and an approximately 4-mL PRP volume was yielded and was used in a single-dose treatment. In the HA group, HYAJOINT Plus containing 60 mg of purified sodium hyaluronate was used in a single-dose treatment. All PRP and HA injection syringes were covered with opaque envelop, and the intra-articular injection procedure was performed by the same physician without ultrasound or other imaging guidance.
Interventions
COMBINATION_PRODUCTPlatelet Rich Plasma
In the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given.
COMBINATION_PRODUCTHyaluronic Acid
In the Hyaluronic group, 3mLHYAJOINT Plus was given.
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. patients older than 50 years 2. a diagnosis of primary knee osteoarthritis 3. Kellgren-Lawrence (K-L) grading scale smaller than 3 4. both male and female.
Exclusion criteria
1. patients younger than 50 years of age 2. K-L grade 3 or more 3. history or active presence of clinically significant inflammatory articular or rheumatic disease other than OA 4. generalized OA 5. the detection of rapidly progressive OA before the start of the trial 6. underwent any previous lower extremity surgery 7. excessive mechanical axis deviation (varus \> 5°, valgus \> 5°) 8. body mass index larger than 30 9. history or presence of malignant disorders 10. systemic disorders such as diabetes mellitus, severe cardiovascular diseases, hematologic diseases, immune-deficiencies, and infections 11. systematic or intra-articular corticosteroid therapy in the previous 3 months 12. prior treatment with HA in the past 6 months 13. anticoagulants or antiaggregants therapy in the preceding 30 days 14. non-steroidal anti-inflammatory medications in the preceding 7 days 15. platelet count less than 150,000/ml of blood 16. hemoglobin values less than 12g/dL of blood.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of Western Ontario and McMaster Universities Index (WOMAC) score from baseline | Baseline and 1-month, 3-month, 6-month after injection | The minimum value of Western Ontario and McMaster Universities Index (WOMAC) score is zero and the maximum is 96, whether higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of Knee Cartilage Grading System from baseline | Baseline and 1-month, 3-month, 6-month after injection | The Cartilage Grading System classifies the cartilage from grades 0 to 6 according to parameters of sharpness, clarity and thickness change of the cartilage band. Grade 0 refers to normal and healthy cartilage, while grade 6 refers to severely eroded cartilage, whether higher scores mean a worse outcome. |
| The change of Knee Cartilage strain ratio from baseline | Baseline and 1-month, 3-month, 6-month after injection | The strain represents the elasticity. We used the overlying soft tissue as reference. Larger strain ratio means the cartilage is softer, while smaller strain ratio means the cartilage is harder. |
| The change of MRI Osteoarthritis Knee Score (MOAKS) from baseline | Baseline and 6-month after injection | Fourteen subregions are defined for scoring of articular cartilage and bone marrow lesions in cluding patella, femur and tibia region. Grade 0 refers to normal and healthy cartilage without loss, while grade 3 refers \>75% cartilage full thickness loss, whether higher scores mean a worse outcome. |
Countries
Taiwan
Outcome results
None listed