Knee Osteoarthritis
Conditions
Keywords
Platelet rich plasma, Osteoarthritis of knee, Hyaluronic acid
Brief summary
Although platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for osteoarthritis of knee (OA knee), the combined effect of PRP with HA was not clear so far. Hence, investigator assess a prospective randomized double-blind controlled trial.
Detailed description
Patients with single or bilateral OA knee will be enrolled and randomized into intervention and control group. One dose of PRP is applied into both groups. One week later, one dose of HA is injected in intervention group and one dose of normal saline is injected in control group. Outcome measurements included visual analog scale (VAS)、Lequesne's severity index、Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)、balance test (Biodex) and analysis of synovial fluid at different follow-up frame (1st month, 3rd month, 6th month and 1 year after treatment).
Interventions
DRUGplatelet rich plasma + Hyaluronic acid
Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.
DRUGplatelet rich plasma + normal saline
The normal salin as the placebo intervention was injection control group.
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 50 to 75 y/o. 2. Alert consciousness 3. Symptom of knee osteoarthritis persist at least 6 months and stage I to III scored by Ahlbäck grading system 4. The pain score measured by VAS at least 4 points
Exclusion criteria
1. Has received hyaluronic acid, PRP or steroid injection within 6 months 2. Has received NSAIDs or steroid within one week 3. Tumor or metastasis surrounding the knee joint 4. Has received total knee replacement, major surgery in knee, rheumatoid arthritis 5. Patient who cant tolerance the balance test. 6. Thrombocytopenia or coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection. | Pre-treatment, 1st month, 3rd month, 6th month and one year after injection. | Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) to measure the symptoms and functional status before treatment and multiple time frame after treatment. Both subscales has the scores ranged from 1 to 5 for each item and a higher score indicating more severe of symptom or impaired functional status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in severity of symptoms and functional status on 1st month, 3rd month, 6th month and one year after injection. | Pre-treatment, 1st month, 3rd month, 6th month and one year after injection. | Using the Lequesne's severity index to measure the symptoms and functional status before treatment and multiple time frame after treatment. A higher score indicate more severe. |
| Change from baseline of pain on 1st month, 3rd month, 6th month and one year after injection. | Pre-treatment, 1st month, 3rd month, 6th month and one year after injection. | Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. The score ranging from 10 (remarkable pain) to 0 (no pain). |
| Change from baseline in balance function on 1st month, 3rd month, 6th month and one year after injection. | Pre-treatment, 1st month, 3rd month, 6th month and one year after injection. | Using the balance test (Biodex) to measure the balance function before treatment and multiple time frame after treatment. |
| Change from baseline in analysis of synovial fluid on 6th month and one year after injection. | Pre-treatment, 6th month and one year after injection. | The synovial fluid is aspirated to measure the parameters before treatment and multiple time frame after treatment. |
Countries
Taiwan
Outcome results
None listed