The Combination Effect of Platelet-rich Plasma and Hyaluronic Acid for Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: platelet rich plasma + Hyaluronic acid; Drug: platelet rich plasma + normal saline

• Registration Number: NCT03290365
• Lead Sponsor: Tri-Service General Hospital

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).

Study Timeline

• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-21
• Study Start: 2018-01-10
• Status Verified: 2021-07
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Last Update Submitted: 2021-07-10
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet rich plasma + Hyaluronic acid	platelet rich plasma + Hyaluronic acid	Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee. Patients received one dose of PRP injection. One week later, the one dose of HA is injected for intervention group.
Platelet rich plasma + normal saline	platelet rich plasma + normal saline	Patients received one dose of PRP injection. One week later, the one dose of normal saline is injected for control group.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital; 🇨🇳 Taipei, Neihu District, Taiwan