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

Knee Osteoarthritis Clinical Trial

Official title:

The Combination Long-term Effect of Platelet-rich Plasma and Hyaluronic Acid in Patients With Knee Osteoarthritis: a Prospective Randomized Double-blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290365
• Other study ID #: PRP and HA for OA knee
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2021
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• platelet rich plasma + Hyaluronic acid
Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.
• platelet rich plasma + normal saline
The normal salin as the placebo intervention was injection control group.

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital	Taipei	Neihu District

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Abate M, Verna S, Schiavone C, Di Gregorio P, Salini V. Efficacy and safety profile of a compound composed of platelet-rich plasma and hyaluronic acid in the treatment for knee osteoarthritis (preliminary results). Eur J Orthop Surg Traumatol. 2015 Dec;25 — View Citation

Chen SH, Kuan TS, Kao MJ, Wu WT, Chou LW. Clinical effectiveness in severe knee osteoarthritis after intra-articular platelet-rich plasma therapy in association with hyaluronic acid injection: three case reports. Clin Interv Aging. 2016 Sep 8;11:1213-1219 — View Citation

Dallari D, Stagni C, Rani N, Sabbioni G, Pelotti P, Torricelli P, Tschon M, Giavaresi G. Ultrasound-Guided Injection of Platelet-Rich Plasma and Hyaluronic Acid, Separately and in Combination, for Hip Osteoarthritis: A Randomized Controlled Study. Am J Sp — View Citation

Lana JF, Weglein A, Sampson SE, Vicente EF, Huber SC, Souza CV, Ambach MA, Vincent H, Urban-Paffaro A, Onodera CM, Annichino-Bizzacchi JM, Santana MH, Belangero WD. Randomized controlled trial comparing hyaluronic acid, platelet-rich plasma and the combin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in severity of symptoms and functional status on 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.	Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Secondary	Change from baseline in severity of symptoms and functional status on 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.	Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Secondary	Change from baseline of pain on 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).	Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Secondary	Change from baseline in balance function on 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.	Pre-treatment, 1st month, 3rd month, 6th month and one year after injection.
Secondary	Change from baseline in analysis of synovial fluid on 6th month and one year after injection.	The synovial fluid is aspirated to measure the parameters before treatment and multiple time frame after treatment.	Pre-treatment, 6th month and one year after injection.