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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2021-07-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

platelet rich plasma + Hyaluronic acid

Intervention Type DRUG

Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.

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.

Group Type PLACEBO_COMPARATOR

platelet rich plasma + normal saline

Intervention Type DRUG

The normal salin as the placebo intervention was injection control group.

Interventions

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platelet rich plasma + Hyaluronic acid

Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.

Intervention Type DRUG

platelet rich plasma + normal saline

The normal salin as the placebo intervention was injection control group.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No