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CompletedNCT05722626Updated Feb 10, 2023

The Effects of Intra-articular Platelet-Rich Plasma Injection on The Severity of Knee Osteoarthritis

An interventional study of PRP and Normal Saline in Osteoarthritis, Knee, sponsored by Universitas Bali Internasional. Completed at 1 site in Indonesia. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by Universitas Bali Internasional · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2022, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

This is a single-center, randomized control trial The aim of this study is to compare PRP with placebo as the treatment of knee OA Conducted at Puri Raharja Hospital Bali in January-June 2022 Sample consisted of 106 patients with knee OA grades 2-3 Kellgren-Lawrence, randomized into PRP group and placebo group Samples were injected with 2 ml PRP or normal saline twice at one-week interval The severity of knee OA was assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before injection and two weeks after the first injection.

02

Conditions studied

  • Osteoarthritis, Knee
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 106 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

This is the only study on the registry with Universitas Bali Internasional as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

patients with knee pain for at least three months, aged between 40 to 80 years old, and whose results of radiological examination of the knee indicated OA grades 2-4 based on the Kellgren Lawrence classification

Exclusion criteria

Exclusion Criteria:

polyarticular rheumatic disease; knee arthroscopy \<1 year; intra-articular injection of hyaluronic acid (HA) or steroids in the past three months; current infection, diabetes, rheumatoid arthritis, coagulopathy disorders, anticoagulant or antiplatelet aggregation therapy, immunodeficiency disease, taking non-steroidal anti-inflammatory drugs (NSAIDs) two weeks prior to the procedure, knee trauma; inflammation; and tumors around the knee

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
106 participants (actual)

Study arms

  • Experimental
    Platelet-rich plasma

    PRP manufactured by T_Biyoteknoloji LTD, Turkey

    Procedure: PRP

  • Placebo comparator
    Normal Saline

    NaCl 0.9%

    Other: Normal Saline

Interventions

  • ProcedurePRP

    2 ml of platelet rich plasma intraarticular injection twice in one week interval

    Also known as: T_Biyoteknoloji LTD, Turkey

  • OtherNormal Saline

    NaCl 0.9%

    Also known as: NaCl 0.9%

06

What researchers measure

Primary outcomes

  1. WOMAC

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) based on questionnaire

    Time frame: 2 weeks

07

Study locations

1 site
  • Puri Raharja Hospital
    Denpasar, Bali, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05722626
Lead sponsor
Universitas Bali Internasional
Responsible party
Ida Ayu Ratih Wulansari Manuaba (Ida Ayu Ratih Wulansari Manuaba, Universitas Bali Internasional) — Principal investigator
First posted
Feb 10, 2023
Start date
Jan 1, 2022
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022
Last update
Feb 10, 2023

Study contacts

Anak Agung Sagung Mirah Prabandari, dr.
principal investigator · Warmadewa University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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