ClinicalTrials.gg
CompletedNCT03329235Updated Nov 1, 2017

Intraosseous With Intra-articular Injection of Platelet Rich Plasma in Treatment of Knee Osteoarthritis

An Early Phase 1 interventional study of PRP and HA in Osteoarthritis, Knee, sponsored by Cangzhou Central Hospital. Completed. Open to participants aged 40 Years to 73 Years. Per ClinicalTrials.gov, last updated 2017-11-01.

Sponsored by Cangzhou Central Hospital · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jan 2015, registered Mar 2017).

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Phase
Early Phase 1
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
40 Years to 73 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 43 studies testing platelet rich plasma in Osteoarthritis, Knee — 3 open to participants now, 4 under way, 1 of them phase 3. platelet rich plasma · Osteoarthritis, Knee.

Enrollment
17th of 43
86 · median 60
Started
2015
the only one that year
Phase 1
5 of 43
none open now
Registered
14th of 43
by date
Lead sponsor
1 of 43
Cangzhou Central Hospital

Among the 43 studies testing platelet rich plasma in Osteoarthritis, Knee, this one is the 17th largest by enrollment, is the only one that started in 2015, is one of 5 in phase 1, and was the 14th registered.

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 621 are open to participants now.

Browse Osteoarthritis, Knee studies →

Open to participants now

3 of the 43 studies testing platelet rich plasma in Osteoarthritis, Knee are open now, in 3 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

About platelet rich plasma

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.

This study: 40 Years to 73 Years · all sexes · no healthy volunteers.

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02

Study summary

The aim of this study was to compare the efficacy of treatment in three groups of patients with knee osteoarthritis (OA) given a combination of intraosseous with intra-articular injection of platelet rich plasma (PRP), intra-articular injection of PRP and a single application of hyaluronic acid (HA).

Read the detailed description

Methods Eighty-six patients from January 2015 to June 2015 with grade II to grade III knee osteoarthritis according to the Kellgren-Lawrence classification were randomly divided into 3 groups to receive either PRP or HA. Group A received intra-articular injection of PRP 2 ml combination with medial tibial plateau and medial femoral condyle injection of PRP 2 ml (once more 2 weeks later). Group B were treated with 2 ml of PRP intra-articular injection every 14 days for a total of two injections. Group C received intra-articular injection of hyaluronic acid 2 ml every 7 days for five injections. All patients were evaluated by the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities (WOMAC) score before the treatment and at 1st, 3rd, 6th, 12th and 18th months.

03

Conditions studied

  • Osteoarthritis, Knee
04

Who can participate

Ages eligible
40 Years to 73 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Unilateral symptomatic knee with pain for at least 1 month or swelling.
  • Radiographic findings of knee degeneration (Kellgren-Lawrence score of II - III).
  • Age 40-73 years.
  • (BMI) 18-32.5).
  • Knee stability without a severe trauma history.

Exclusion criteria

Exclusion Criteria:

  • Bilateral knee osteoarthritis indicative of treatment for both knees.
  • Kellgren-Lawrence score greater than III.
  • >32.
  • Age >73 years.
  • Systemic rheumatic diseases and blood disorders.
  • Active or anticoagulant therapy.
  • Intra-articular injection to the knee within the previous 1 year or previous joint infection.
  • use of for 3 weeks before the procedure.
  • use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the 3 weeks before treatment.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Intraosseous and intra-articular

    injection of PRP 2 ml

    Drug: PRP

  • Active comparator
    intra-articular PRP

    injection PRP 2 ml

    Drug: PRP

  • Active comparator
    Intra-articular injection of HA

    injection of HA 2 ml

    Drug: HA

Interventions

  • DrugPRP

    platelet rich plasma

  • DrugHA

    hyaluronic acid

06

What researchers measure

Primary outcomes

  1. WOMAC scores

    The evaluation was performed with WOMAC, which were recorded on a five-point Likert scale scoring, with a response of "none" scored as 0, "mild" as 1, "moderate" as 2, "severe" as 3 and "extreme" as 4.

    Time frame: At the 18th month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2015 to primary completion in Jun 2015, 5 months.

Of 61 phase 1 interventional studies under Osteoarthritis, Knee, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2017
First posted
Nov 1, 2017
StartActual
Jan 1, 2015
Primary completionActual
Jun 30, 2015
CompletionActual
Jan 1, 2017
Last update
Nov 1, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03329235
Lead sponsor
Cangzhou Central Hospital
Responsible party
Sponsor
First posted
Nov 1, 2017
Start date
Jan 1, 2015
Primary completion
Jun 30, 2015
Completion
Jan 1, 2017
Last update
Nov 1, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Platelet rich plasma

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