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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

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

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Conditions studied

  • Osteoarthritis, Knee
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Who can participate

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

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.
  • Body mass index (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.
  • BMI >32.
  • Age >73 years.
  • Systemic autoimmune rheumatic diseases and blood disorders.
  • Active immunosuppressive or anticoagulant therapy.
  • Intra-articular injection to the knee within the previous 1 year or previous joint infection.
  • use of corticosteroids for 3 weeks before the procedure.
  • use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the 3 weeks before treatment.
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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

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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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

08

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 ↗

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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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