Back to resultsIntraosseous With Intra-articular Injection of Platelet Rich Plasma in Treatment of Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
PRP
HA
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
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:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Intraosseous and intra-articular
intra-articular PRP
Intra-articular injection of HA
Arm Description
injection of PRP 2 ml
injection PRP 2 ml
injection of HA 2 ml
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03329235
First Posted
March 3, 2017
Last Updated
October 31, 2017
Sponsor
Cangzhou Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03329235
Brief Title
Intraosseous With Intra-articular Injection of Platelet Rich Plasma in Treatment of Knee Osteoarthritis
Official Title
Intraosseous With Intra-articular Injection of Platelet Rich Plasma Versus Hyaluronic Acid in Treatment of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
January 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cangzhou Central Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraosseous and intra-articular
Arm Type
Experimental
Arm Description
injection of PRP 2 ml
Arm Title
intra-articular PRP
Arm Type
Active Comparator
Arm Description
injection PRP 2 ml
Arm Title
Intra-articular injection of HA
Arm Type
Active Comparator
Arm Description
injection of HA 2 ml
Intervention Type
Drug
Intervention Name(s)
PRP
Intervention Description
platelet rich plasma
Intervention Type
Drug
Intervention Name(s)
HA
Intervention Description
hyaluronic acid
Primary Outcome Measure Information:
Title
WOMAC scores
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Intraosseous With Intra-articular Injection of Platelet Rich Plasma in Treatment of Knee Osteoarthritis
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