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

Sponsor
Cangzhou Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03329235
Collaborator
(none)
86
3
24

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Intraosseous With Intra-articular Injection of Platelet Rich Plasma Versus Hyaluronic Acid in Treatment of Knee Osteoarthritis
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jun 30, 2015
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intraosseous and intra-articular

injection of PRP 2 ml

Drug: PRP
platelet rich plasma

Active Comparator: intra-articular PRP

injection PRP 2 ml

Drug: PRP
platelet rich plasma

Active Comparator: Intra-articular injection of HA

injection of HA 2 ml

Drug: HA
hyaluronic acid

Outcome Measures

Primary Outcome Measures

  1. WOMAC scores [At the 18th month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 73 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cangzhou Central Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cangzhou Central Hospital
ClinicalTrials.gov Identifier:
NCT03329235
Other Study ID Numbers:
  • Cangzhou Central Hospital
First Posted:
Nov 1, 2017
Last Update Posted:
Nov 1, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2017