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Comparison of Two Application Regimens for Viscosupplementation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01824485
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
Viscosupplementation by intra-articular injection of hyaluronate products has recently gained popularity as a treatment modality of gonarthritis.There is not, however, a consensus on the best method.Our objective is to evaluate what is the best dosage of viscosupplementation with hyaluronic acid (OSTEONIL®) associated with 1 ml (20 mg) of triamcinolone hexacetonide. One hundred and four patients with knee osteoarthritis (KOA) were divides into 2 groups of 52 patients each to receive either a single application of 3 ampoules of OSTEONIL® + 1ml of Hexacetonide of triamcinolone or three applications of 1 ampoule of OSTEONIL®, one per week for three weeks + 1ml of Hexacetonide of triamcinolone only in the first injection. Primary endpoint was clinical results expressed by Visual Analogic Scale of pain (VAS), Western Ontario and Mcmaster Universities (WOMAC) and Lequesne questionaires at one, three, six and 12 months after the procedure

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: viscosupplementation 1+1+1 Drug: viscosupplementation 3 at once Phase 4

Detailed Description:

Viscosupplementation by intra-articular injection of hyaluronate products has recently gained popularity as a treatment modality of gonarthritis. Hyaluronic Acid is responsible for the elasticity and viscosity of the synovial fluid, protecting the joint. Biopsy studies show that besides the gain in pain and function, viscosupplementation may lead to structural changes of the cartilage. Currently there are several studies on the effect of intra-articular injection of hyaluronic acid in gonarthritis. There is not, however, a consensus on the best method. Regarding the substance to be injected, corticosteroids alone exhibit rapid results, but poor durability. Viscosupplementation shows more consistent results. However, especially when using derivatives with higher molecular weight hyaluronan, there is a significant number of patients that present an acute synovial reaction to viscosupplementation specially in the first cycle of three injections. The association triamcinolone injection with hyaluronic acid decreases the complaints in the first month of treatment. Our objective is to evaluate what is the best dosage of viscosupplementation with hyaluronic acid (OSTEONIL®) associated with 1 ml (20 mg) of triamcinolone hexacetonide by comparing two groups of patients with knee OA, the first with a single application of 3 ampoules and second with three applications, one per week for three weeks. One hundred and four knee osteoarthritis (KOA) patients, which are currently in usual care for KOA at the Osteometabolic Group - Department of Orthopedics and Traumatology - University of São Paulo General Hospital - will be assessed. After signing the informed consent, participants will respond WOMAC™, Lequesne™, VAS, SF-36 (quality of life) and subjective IKDC (International Knee Documentation Committee). The questionnaires and functional assessment will be performed before the procedure infiltration with 1month, 3 months, 6 months and 1 year of intervention.Twenty Patients will be submitted to evaluation using force platform and balance NeuroCom ®, with the following tests: weight support during the squat (weight bearing squat (WBS), one-leg support (unilateral stance (U.S.), from sitting to foot (sit to stand - STS). Previously, at 1 month, 3 month, 6 month and 12 months after the intervention.

Frontal weight-bearing, profile and axial radiographs will be performed to radiologically assess participants' knees.Patients will be randomly divided into two groups of 54 patients, (groups 1 and 2). Patients in group 1 (G1) will be submitted to viscosupplementation with 1 application of 3 vials of hyaluronic acid 20mg/2ml (OSTEONIL®) and 1 ml (20 mg) triamcinolone, whereas group 2 patients will be submitted to viscosupplementation with three applications of one ampoule of hyaluronic acid 20 mg/2ml (one per week for three weeks), with the first application of OSTEONIL® with 1 ml (20 mg) triamcinolone.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Best Effect of Viscosupplementation With Hyaluronic Acid and Triamcinolone in Patients With Knee Osteoarthritis. Prospective Randomized Study Between Two Different Applications Regimens
Study Start Date : March 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Group 2
Patients from Group 2 will receive an intra-articular injection of 1 ampoule (2ml) of OSTEONIL®, on a weekly basis, for 3 weeks (total of 3 injections)
Drug: viscosupplementation 1+1+1
intra-articular injection with 1 ampoule per week for 3 weeks
Other Name: 1+1+1

Experimental: Group 1
Patients from Group 1 will receive a single intra-articular injection of 3 ampoule (6ml) of OSTEONIL®
Drug: viscosupplementation 3 at once
single intra-articular injection with 3 ampoules




Primary Outcome Measures :
  1. WOMAC [ Time Frame: 6 months ]
    Pain and function assessment with WOMAC questionaire

  2. VAS [ Time Frame: 6 months ]
    Pain assessment with Visual Analogic Scale (VAS)

  3. LEQUESNE [ Time Frame: 6 months ]
    Pain and function assessment with Lequesne questionaire



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Met the American College of Rheumatology criteria for hip osteoarthritis
  • No knee intraarticular injections in the last 6 months

Exclusion Criteria:

  • Severe reaction to the procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824485


Locations
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Brazil
Instituto de Ortopedia e Traumatologia HC-FMUSP
São Paulo, SP, Brazil, 05410-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Marcia U Rezende, Phd FMUSP
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01824485    
Other Study ID Numbers: CAPPesq 0199/11
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: September 2013
Keywords provided by University of Sao Paulo General Hospital:
Osteoarthritis
Knee
Viscosupplementation
Clinical Trial
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases