Efficacy and Safety of Repeated Intraarticular Injections of Hyaluronic Acid in Patients With OA of the Knee

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

446 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2009-12-31

Brief Summary

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The main objective is the long-term comparison (3 years and 4 months) of the efficacy and safety of repeated intra-articular administration of hyaluronic acid in the treatment of osteoarthritis of the knee.

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Detailed Description

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To evaluate the efficacy and safety of repeated injections of hyaluronic acid compared with placebo over a period of 40 months.

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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hyaluronic acid

Cycles of 5 injections of hyaluronic acid at specified intervals

Group Type EXPERIMENTAL

Hyaluronic acid

Intervention Type DEVICE

3 cycles of 5 hyaluronic acid injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year

Placebo

Cycles of 5 injections of saline at specified intervals

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

3 cycles of 5 saline solution injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year

Interventions

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Hyaluronic acid

3 cycles of 5 hyaluronic acid injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year

Intervention Type DEVICE

Placebo

3 cycles of 5 saline solution injections, with a 6 month interval between each one. A 4th treatment cycle of five injections will be carried out at the end of one year

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient \> 45 years of age
* Out-patient diagnosed with primary osteoarthritis of the femorotibial medial joint of the knee with clinical and radiological (Kellgren grade II-III) ACR diagnosis
* Joint Space Width (JSW) \> 2mm
* Overall pain greater or equal to 55mm (VAS - Visual Analogue Scale 100mm) recorded in the knee,by the patient at any time during the week prior to the evaluation

Exclusion Criteria

* Overweight patients (body mass index \> 32).
* Pregnant and lactating women. Women of child-bearinge age not using effective contraception
* Patients who have received intra-articular hyaluronic acid within the previous year and/or intra-articular steroids or articular lavage in the chosen knee,within the previous 3 months prior to their inclusion in the study.
* AINE administration within the 14 days prior to their inclusion in the study.
* Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
* Immunocompromised patients or patients receiving systemic immunosuppressive therapy.
* Patients with known sensitivity to HA, parcetamol or AINEs permitted as rescue medication.
* Patients who have received any investigational drug within 30 days prior to visit 1, or who are scheduled for the administration of an investigational drug other than the protocol product during this study.
* Patients with severely impaired central nervous system.
* Patients with coagulation alterations, despite receiving treatment.
* Patients with secondary osteoarthritis of the knee
* Patients having previously received surgery, including arthroscopy
* Patients with articular inflammatory disease

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No