Cingal Study for Knee Osteoarthritis

Anika Therapeutics

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Device: Hyaluronic Acid and TH (Cingal®); Device: Hyaluronic Acid (Monovisc®); Device: Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01891396

Cingal 13-01

Details and patient eligibility

About

The purpose of this study is to see if a single injection of Cingal into the knee provides safe relief of pain caused by osteoarthritis.

Full description

This study compared three groups of subjects. Group One received a single injection of Cingal (Hyaluronic Acid plus Triamcinolone Hexacetonide). Group Two received a single injection of Monovisc (Hyaluronic Acid). Group Three received a single injection of saline as a placebo.

Enrollment: 368 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is 40 - 75 years old with a Body Mass Index (BMI)≤ 40 kg/m2
• Subject has Kellgren-Lawrence (K-L) severity grade I, II, or III in the index knee as determined by X-Ray. Contralateral knee: K-L severity grade 0, I, or II.

Exclusion criteria

• Subject received an intra-articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the informed consent form (ICF).
• Subject had an arthroscopy of either knee within 3 months of signing the informed consent form (ICF).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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368 participants in 3 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

Single injection of 0.9% saline supplied as a 4 milliliter (mL) unit dose in a 5mL glass syringe

Treatment:

Device: Saline

Hyaluronic Acid and TH (Cingal®)

Experimental group

Description:

Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 milliliter (mL) unit dose in a 5 mL glass syringe

Treatment:

Device: Hyaluronic Acid and TH (Cingal®)

Hyaluronic Acid (Monovisc®)

Active Comparator group

Description:

Single injection of sodium hyaluronate supplied as a 4 milliliter (mL) unit dose in a 5 mL glass syringe

Treatment:

Device: Hyaluronic Acid (Monovisc®)