Cingal Study for Knee Osteoarthritis

NCT ID: NCT01891396

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 368 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-09-30

Brief Summary

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.

Detailed 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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Saline

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DEVICE

Saline placebo packaged to look identical to comparator syringes. Injection into knee.

Hyaluronic Acid and TH (Cingal®)

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

Group Type: EXPERIMENTAL

Hyaluronic Acid and TH (Cingal®)

Intervention Type: DEVICE

Injection into knee

Hyaluronic Acid (Monovisc®)

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

Group Type: ACTIVE_COMPARATOR

Hyaluronic Acid (Monovisc®)

Intervention Type: DEVICE

Injection into knee

Interventions

Hyaluronic Acid and TH (Cingal®)

Injection into knee

Intervention Type: DEVICE

Hyaluronic Acid (Monovisc®)

Injection into knee

Intervention Type: DEVICE

Saline

Saline placebo packaged to look identical to comparator syringes. Injection into knee.

Intervention Type: DEVICE

Other Intervention Names

Cingal®; Monovisc®

Eligibility Criteria

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anika Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laszlo Hangody, MD

Role: PRINCIPAL_INVESTIGATOR

Uzsoki Hospital

Locations

Orthopaedics Clinic Multiprofile Hospital for Active Treatment "Sveti Georgi"

Plovdiv, , Bulgaria

Clinic of Orthopaedics and Traumatology, University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna"

Sofia, , Bulgaria

Consultative Outpatients' Medical Office for Rheumatologic Diseases

Sofia, , Bulgaria

Department of Orthopaedics and Traumatology Multiprofile Hospital for Active Treatment Lyulin Hospital

Sofia, , Bulgaria

Department of Orthopaedics Traumatology - Tokuda Hospital Sofia

Sofia, , Bulgaria

Red Deer Regional Hospital Center

Red Deer, Alberta, Canada

Deakon Medicine Professional Corporation

Oakville, Ontario, Canada

Sports Medicine Specialists

Toronto, Ontario, Canada

QEII Health Sciences

Halifax, , Canada

Revmacentrum MUDr. Moster, s.r.o.

Brno, , Czechia

Faculty Hospital Plzen

Pilsen, , Czechia

Institute of Rheumatology

Prague, , Czechia

Thomayer Hospital Rheumatology Department

Prague, , Czechia

Medical Plus s.r.o.

Uherské Hradiště, , Czechia

Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic

Budapest, , Hungary

Semmelweis Egyetem Orthopaedic Clinic

Budapest, , Hungary

Uzsoki Hospital, Department of Traumatology

Budapest, , Hungary

Petz Aladar County Teachin Hospital, Traumatology, Orthopaedics and Hand Surgery Centre

Győr, , Hungary

Jutrix Medical LLC

Kecskemét, , Hungary

Medidea Bt.

Kiskunfélegyháza, , Hungary

G&V Pharma-Med Bt.

Makó, , Hungary

Osteo-Medic s.c.

Bialystok, , Poland

NZOZ Medi SPATX

Gliwice, , Poland

ARTIMED Niepubliczny Zakład Opieki Zdrowotnej

Kielce, , Poland

CenterMed Krakow Sp. x. o.o.

Krakow, , Poland

Radlinski Regional Centre of Orthopeadics and Rehabilitation of Locomotor Organs

Lodz, , Poland

Wojewódzki Zespół Reumatologiczny im. Dr Jadwigi Titz-Kosko

Sopot, , Poland

Countries

Bulgaria; Canada; Czechia; Hungary; Poland

References

Hangody L, Szody R, Lukasik P, Zgadzaj W, Lenart E, Dokoupilova E, Bichovsk D, Berta A, Vasarhelyi G, Ficzere A, Hangody G, Stevens G, Szendroi M. Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial. Cartilage. 2018 Jul;9(3):276-283. doi: 10.1177/1947603517703732. Epub 2017 May 23.

Reference Type: RESULT

PMID: 28535076 (View on PubMed)

Other Identifiers

Cingal 13-01

Identifier Type: -

Identifier Source: org_study_id