Clinical trial NCT01891396: Cingal Study for Knee Osteoarthritis
Official title: A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Hyaluronic acid
HA Injection
Steroid Injection
Knee injection
Lead sponsor: Anika Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-03
Enrollment: 368
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)
timeFrame: 12 Weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (PP)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT)
timeFrame: 1 Week
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT)
timeFrame: 3 Weeks
measure: OMERACT-OARSI Responder Index Comparing Cingal® to Saline (ITT)
timeFrame: 12 Weeks
measure: Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT)
timeFrame: 12 Weeks
measure: Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT)
timeFrame: 1 Week
measure: Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT)
timeFrame: 3 Weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)
timeFrame: 26 Weeks
measure: Evaluator Global Assessment Comparing Cingal® to Saline (ITT)
timeFrame: 12 Weeks
measure: Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT)
timeFrame: 1 Week
measure: Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT)
timeFrame: 3 Week
measure: Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT)
timeFrame: 26 Weeks
measure: Evaluator Global Assessment Comparing Cingal® to Saline (ITT)
timeFrame: 26 Weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP)
timeFrame: 1 Week
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP)
timeFrame: 3 Weeks
measure: OMERACT-OARSI Responder Index Comparing Cingal® to Saline (PP)
timeFrame: 12 Weeks
measure: Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP)
timeFrame: 12 Weeks
measure: Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP)
timeFrame: 1 Week
measure: Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP)
timeFrame: 3 Weeks
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline. (PP)
timeFrame: 26 Weeks
measure: Evaluator Global Assessment Comparing Cingal® to Saline (PP)
timeFrame: 12 Weeks
measure: Evaluator Global Assessment Comparing Cingal® and Monovisc® (PP).
timeFrame: 1 Week
measure: Evaluator Global Assessment Comparing Cingal® to Monovisc® (PP)
timeFrame: 3 Week
measure: Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP)
timeFrame: 26 Weeks
measure: Evaluator Global Assessment Comparing Cingal® to Saline (PP)
timeFrame: 26 Weeks
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Orthopaedics Clinic Multiprofile Hospital for Active Treatment "Sveti Georgi"
city: Sofia
country: Bulgaria
facility: Clinic of Orthopaedics and Traumatology, University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna"
city: Sofia
country: Bulgaria
facility: Consultative Outpatients' Medical Office for Rheumatologic Diseases
city: Sofia
country: Bulgaria
facility: Department of Orthopaedics and Traumatology Multiprofile Hospital for Active Treatment Lyulin Hospital
city: Sofia
country: Bulgaria
facility: Department of Orthopaedics Traumatology - Tokuda Hospital Sofia
city: Red Deer
country: Canada
facility: Red Deer Regional Hospital Center
state: Alberta
city: Oakville
country: Canada
facility: Deakon Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: Sports Medicine Specialists
state: Ontario
city: Halifax
country: Canada
facility: QEII Health Sciences
city: Brno
country: Czechia
facility: Revmacentrum MUDr. Moster, s.r.o.
city: Plzen
country: Czechia
facility: Faculty Hospital Plzen
city: Prague
country: Czechia
facility: Institute of Rheumatology
city: Prague
country: Czechia
facility: Thomayer Hospital Rheumatology Department
city: Uherske Hradiste
country: Czechia
facility: Medical Plus s.r.o.
city: Budapest
country: Hungary
facility: Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Orthopaedic Clinic
city: Budapest
country: Hungary
facility: Uzsoki Hospital, Department of Traumatology
city: Gyor
country: Hungary
facility: Petz Aladar County Teachin Hospital, Traumatology, Orthopaedics and Hand Surgery Centre
city: Kecskemet
country: Hungary
facility: Jutrix Medical LLC
city: Kiskunfelegyhaza
country: Hungary
facility: Medidea Bt.
city: Mako
country: Hungary
facility: G&V Pharma-Med Bt.
city: Bialystok
country: Poland
facility: Osteo-Medic s.c.
city: Gliwice
country: Poland
facility: NZOZ Medi SPATX
city: Kielce
country: Poland
facility: ARTIMED Niepubliczny Zakład Opieki Zdrowotnej
city: Krakow
country: Poland
facility: CenterMed Krakow Sp. x. o.o.
city: Lodz
country: Poland
facility: Radlinski Regional Centre of Orthopeadics and Rehabilitation of Locomotor Organs
city: Sopot
country: Poland
facility: Wojewódzki Zespół Reumatologiczny im. Dr Jadwigi Titz-Kosko
Study officials:
affiliation: Uzsoki Hospital
name: Laszlo Hangody, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.