Status:
COMPLETED
Cingal Study for Knee Osteoarthritis
Lead Sponsor:
Anika Therapeutics, Inc.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
NA
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 (Hyal...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT01891396
Start Date
June 1 2013
End Date
September 1 2014
Last Update
June 1 2023
Active Locations (27)
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1
Orthopaedics Clinic Multiprofile Hospital for Active Treatment "Sveti Georgi"
Plovdiv, Bulgaria
2
Clinic of Orthopaedics and Traumatology, University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna"
Sofia, Bulgaria
3
Consultative Outpatients' Medical Office for Rheumatologic Diseases
Sofia, Bulgaria
4
Department of Orthopaedics and Traumatology Multiprofile Hospital for Active Treatment Lyulin Hospital
Sofia, Bulgaria