| Biovation are pleased to announce that there is currently an ongoing a motion study with the use of Cartiva™. |
| For more details please visit http://clinicaltrials.gov/ct2/show/NCT00969969?term=carticept&rank=2 |
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| Cartiva MOTION Study Update – United Kingdom |
| "A Prospective, Randomized, Non-Inferiority Study to Evaluate the Safety and Effectiveness of Cartiva™ Synthetic Cartilage Implant in the Treatment of First Metatarsophalangeal Joint Osteoarthritis as Compared to a Control" (Cartiva MOTION Study) |
| Study Overview |
- Phase III randomized, prospective non-inferiority study to evaluate Cartiva versus arthrodesis in the treatment of degenerative 1st MTP OA
- 230 patients randomized in a 2:1 allocation of Cartiva to arthrodesis
- Primary composite endpoint consisting of pain, function and safety components to be evaluated at 12 and 24 months
- Assessments include VAS pain scale, patient completed assessments for foot function and quality of life, foot exams, range of motion measurements and independent radiographic evaluations
- Follow up at 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years
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| Overall study PI – Dr. Judy Baumhauer, University of Rochester, New York, USA |
| Canadian Sites |
- Dr. Tim Daniels – St. Michael’s Hospital, Toronto, ON (site 02)
- Dr. Mark Glazebrook – Queen Elizabeth II Health Sciences Centre, Halifax, NS (site 03)
- Dr. Alistar Younger – St. Paul’s Hospital, Vancouver, BC (site 04)
- Dr. Ian Le – University of Calgary, Calgary, BC (site 05)
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| UK Sites |
- Mr. Dishan Singh – Royal National Orthopaedic Hospital in Stanmore (site 6)
- Mr. Anthony Sakellariou – Frimley Park Hospital in Camberley (site 7)
- Mr. Chris Blundell – Sheffield Orthopaedics in Sheffield (site 8)
- Mr. Matthew Solan – Royal Surrey County Hospital in Guildford (site 9)
- Mr. Dominic Nielsen – St. George’s Hospital in London and Southwest London Elective Orthopaedics Center in Epsom (site 10)
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| Enrollment to Date |
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| Study Population Demographics |
- 84% Female and 16% Male
- Mean age 57 years
- Mean baseline VAS pain score of 67
- Grade 2 – 24%, Grade 3 – 64%, Grade 4 – 11%
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