| Cartiva MOTION Study |
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| A Prospective, Non-Inferiority Study to Evaluate the Effectiveness of Cartiva™ Synthetic Cartilage Implant in the Treatment of First Metatarsophalangeal Joint Osteoarthritis as Compared to a Concurrent Control. |
| For study design synopsis, inclusion and exclusion criteria and a list of participating study sites, please visit: www.clinicaltrials.gov and search for Identifier: NCT00969969 |
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- 158 of 230 patients enrolled
- 131 patients treated - 98 Cartiva / 38 arthrodesis (2:1 randomization scheme)
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| Patient Population |
- Mean age – 57.5
- Gender – 78% Female / 22% Male
- Grade of 1st MTP OA at Baseline – 26% Grade 2 / 61% Grade 3 / 13% Grade 4
- Mean VAS Baseline Pain Score – 67
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| Projected Study Timelines |
- Last Patient Enrolled – May 2012
- Interim Study Analysis – June 2012
- Database Lock and Final Study Analysis – July 2014
- Study Results and Publications Released – August 2014
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| About the Study Sponsor |
| Carticept Medical, Inc., located in Alpharetta, Georgia, was founded in 2005 by a group of medical device industry veterans. Carticept, a private, venture capital-backed company, is dedicated to improving the quality of life for patients with osteoarthritis or cartilage damage through the development of novel therapies. |
| An estimated 27 million Americans suffer from osteoarthritis, a chronic degenerative joint disease characterized by the breakdown of the cartilage in the joint. An additional two million Americans injure the cartilage in their knees each year. Many people do not respond well to current medical treatments or are not eligible for major surgery such as a total joint replacement. Carticept's mission is to develop and market products to help physicians treat osteoarthritis and cartilage injuries and the related pain more effectively. |
| Our management team, board of directors and medical advisors are comprised of industry-recognized professionals who possess broad knowledge in orthopedics and extensive experience managing innovative medical devices from development through clinical trials, FDA approval and successful commercialization. |
