| March 19, 2008 |
| December 12, 2008 |
| April 2008 |
| October 2008 (final data collection date for primary outcome measure) |
| The comparison between the Agilus injection and the saline control injection groups in the proportion of subjects experiencing a reduction in the assessment of pain determined by the AOS subscale for pain. [ Time Frame: At 4, 12 and 26 weeks post 3rd injection ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00642382 on ClinicalTrials.gov Archive Site |
| Secondary effectiveness parameters that will be evaluated include the following that evaluate pain, function, subject's global assessment, quality of life and an individual subject responder analysis. [ Time Frame: At 4, 12 and 26 weeks post 3rd injection ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Safety and Effectiveness of Agilus (Hyaluronic Acid) for Ankle Osteoarthritis |
| Randomized, Double Blind,Saline-Controlled, Multi-Center, Prospective Study to Evaluate the Safety and Effectiveness of Carticept's Agilus Device for the Treatment of Ankle Osteoarthritis |
The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis. |
The objective of this study is to compare the safety and effectiveness of Agilus to a saline injection (control) in the treatment of mild to moderate ankle osteoarthritis. This is a multi-center, randomized, double blind, saline controlled, prospective study with two (2) treatment groups. The active group will receive one injection of Agilus per week for three consecutive weeks for a total of three injections. The control group will receive one injection of normal saline per week for three consecutive weeks for a total of three injections. Follow up visits will occur at 4 weeks, 12 weeks and 26 weeks following the third injection. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Osteoarthritis |
- Device: Agilus
- Device: Normal saline
|
- Active Comparator: Agilus (Hyaluronic Acid)
- Placebo Comparator: Normal Saline
|
| |
| |
| Terminated |
| 17 |
| December 2008 |
| October 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 18 years or older
- Chronic, unilateral ankle pain(i.e., in only one ankle) for at least 6 months
- Diagnosis of ankle OA confirmed by radiographs (X-ray)and clinical exam
- Are normally active, without aid of mobility devices(such as crutch, walker or cane)
Exclusion Criteria:
- Have used oral steroids within 30 days (inhaled or topical steroids are acceptable)
- Have received intra-articular injections of hyaluronic acid in any joint in the last 9 months
- Have received steroid injections in any joint in last 3 months
- Have had previous surgery or arthroscopy on the affected ankle in the last 12 months
|
| Both |
| 18 Years to 95 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00642382 |
| Katie Wedbush, Carticept Medical, Inc |
| CMI-CP-Ankle-001 |
| Carticept Medical, Inc |
|
| Principal Investigator: |
Judith Baumhauer, MD |
University of Rochester |
|
|
| Carticept Medical, Inc |
| December 2008 |
