Clinical Trial Design
The PROGRESS IV clinical trial will randomly assign patients to receive either a single injection of autologous protein solution?OR?saline. To participate in the trial, patients must have early to moderate symptomatic OA in one knee and have failed at least one prior conservative OA therapy.
Participation will require at least six doctor’s office visits over a maximum period of 16 months. The schedule of visits is as follows:
- Screening visit (includes an X-Ray and MRI)
- Injection visit (within 28 days of screening)
- Follow-up visit one month after injection
- Follow-up visit three months after injection?
- Follow-up visit six months after injection?
- Follow-up visit 12 months after injection (includes an X-Ray and MRI to assess anatomical changes)
After the 12 month visit, patients may choose to receive an injection of APS. If you do choose to receive another injection, you will have two additional visits:
- Second injection visit
- Second injection follow-up visit one month after second injection
Patients should not enroll in the trial unless they are willing and able to honor the time commitment outlined above.