Disc Replacement - The F.D.A. Trial
The FDA study has demonstrated that the Charite Artificial Disc is safe and effective. Its Results at 2 years follow-up are at least as good as an anterior fusion with however several important advantages. Fifteen centers in the US participated. Fabien Bitan was the principal investigator for the Northeast of the country.
The patients were randomized (Randomly assigned to either a Disc Replacement or a fusion) with a ratio of 2 (disc) to 1 (fusion). In each center the first 5 patients were not randomized ("training cases"). The total number of patients was 366, 75 trainings, 194 Charites randomized, 97 Fusions randomized. The study was limited to skeletally mature patients with single level degenerative disc disease. The results were evaluated after the patients have been followed for 2 years according to a strict protocol. Overall, the Charite and the anterior fusion using a cage (BAK) have similar adverse event profiles. However the artificial disc group showed less additional surgeries at the operated level for complications and less device failures. Moreover, obviously the ADR group did not present the complications specific to fusions (Failure of fusion for example).
The functional results showed that the Charite Artificial Disc is at least equivalent to the fusion for one level Degenerative Disc Disease. In fact, the success rate for the Charite was showed superior in several areas. Patients' satisfaction surveys showed a significant superiority of the Charite group over the BAK fusion group. This finding at 1 year follow-up was even more obvious at 2 years.
Radiographic findings confirm the investigators' expectations. The range of motion at the operated level was near physiologic. Five cases of device displacement were observed.
In conclusion, the FDA trial showed the advantages of Charite Artificial Disc over anterior fusion.
- Superior clinical improvement (Function, Pain, Quality of life)
- Shorter hospitalization
- Higher patient satisfaction
On the radiological standpoint:
- Better disc height
- Better range of motion
These results were maintained after 2 years
Patients will continue to be followed in order to obtain long-term follow-up.
The clinical Investigators who performed the procedures for the FDA trial are:
|Robert Banco, MD Boston, MA|
|Fabien Bitan,MD New York, NY|
|Scott Blumenthal, MD Dallas, TX|
|Andy Cappuccino, MD Lockport, NY|
|Rolando Garcia, MD Aventura, FL|
|Fred Geisler, MD Chicago, IL|
|Richard Holt, MD Louisville, KY|
|Jorge Isaza, MD Baton Rouge, LA|
|James Maxwell, MD Scottsdale, AZ|
|Paul McAfee, MD Townson, MD|
|Michael McNamara, MD Franklin, TN|
|Bradford Mullin, MD Columbus OH|
|John Regan, MD Los Angeles, CA|
|Robert Watkins, MD Los Angeles, CA|
|Doug Wong, MD Golden, CO||