Clinical Outcomes
Overview
A total of 413 patients participated in a clinical study of the Infuse® Bone Graft/LT-Cage® Lumbar Tapered Fusion Device. The anterior open surgical approach was used for 143 patients and the anterior laparoscopic surgical approach was used for 134 patients. A group of 136 control patients were implanted with the LT-Cage Lumbar Tapered Fusion Device filled with iliac crest autograft.
The following table compares the success rates at 24 months after surgery for the 3 groups of patients:
| Anterior Open Surgical Approach Groups | ||
|---|---|---|
| Chance the investigational patients had a successful outcome | Chance the control patients had a successful outcome | |
| Fusion | 93% | 88% |
| Pain and Function | 71% | 71% |
| Neurologic Status | 81% | 82% |
| Overall Success | 57% | 57% |
| Anterior Laparoscopic Surgical Approach Groups | ||
|---|---|---|
| Chance the investigational patients had a successful outcome | Chance the control patients had a successful outcome | |
| Fusion | 93% | 88% |
| Pain and Function | 83% | 71% |
| Neurologic Status | 89% | 82% |
| Overall Success | 68% | 56.6% |
The overall success rate describes the number of patients who had successful outcomes in fusion, pain and function and neurologic status. Also, to be considered an overall success, a patient could not have a serious complication associated with the device or have a second surgery because the first surgery was not successful.
Two years after their surgery, 82% of the investigational patients and 80% of the control patients said that it was definitely true or mostly true that they were satisfied with the results of their surgery.
All the patients in the study had blood collected to see if they generated antibodies (had an allergic reaction) to specific parts of the device – rhBMP-2, bovine Type I collagen and human Type I collagen. Three patients had a response to rhBMP-2, 66 patients had a response to bovine Type I collagen and none had a response to human Type I collagen. When these results were compared to whether or not these patients had a successful outcome, no connection was seen between the antibody response and outcome.*
* Infuse® Bone Graft Package Insert premarket approval (PMA) Number P000058.
