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BONE GRAFT TYPE. Bone graft material used in the. InterFuse S⢠implant was not controlled and varied among surgeons. A
FORWARD THINKING FOR THE BACK. ™
INTERFUSE S
™
SIX MONTH FUSION OUTCOMES One hundred and four consecutive patients were implanted with the InterFuse S™ interbody fusion device by five surgeons. To determine the effectiveness of the InterFuse S™, patients were followed post-operatively for six-months. Fusion and radiographic evaluations were reported by participating surgeons and an independent radiologist. At six-months after the implantation, 101 patients were found to have fused. Indications of implant subsidence, migration, implant failure, or loose posterior fixation systems were not found in conjunction with the InterFuse S™ implant.
101
101 OUT OF 104 PATIENTS IMPLANTED WITH THE INTERFUSE S™ WERE FOUND TO HAVE FUSED AT SIX-MONTHS.
PATIENTS
3 FUSED
NOT FUSED
BMP
42
BONE GRAFT TYPE
NOT REPORTED
DBM
Bone graft material used in the InterFuse S™ implant was not controlled and varied among surgeons.
SIX MONTH OUTCOMES FROM 104 CONSECUTIVE CASES HARDWARE LOOSENING
FUSION
SUBSIDENCE
MIGRATION
Number of fused patients/ Number of patients
Number of patients with subsidence/Number of patients
Number of patients with migration/Number of patients
Surgeon A
26/27
0/27
0/27
0/27
Number of patients with hardware loosening/Number of patients
Surgeon B
28/28
0/28
0/28
0/28
Surgeon C
15/16
0/16
0/16
0/16
Surgeon D
27/27
0/27
0/27
0/27
Surgeon E
5/6
0/6
0/6
0/6
Total
101/104
0/104
0/104
0/104
X-ray six months post-operative
CT scans six months post-operative
The results of this study support the design rationale that the large implant footprint of the InterFuse S™, when used in conjunction with posterior fixation, provides a stable construct for bone in-growth and spinal fusion. It also supports the proposition that the large footprint reduces the possibility of implant subsidence and migration. The large endplate-to-endplate coverage appears to reduce loading on the posterior stabilizing implants, thereby reducing the possibility of hardware loosening. These results are consistent across the broad ranges of bone graft type used in the patients.
