Two-Level No Adjacent Segment Degeneration

Success Criteria

Adjacent segment degeneration was assessed at the spinal segment immediately above and below the treated levels. An independent core lab assessed degeneration using the Kellgren-Lawrence five point grading scale.* An adjacent segment was counted as having degenerated if the segment worsened by 1 grade or more.

Results

Clinically Relevant§ Adjacent Segment Degeneration at Two-levels

Mobi-C
Fusion
 

*Note: The Kellgren-Lawrence scale looks at radiographs for evidence of disc degenerative changes, including the absence or presence of osteophytes, disc narrowing, and endplate sclerosis. The five grades are: none (0), minimal (1), definite (2), moderate (3), or severe (4).

§Note: Grades 0, I, or II were defined as not being clinically relevant, while grades III or IV were defined as clinically relevant.

One-level Adjacent Segment Degeneration

Success Criteria

Adjacent segment degeneration was assessed at the spinal segment immediately above and below the treated level. An independent core lab assessed degeneration using the Kellgren-Lawrence five point grading scale.* An adjacent segment was counted as having degenerated if the segment worsened by 1 grade or more.

Results

No Adjacent Segment Degeneration at One-level

Mobi-C
Fusion
 

*Note: The Kellgren-Lawrence scale looks at radiographs for evidence of disc degenerative changes, including the absence or presence of osteophytes, disc narrowing, and endplate sclerosis. The five grades are: none (0), minimal (1), definite (2), moderate (3), or severe (4).