Two-level Range of Motion (ROM)

Success Criteria

Mobi-C Required ROM ≥2° in flexion/extension (F/E) at the index levels and lack of bridging bone
Fusion Required development of bridging bone, <2° of angular motion at the index levels, and absence of radiolucent lines

Results

Randomized Mobi-C subjects demonstrated mean ROM at the inferior index level of 8.4° for flexion-extension and 5.1° for lateral bending. At the superior index level, Mobi-C subjects demonstrated mean ROM of 10.1° for flexion-extension and 5.6° for lateral bending.

Two-level ROM at Inferior Index Level

Mobi-C Mean F/E
 
Mobi-C Mean Lateral Bend
 

Two-Level ROM at Superior Index Level

Mobi-C Mean F/E
 
Mobi-C Mean Lateral Bend
 

*Note: Percent of randomized subjects with available data.

Fusion Status
Investigational Device Exemption (IDE) Study
6M 42/94
(44.7%)
12M 61/94
(64.9%)
24M 79/99
(79.8%)
36M 72/83
(86.7%)
48M 68/80
(85.0%)
Post Approval Study (PAS)
60M 68/79
(86.1%)

One-level Range of Motion (ROM)

Success Criteria

Mobi-C Required ROM ≥2° in flexion/extension (F/E) at the index levels and lack of bridging bone
Fusion Required development of bridging bone, <2° of angular motion at the index level, and absence of radiolucent lines

Results

Randomized Mobi-C subjects demonstrated mean ROM at the index level of 10.3° for flexion-extension and 5.5° for lateral bending. 

One-level ROM at Index Level

Mobi-C Mean F/E
 
Mobi-C Mean Lateral Bend
 

*Note: Percent of randomized subjects with available data.

Fusion Status
Investigational Device Exemption (IDE) Study
6M 42/69
(60.9%)
12M 57/69
(82.7%)
24M 67/75
(89.3%)
36M 56/62
(90.3%)
48M 57/61
(93.4%)
Post Approval Study (PAS)
60M 56/60
(93.3%)