Cortoss Bone Augmentation Material - Clinical Validation
An Evaluation of the Safety and Efficacy of an Alternative Material to Polymethylmethacrylate Bone Cement for Vertebral Augmentation
The Investigational Device Exemption study that Orthovita conducted for FDA clearance of Cortoss™ Bone Augmentation Material (Cortoss) results are detailed below. This prospective, multi-center, randomized, controlled study comparing Cortoss to polymethylmethacrylate (PMMA) for the treatment of pathological vertebral fractures was performed in mostly elderly patients suffering from painful clinically diagnosed osteoporotic vertebral compression fractures (VCFs). The primary outcomes measured were VAS for pain, Oswestry Disability Index for function, maintenance of vertebral height and alignment, and absence of subsequent interventions at the study treated level(s).
Cortoss Pivotal IDE Study
|
Study Design
The Cortoss pivotal study was a multi-center,
prospective, randomized, controlled clinical
trial with a 2:1 randomization ratio of Cortoss
to PMMA patients.
Study Objective
The objective was to evaluate the safety and
effectiveness of Cortoss compared to PMMA
for vertebral augmentation using the vertebroplasty
technique.
Methods
Twenty-one sites enrolled 256 patients (162
Cortoss, 94 PMMA) with painful osteoporotic
vertebral compression fractures. Patient
outcomes were assessed by VAS, ODI,
and SF-12. Treatment success with respect to
effectiveness measures was defined as:
- Improvement of at least 20 points on VAS
and an overall VAS score of less than 50 on
a 100 point scale
- Maintenance or improvement in ODI
- Maintenance of vertebral height and
alignment
- No repeat procedures or fractures at treated
levels
|
Results
The mean values characterizing the study are provided in the following table. Data is reported at
24 months except as noted. In total 84% of Cortoss and 81% of PMMA patients completed their
24-month visit.
| Measurement |
Cortoss (n=162) |
PMMA (n=94) |
| Injection Volume |
2.3 |
3.5 |
| Combined Treatment Success (at 3 months) |
82.8% |
73.7% |
| VAS Improvement† (at 3 months) |
86.6% |
75.0% |
| ODI Maintenance† |
96.7% |
88.4% |
| Vertebral Body Height Maintenance and Alignment |
98.3% |
100% |
| SF-12 Physical Component Improvement‡ |
11.1 |
8.9 |
| SF-12 Mental Component Improvement‡ |
9.4 |
8.4 |
| Subsequent Adjacent Fractures** |
10.3% |
18.2% |
| Symptomatic Leaks |
0.9% |
0.8% |
† Indicate statistically significant differences between Cortoss and PMMA
‡ Improvement from baseline
** In patients with one level treated and no previous fracture
|
|
Conclusions
The results of this rigorous long-term study confirm those presented in the literature: vertebroplasty
is effective in the treatment of pain caused by osteoporotic vertebral compression fractures.
The data also demonstrate the statistically significant difference in early pain improvement and
long-term functional outcome; two clinically significant measures favoring Cortoss.
|