2. One-year follow up of a prospective case control study of 60 patients
Does an interspinous device (CoflexTM) improve the outcome of decompressive surgery in lumbar spinal stenosis?
One-year follow up of a prospective case control study of 60 patients By
Tariq E. Awad
Lecturer of Neurosurgery
Suez Canal University

11. Introduction and Rationale
LSS due to degenerative changes is
a disabling disease common in the elderly.
Decompressive surgery was shown to be a successful in relieving symptoms of LSS & being superior to conservative treatment in long-term examinations .
No clear evidence about the most effective technique of decompression or the extend of that decompression.
Interspinous-based dynamic stabilization after decompression is currently being investigated as a good additional procedure which might improve the clinical outcome.

12. Device Information CoflexTM device is one of the dynamic
interspinous implants (Paradigm Spine,
LCC, New York, NY), formerly Interspinous ‘U’.
It is a compressible U-shaped titan device
It is interposed between the spinous process after decompressive surgery.
First invented in 1994 by the French orthopaedic surgeon Jacques Samani as an alternative to arthrodesis, to protect adjacent levels after spinal surgery & for the protection of degenerative segments following decompressive surgery.

13. Aim of implanting Coflex interspinous devices
Unload the facet joints.
Restore foraminal height.
Dynamic provide stability especially in extension but still allow motion in the treated segment
stop the progressive course of degenerative disc disease and foster the healing of the least severe lesions.

14. Aim of implanting Coflex interspinous devices
In vitro studies have demonstrated a reduction in facet joint forces by 68% and annulus pressures by 63%. (Swanson et al 2005)
This procedure is fully reversible, leaving all subsequent surgical options open including disc replacement, full laminectomy and fusion.

15. Aim of the Work
To evaluate the surgical outcomes of decompressive surgery in comparison to decompressive surgery & additional implantation of the CoflexTM interspinous Device to assess safety & efficacy of the implant.

16. Clinical Materials, Patients and Methods
Study Design:
A prospective controlled, non randomized, clinical trial
Patient Population
Between May 2008 and April 2010,
At Suez Canal University Hospital (Ismailia, Egypt)
60 patients indicated for decompressive surgery were included in this study.
Patients were categorized into 2 groups ( each had 30 patients):
A) Group 1: undercutting-group (UC)
B) Group 2: Coflex-Group (CO)

17. Methods

18. Surgical procedure

19. Results
Distribution of the treated level in the Coflex-group & the undercutting –group.

20. Results
ODI preoperatively & at each follow up in the 2 groups. All follow up scores are significant improved (p<0.001) compared to base line with no significant difference

21. Results VAS preoperatively and at each follow
up in the two treatment groups. All follow up scores are significant improved (p<0.001) compared to base line with no significant difference
Walking distance over time. All patients had a significant prolonged walking distance (p<0.001) with no significant main difference between the operation method was found.

22. Results
Subjective satisfaction and subjective operation decision.

23. Case Examples
55 ys M
c/o NC for 6 months WD 100 m

25. Conclusion
After decompressive surgery for lumbar spinal stenosis, all measured parameters improved significantly (p<0.001) compared to base line, independent of the operation method.
The additional placement of a CoflexTM interspinous device seems to be a safe procedure but did not improve the clinical outcome at the 12-month follow up interval.
No difference in the patient satisfaction & the subjective operative decision was noted between the groups treated with or without CoflexTM implant.

26. Conclusion
This study has a limitation in the short- term follow up period of 12 month, the missing randomization and the number of patient being included.
While there is no current evidence of the efficacy of the Coflex device, we have to collect more data in a longer follow up

27. Thanks