Coflex TM for Lumbar Stenosis with

Transcription

1 Coflex TM for Lumbar Stenosis with Segmental Instability : 1 yr outcomes Eun-Sang Kim, M.D., Ph.D. Clinical Professor Dept of Neurosurgery Samsung Medical Center Seoul, Korea

2 Surgery for Spinal Stenosis Decompression only Develops instability Stenosis Fusion Adjacent segment failure Degenerative Spondylolisthesis II, III

3 Fusion with pedicle screws Stabilizing Effect Op time Blood loss Recovery period Adjacent segment disease through excessive stress

4 Why Interspinous Implants? Op time Blood loss Recovery period Stress on Adjacent segments (?) Stabilizing Effect without heavy metals, nor fusion (?)

5 Objective of the study Coflex TM (interspinous U ) Can it be an alternative treatment for degenerative lumbar instability?

6 Hypothesis Implanting Coflex TM would result in Similar clinical outcomes, or It may even prove superior to PLIF w/o affecting degeneration at adjacent segments.

7 Clinical Material (1) Period: Jan 00 ~ Dec 03 adults (M/F = 11/31) 18 pts: CoflexTM (by Kim) N: 42(M/F = 3/15, 61.7 yrs) 24 pts : PLIF (by Eoh) (M/F = 15/16, 56 yrs)

8 Clinical Material (2) All pts have Low back pain (LBP) Mechanical With referred pain Intermit neurog claudication Spinal stenosis w/ instability, at L4-5 level

9 Clinical Material (3) Inclusion Criteria Deg. listhesis, Gr I (18 pts) Translational slip 4 mm Angular instability (14 pts) Intervertebral ROM > 10º Mild retrolisthesis (10 pts)

10 Clinical Material (4) Exclusion Criteria Pts who have: Marked deg. listhesis > 5 mm Isthmic spondylolisthesis Lesions that need Op 2 levels

11 Demographics Coflex TM PLIF Pts. No male 3 8 female Mean age Spinal stenosis w/ angular instability 7 7 w/ translat slip 4 mm 7 11 w/ retrolisthesis 4 6

12 Methods (1) PLIF Using cages (e.g., PEEK or CH cages, etc) Additional pedicle screw fixation Autogenous iliac or lamina bone

13 Coflex TM Usual midline post. approach Skin incision, 4 cm Paravertebral m. dissection Methods (2) cranial caudal

14 Methods (3) Coflex TM Skin incision, 4 cm PVM dissection Removal of intersp. Ligament Bilat laminotomy Removal of Lig. flavum Dura

15 Coflex TM Application of template Methods (4)

16 Coflex TM Methods (5) Application of template Preparation of wingclamps

17 Coflex TM Application of template Preparation of wing-clamps Interspinous insertion of Coflex TM Methods (6)

18 Methods (7) Coflex TM Application of template. Preparation of wing-clamps Interspinous insertion of Coflex Wing-clamps tightening

19 Methods (8) Postop F/U : 1, 3, 6, &12 mos Dynamic/static radiol evaluation Segmental intervertebral angle Posterior disc height

20 Methods (9) ROM: the sum of intervertebral angle btw flexion & extension per level Flex Ext

21 Methods (10) Clinical analysis Visual Analogue Scale (VAS) Oswestry Disability Index (ODI) Wilcoxon Signed Ranks t. (SPSSx) Mann-Whitney t. for nonnumerics F/U at OPD after 1, 3, 6,&12 mo

22 RESULTS

23 Clinical Outcomes (1) No surgical complications in both PLIF and Coflex TM groups.

24 Clinical Outcomes (2) VAS ODI

25 Preop Postop Flex Ext

26 Preop Postop Flex Ext

27 Radiologic Outcome Coflex TM PLIF ROM (degree) Preop. Postop. Preop. Postop. L (±3.7) 5.7 (±3.8) 7.2 (±4.1) 10.5 * (±5.2) L (±4.1) 5.1 * (±4.8) 12.7(±3.7) 0. 7 * (±1.5) L5S1 6.6 (±4.8) 5.1 (±4.8) 11.2(±5.8) 10.2 (±7.6) PDH (mm) 7.8 (±1.8) 9.1 * (±2.2) 6.9 (±2.9) 11.2 * (±1.3) Mean value ± standard deviation. * significant statistically PDH: posterior disc height at the L4, 5 level

28 Illustrative Cases

29 Case 1. F/ 54 C/C : lower back pain & NIC (5 min)

30 Operation: Clinical course bilateral PHL with foraminotomy Coflex TM insertion VAS : 6 1 (after 6 months) ODI: NIC improved, LBP disappeared L4,5 Flexion Extension ROM Disc ht Preop Postop

31 Preop Postop Flex Ext

32 Case 2. F/ 68 C/C : lower back pain & NIC (10 min)

33 Preop Postop Flex Flex Ext Ext

34 Operation: Clinical course bilateral PHL with foraminotomy Coflex TM insertion VAS : 8 ODI : (after 5 months) NIC improved, LBP decreased L4,5 Flexion Extension ROM Disc ht Preop Postop

35 Case 3. F/ 64 C/C : LBP, NIC (200 m), Urinary incontinence

36 Preop Preop Postop 6 mo

37 Preop Postop Flex Flex Ext Ext

38 Operation: Clinical course bilateral PHL with foraminotomy interspinous U insertion VAS : 9 ODI : (after 6 months) NIC improved, LBP decreased L4,5 Flexion Extension ROM Disc ht Preop Postop

39 Summary Coflex TM Insertion at L4-5 ROM at the instrumented level No ROM change at the upper adjacent motion segment (c.f. PLIF) Mechanical LBP in lumbar stenosis with instability

40 Conclusion Coflex TM implantation can be an alternative treatment for spinal stenosis with minor segmental instability since it imparts less stress on the superior adjacent level than PLIF does.