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Fusion or non-fusion in the painful / degenerative spineThe Asian surgeon’s view: Clinical study of application of non-fusion interspinous implants for degenerative lumbar disease
Chunde LiMD, Professor
Director, Orthopaedic Surgery DepartmentPeking University First Hospital
Beijing, China
Non fusion interspinous implants
• A very attractive alternative to spinal fusion– Especially for younger patients – Minimally invasive– Provides flexible support of the lumbar spine– Avoids adjacent segment degeneration
Biomechanics• Restores and preserves disc height • Allows shock absorption and load sharing • Preserves anatomy with minimal bone and
ligament removal • Acts to treat back pain while preserving the
mobility and anatomy of the treated segment• Allows restoration of disc height and reduction of
the load on the disc and the facets
Classification• STATIC (NONCOMPRESSIBLE) DEVICES
• X STOP (St Francis Medical, Alameda, California)• ExtenSure (NuVasive, San Diego, California)• Wallis (Abbott Spine, Austin, Texas)
• DYNAMIC (COMPRESSIBLE) DEVICES• Coflex (Paradigm Spine, New York, New York)• DIAM (Medtronic Sofamor Danek, Memphis, Tennessee)
Indication• Wallis:
– Low-back pain that accompanies degenerative lesions of grade II, III and IV (Pfirrmann MRI classification) in the following indications:
• Massive herniated disc in young adults • Recurrent herniated disc • Herniated disc accompanying an L5 sacralization transitional
anomaly• Degenerative disc disease at a segment adjacent to fusion• Degenerative lesions with or without Modic 1• Lumbar canal stenosis treated by laminotomy (not by
complete laminectomy)
Indication• Coflex
– Radiographically-confirmed moderate to severe stenosis with neural element compromise resulting in claudication and / or radicular symptoms
Indication• Coflex
– Instability (rotational or vertical) associated with recurrent herniations
– Large voluminous primary disc herniations– Adjunctive therapy for stabilizing levels above or
below a fusion (“topping-off“) in the same procedure to minimize adjacent level degeneration
Indication• Coflex
– Conjunctive therapy:• Combination with nucleus replacement• Combination with total disc replacement with mild to
moderate facet degeneration
Contra-indication• Wallis:
– Grade V degenerative lesions in the MRI classification of Pfirrmann
– Spondylolisthesis– Osteoporosis– Nonspecific low back pain– Modic 2 and Modic 3
Clinical study of application of non-fusion interspinous implants for degenerative lumbar disease at Peking University First Hospital
General Information• From September 2007 to September 2008• 68 cases with degenerative lumbar diseases
were treated with interspinous implants• Male: 39 cases• Female:29 cases• Age:26-71 yrs (average 49.3 yrs)
IndicationIndication Wallis Coflex Total
DDD 2 0 2LDH 14 15 29DLSS 9 12 21
Combined with fusion to avoid ASD 6 4 10
Combined with fusion to avoid
multiple-segment fusion
3 3 6
Total 34 34 68
MethodsThe clinical results were assessed by:– VAS of pain on lumbar and lower limbs– Lumbar JOA score – Prolo functional score
Methods• the radiological results were assessed by:
– Lumbar X ray – Dynamic X ray
• Implant positon• Segmental lodosis • Segment movement degree
– Lumbar MRI or CT • Disc nutrition • LDH recurrence
Results• 64 cases obtained complete follow-up • Follow up periods :8-18 months (average 13.6
months)Lumbar pain
VASLower limbs
pain VASLumbar JOA
scoreProlo function
scorePre-op 4.9±3.3 7.2±2.8 13.4±4.9 4.2±2.8
final follow up 1.7±1.5① 1.3±1.0① 23.5±3.1① 8.6±1.4①
① P<0.01 compared with pre-op
Segment lodosis and segment movement • Segment lodosis angles:
– 15.4±4.2°(final follow-up)– Less than 19.6±4.7° (pre-operation)
• Segment movement degree :– 10.3±4.5°(final follow-up)
Complications• No spinous process fracture• 2 cases with mild displacement of implants• 2 cases with lumbar disc herniation recurrence
and received second operation
Case2 DDD and Modic I change• Male, 32 yrs• DDD• L3/4, L4/5 Modic I change• L3/4, L4/5 interspinous fixation with Wallis
Case 5:Combined with fusion to avoid multiple-segment fusion
• Male 56 yrs– L5 Spondylolysis、Spondylolisthesis grade Ⅰ– L3-4 DLSS
• Treatment:– L5-S1 decompression and PLF– L3-4 decompression and interspinous fixation with
Wallis
Conclusion• The application of non-fusion interspinous
implants for degenerative lumbar diseases is still in the early stages
• The selection of indication is very important• Its efficacy and safety are evidenced by short
time follow-up