Treatment of Lumbo-sacral steno-instability ( esperienza col sistema interspinoso BacJac)

Treatment of Lumbo-sacral Treatment of Lumbo-sacral steno-instabilitysteno-instability

((esperienza col sistema esperienza col sistema interspinoso BacJac)interspinoso BacJac)

Dott. RAFFAELE MANGIALARDIDott. RAFFAELE MANGIALARDI

[email protected] (CBH Bari - S. Camillo Taranto) (CBH Bari - S. Camillo Taranto)

mailto:[email protected]

It is a pathological narrowing of the neural It is a pathological narrowing of the neural

channel and/ or the conjugation foramen channel and/ or the conjugation foramen

(caused by bone, arthrosis, and joint (caused by bone, arthrosis, and joint

changes with:changes with:

VERTEBRAL STENOSISVERTEBRAL STENOSIS

COMPRESSION COMPRESSION OF THE NERVOUS OF THE NERVOUS STRUCTURES.STRUCTURES.

Two biomechanical types of Two biomechanical types of stenosis:stenosis:

--Dynamic stenosisDynamic stenosis (manifests itself (manifests itself at spine movements)at spine movements)

--Fixed stenosisFixed stenosis (in advanced (in advanced stage)stage)

DYNAMIC STENOSISDYNAMIC STENOSIS

INSTABILITY PHASE with INSTABILITY PHASE with SPINAL FIXED STENOSISSPINAL FIXED STENOSIS

As the degeneration As the degeneration progresses, it becomes a progresses, it becomes a fixed stenosis fixed stenosis. .

The dimensions of the The dimensions of the central and lateral central and lateral channels reduce because channels reduce because of facet hypertrophy, of facet hypertrophy, thickening of yellow thickening of yellow ligaments with their ligaments with their bulging in the channel.bulging in the channel.

MECHANICAL PRESSURE on the MECHANICAL PRESSURE on the SPINAL NEUROSTENOSIS SPINAL NEUROSTENOSIS

STRUCTURESSTRUCTURES

MECHANICAL PRESSURE on the MECHANICAL PRESSURE on the SPINAL NEUROSTENOSIS SPINAL NEUROSTENOSIS

STRUCTURESSTRUCTURESMechanical irritationMechanical irritation

(traction (traction compression)compression)

Chemical irritationChemical irritation

(nucleus)(nucleus)

Intra-neural inflammationIntra-neural inflammation

(ischemia, edema, demyelinization)(ischemia, edema, demyelinization)

Functional alterationsFunctional alterations

Lost nervous functionLost nervous function Hyperexcitability (pain)Hyperexcitability (pain)

(generation of ectopic (generation of ectopic impulses)impulses)

Establishing of causes and areas of the Establishing of causes and areas of the DEGENERATIVE STENOSISDEGENERATIVE STENOSIS

NoNo

We should considerWe should consider further anatomic further anatomic pathological conditions!!!pathological conditions!!!

……Clinical recovery becomes Clinical recovery becomes impossibleimpossible..

Advanced degenerative changesAdvanced degenerative changes

Severe degenerative disc disease at L5-S1

Severe STENOSISSevere STENOSIS

Stenosis at L4-5Stenosis at L4-5


Impact of stenosis on nervous and vascular structures

TREATMENT OPTIONSTREATMENT OPTIONSDEPENDING ON THE CASE:DEPENDING ON THE CASE:

1)1) Conservative treatmentConservative treatment2)2) ““Major”Major” SURGICAL TREATMENT SURGICAL TREATMENT

Between the twoBetween the two: Use of: Use of

INTERSPINOUS IMPLANTSINTERSPINOUS IMPLANTS

CONSERVATIVE TREATMENTSCONSERVATIVE TREATMENTS

Peri-epidural infiltrationsPeri-epidural infiltrations

NSAIDNSAID

CalcitoninCalcitonin

Long-term bed restLong-term bed rest

Physical therapy (Magnetotherapy, Ionophoresis, TENS, Physical therapy (Magnetotherapy, Ionophoresis, TENS, etc) etc)

Kineti therapy(postural training, swimming, etc..)Kineti therapy(postural training, swimming, etc..)

Corseta and orthosesCorseta and orthoses

““Major” surgical treatmentsMajor” surgical treatments

Laminectomy or LaminotomyLaminectomy or Laminotomy

Laminectomy and/ or foraminotomyLaminectomy and/ or foraminotomy

Laminectomy + foraminotomy Laminectomy + foraminotomy completed by partial arthrectomy plus completed by partial arthrectomy plus fusion (in case of severe instability) fusion (in case of severe instability) with intersomatic arthrodesis (screws, with intersomatic arthrodesis (screws, plates)plates)

Difference between interspinous Difference between interspinous surgery versus laminectomysurgery versus laminectomy

IncisionIncision 4-6 cm4-6 cm

SurgerySurgery above the laminaabove the lamina

EBLEBL 0 cc0 cc

Surgery timeSurgery time 40-60 min40-60 min

ComplicationsComplications 3,3 %3,3 %

Patient is soon able to standPatient is soon able to stand

Return to activityReturn to activity 7-10 days7-10 days

Patient favors this treatmentPatient favors this treatment

10-13 cm10-13 cm

under the laminaunder the lamina

few, but presentfew, but present

120-150 min120-150 min

9,7 %9,7 %

bed rest: minimum 2-3 daysbed rest: minimum 2-3 days

after approximately 30 daysafter approximately 30 days

Patient does not favor this treatmentPatient does not favor this treatment

Why an interspinous Why an interspinous intervention is performedintervention is performed

The idea of a The idea of a device positioned between the device positioned between the spinous processesspinous processes in order to improve in order to improve symptomatology of the lumbar stenosis, it stems symptomatology of the lumbar stenosis, it stems out of a simple clinical observation:out of a simple clinical observation:The patients’ symptoms improve while flexion of The patients’ symptoms improve while flexion of the spine and they become worse while they the spine and they become worse while they hyperextend it:hyperextend it:

This is where comes the idea of an implant, This is where comes the idea of an implant, which would limit the extension, at the same which would limit the extension, at the same time restricting the channel and lateral time restricting the channel and lateral formamina, to be inserted duringformamina, to be inserted during

a mini-invasive intervention.a mini-invasive intervention.

Why IWhy Interspinous Decompressionnterspinous Decompression

CLINICAL MOTIVATIONSCLINICAL MOTIVATIONS

The symptoms worsen at spine The symptoms worsen at spine extension and subside in flexion.extension and subside in flexion.

The patients are feeling better while The patients are feeling better while seated with upper limbs on a table in seated with upper limbs on a table in orthostatic position in slight flexionorthostatic position in slight flexion

Biomechanical studiesBiomechanical studies confirm the effect: confirm the effect:

•The in situ load on spinous processes is only The in situ load on spinous processes is only 12 – 16%12 – 16%

•The implant, inserted into the interspinous The implant, inserted into the interspinous space, remains very stable.space, remains very stable.


ANATOMICAL MOTIVATIONANATOMICAL MOTIVATION

The following happens during extension The following happens during extension of the spine:of the spine:

1)1) Worsening of the bulging discWorsening of the bulging disc

2)2) Worsening of the recess stenosisWorsening of the recess stenosis

3)3) Worsening of the minimal listhesisWorsening of the minimal listhesis

4)4) Worsening of local lack of stabilityWorsening of local lack of stability


Dynamic TestsDynamic Tests

Revealed that the interspinous deviceRevealed that the interspinous device

Limits extension of the affected area and does Limits extension of the affected area and does not limit the axial rotation and the lateral not limit the axial rotation and the lateral movement of the spine.movement of the spine.


Studies of the therapeutic mechanism Studies of the therapeutic mechanism revealed that:revealed that:

– In extensionIn extension, , the channel area, its the channel area, its diameter and sub-joint diameter diameter and sub-joint diameter increased by: 18%,10%,48%increased by: 18%,10%,48%

– The foraminal area and the linear The foraminal area and the linear surfcasurfca increased, respectively, by increased, respectively, by 25% and 41%25% and 41%


Pressure on the disc and load on the facet Pressure on the disc and load on the facet joints diminish at the treated level.joints diminish at the treated level.

In extension, the pressure on the posterior In extension, the pressure on the posterior part of the anulus diminish by 63%part of the anulus diminish by 63%

The pressure in the nucleus diminishes by The pressure in the nucleus diminishes by 41%41%

The pressure on the facet diminishes by 58%The pressure on the facet diminishes by 58%

There are no pressure changes in the levels There are no pressure changes in the levels adjacent to the treated one.adjacent to the treated one.


PATHOLOGIES TREATABLE with PATHOLOGIES TREATABLE with interspinous devicesinterspinous devices

• Lumbar spinal stenosisLumbar spinal stenosis• Degenerative spondylolisthesis (up to Grade I)Degenerative spondylolisthesis (up to Grade I)• Baastrups’ syndromeBaastrups’ syndrome• Disc degeneration (also post-operative)Disc degeneration (also post-operative)• Instability and facet syndromesInstability and facet syndromes• Modic I degeneration, associated with stenosisModic I degeneration, associated with stenosis• Disc protrusion, associated with stenosis and recess Disc protrusion, associated with stenosis and recess

stenosisstenosis• Lumbar pain induced by axial loadLumbar pain induced by axial load• Disc unloading, adjacent to the arthrodesis siteDisc unloading, adjacent to the arthrodesis site• Post-discectomy disc assistancePost-discectomy disc assistance• Internal lesion of the discInternal lesion of the disc

CONTRAINDICATIONSCONTRAINDICATIONSScoliosis greater than 25° (Cobb)Scoliosis greater than 25° (Cobb)Cauda equina syndromeCauda equina syndromeIsthmic spondylolisthesisIsthmic spondylolisthesisPthological or multiple vertebral fracturesPthological or multiple vertebral fracturesSevere obesitasSevere obesitasPaget disaese or vertebral metastasesPaget disaese or vertebral metastasesActive infectionActive infectionAnatomic conditions that do not allow for a Anatomic conditions that do not allow for a stable implantation of the device.stable implantation of the device.

New interspinous approachNew interspinous approach

The B A C J A CThe B A C J A C

Following test using other Following test using other interspinous devices, which interspinous devices, which are still ongoing, we started are still ongoing, we started using the BacJac.using the BacJac.

The BacJacThe BacJac

KINEMATICS OF BACJACKINEMATICS OF BACJAC

Reduces the extension of the treated Reduces the extension of the treated are in flexion-extensionare in flexion-extension

Maintains the range of motion in Maintains the range of motion in rotation and lateral bendingrotation and lateral bending

Does not have any impact on the range Does not have any impact on the range of motion of the adjacent segments.of motion of the adjacent segments.

Indications for BacJac Indications for BacJac

Intermittent neurogenic claudication (INC)Intermittent neurogenic claudication (INC)

Spondylolisthesis up to grade 1.5 (out of 4, Spondylolisthesis up to grade 1.5 (out of 4, approximately 35%) with INCapproximately 35%) with INC

Baastrup syndrome/ Disc loweringBaastrup syndrome/ Disc lowering

Back pain caused by axial loadBack pain caused by axial load

Facet syndromeFacet syndrome

Degenerative and/ or iatrogenic disc syndromeDegenerative and/ or iatrogenic disc syndrome

Contained herniation of the nucleusContained herniation of the nucleus

Shift of disc adjacent to lumbar arthrodesisShift of disc adjacent to lumbar arthrodesis

BacJac impact on the canal BacJac impact on the canal dimensionsdimensions

In extension, it decompresses the nervous In extension, it decompresses the nervous structures at the treated level, increasingstructures at the treated level, increasingSpinal canal area by 18%;Spinal canal area by 18%;Diameter of the spinal canal by9%;Diameter of the spinal canal by9%;Sub-articular diameter by 50%;Sub-articular diameter by 50%;Foraminal area by 25%;Foraminal area by 25%;Foramen width by 41%.Foramen width by 41%.

There is no impact on the adjacent levels.There is no impact on the adjacent levels.

BacJac : Action on the disc BacJac : Action on the disc pressurepressure

In extension, it reduces the pressure of In extension, it reduces the pressure of the posterior anulus by 63% and of the the posterior anulus by 63% and of the nucleus by 41%nucleus by 41%

Does not increase pressure on the Does not increase pressure on the adjacent discs.adjacent discs.

BacJac: Impact on the disc heightBacJac: Impact on the disc height

It increase the posterior height of It increase the posterior height of the vertebral discthe vertebral disc

(at the level of the implant)(at the level of the implant)

by 1,5 mmby 1,5 mm

BacJac: Pressure on the BacJac: Pressure on the adjacent facetadjacent facet

In extension, at the implant level, it In extension, at the implant level, it reduces the pressure on the articular reduces the pressure on the articular

facets by 61%.facets by 61%.

It does not increase the pressure on the It does not increase the pressure on the facet of the adjacent segments.facet of the adjacent segments.

BacJac: sagittal balanceBacJac: sagittal balance

In neutral position, implants at 1 level In neutral position, implants at 1 level or 2 levels, do not change the lumbar or 2 levels, do not change the lumbar

curvature, considering the initial curvature, considering the initial pathological curve.pathological curve.

Indications/ contraindications for Indications/ contraindications for BacJacBacJac

Indications:Indications:– Motor deficitMotor deficit– Lumbar instabilityLumbar instability– Previous spine Previous spine

surgerysurgery

Contraindications:Contraindications:– Major low back Major low back

painpain– Symptoms that Symptoms that

increase in flexionincrease in flexion

Surgery detailsSurgery detailsVertical incision of 3 m, at 1 cm from the Vertical incision of 3 m, at 1 cm from the median line.median line.

No supraspinal ligament damage.No supraspinal ligament damage.

At BacJac insertion, remove any anatomic At BacJac insertion, remove any anatomic obstacles (such as hypertrophic facets).obstacles (such as hypertrophic facets).

BacJac instrumentsBacJac instruments

Small dilator (5 mm)Small dilator (5 mm)Big dilator (8 mm)Big dilator (8 mm)Interspinous divaricator and sizerInterspinous divaricator and sizerBacJac inserter with pusherBacJac inserter with pusherRemoval toolRemoval tool

BacJac characteristicsBacJac characteristics

Load resistantLoad resistantBiocompatibilityBiocompatibilityNo MRI and CT artifactsNo MRI and CT artifactsLarge contact areaLarge contact areaMinimal risk of dislocationMinimal risk of dislocationBiomechanical modules similar to physiological Biomechanical modules similar to physiological onesones

BacJac characteristicsBacJac characteristics

Unilateral approachUnilateral approachPreservation of ligamentsPreservation of ligamentsMinimal invasiveMinimal invasiveIt “positions itself” suring insertionIt “positions itself” suring insertion

Surgical Technique(BacJac)Surgical Technique(BacJac)

Lateral or knee-pectoral decubitusLateral or knee-pectoral decubitus

Adjusts to the space (lateral X-ray)Adjusts to the space (lateral X-ray)

General, local or peridural anaesthesiaGeneral, local or peridural anaesthesia

Median incision of approximately 3 – 5 cmMedian incision of approximately 3 – 5 cm

Partial exposure of the lamina, only on one side, exposure of Partial exposure of the lamina, only on one side, exposure of interspinous ligament.interspinous ligament.

Perforate the interspinous ligament, leaving intact the supraspinal Perforate the interspinous ligament, leaving intact the supraspinal ligament (this way avoiding any possible dislocation of the prosthesis)ligament (this way avoiding any possible dislocation of the prosthesis)

Post operativePost operativeEach surgeon follows his own post-op routines, Each surgeon follows his own post-op routines, based on age and general conditions.based on age and general conditions.Generally: Generally: The patient returns to his activities The patient returns to his activities WHEN HE CAN TOLERATE THEM.WHEN HE CAN TOLERATE THEM.For 6 weeks: Do not lift weights.For 6 weeks: Do not lift weights.After 20 days: Muscle strengthening exercises, After 20 days: Muscle strengthening exercises, if tolerated.if tolerated.

Personal casesPersonal cases

Usage of inclusion and exclusion criteria.Usage of inclusion and exclusion criteria.Clinical examination.Clinical examination.Instrument-assisted examinations: X-Rays Instrument-assisted examinations: X-Rays (standard and dynamic)MRI, CT, EMG.(standard and dynamic)MRI, CT, EMG.

Clinical study: Clinical study: Inclusion criteriaInclusion criteria

Clinical and radiological inclusion criteria:Clinical and radiological inclusion criteria:

Patients with pain in the lower limbs, gluteus, inguinal pain, Patients with pain in the lower limbs, gluteus, inguinal pain, with or without lumbar pain.with or without lumbar pain.

In order to qualify for the study, the patients must be able to sit In order to qualify for the study, the patients must be able to sit for 50 minutes without pain, walk for 50 minutes without pain, for 50 minutes without pain, walk for 50 minutes without pain, and have followed conservative treatment for six months.and have followed conservative treatment for six months.

The diagnosis of spinal stenosis (LSS) or lateral stenosis must be The diagnosis of spinal stenosis (LSS) or lateral stenosis must be confirmed using CT or MRI at 1 or 2 levels.confirmed using CT or MRI at 1 or 2 levels.

Clinical Study: Clinical Study: Exclusion CriteriaExclusion Criteria

Clinical and radiological exclusion criteria:Clinical and radiological exclusion criteria:

Permanent neurological deficitPermanent neurological deficit

Cauda equina syndromeCauda equina syndrome

Major lumbar instability following a previous surgical interventionMajor lumbar instability following a previous surgical intervention

Major peripheral neuropathy or acute secondary and radicular enervationMajor peripheral neuropathy or acute secondary and radicular enervation

Spondylolisthesis at more than 1.5Spondylolisthesis at more than 1.5 (on a scel from 1 to 4) (on a scel from 1 to 4)

Systemic infectionsSystemic infections

Paget diseasePaget disease

Contraindiations BacJacContraindiations BacJac

Constant pain, not related to the dorsal spine positionConstant pain, not related to the dorsal spine position

Cauda equina syndrome caused by neural compression, which causes Cauda equina syndrome caused by neural compression, which causes neurogenic intestinal dysfunction (fecal incontinence) or neurogenic urinary neurogenic intestinal dysfunction (fecal incontinence) or neurogenic urinary dysfunction (urinary retention or incontinence)dysfunction (urinary retention or incontinence)

Major scoliosis(Cobb angle of more than 25°)Major scoliosis(Cobb angle of more than 25°)

Isthmic or degenerative spondylolisthesis at the level exceeding 1.5 (on a scale Isthmic or degenerative spondylolisthesis at the level exceeding 1.5 (on a scale from 1 to 4) at the affected levelfrom 1 to 4) at the affected level

Pathological or multiple fractures of vertebra and/ or hipsPathological or multiple fractures of vertebra and/ or hips

Obesity (with the body mass index exceeding 40 kg/ mObesity (with the body mass index exceeding 40 kg/ m22););

Paget disease of the affected segment or vertebral metastasesPaget disease of the affected segment or vertebral metastases

Active infectionActive infection

Abnormal spinal anatomy, which would prevent from implanting of the Abnormal spinal anatomy, which would prevent from implanting of the device, or anatomy that would cause lack of implant’s stability follwoing device, or anatomy that would cause lack of implant’s stability follwoing the implantthe implant

Contraindications BacJacContraindications BacJac

Personal casesPersonal casesAverage age:Average age: 58 years58 yearsLevels:Levels: L2-3, L3-4, L4-5, L5-S1L2-3, L3-4, L4-5, L5-S1Pathologies:Pathologies: steno-instability, facet stenosissteno-instability, facet stenosisSingle level:Single level: 60 % of cases60 % of casesDouble level: 40 % of casesDouble level: 40 % of cases

Implants (status October 2008): 60Implants (status October 2008): 60

Pre-op MRI: Stenosis, especially at L4-5Pre-op MRI: Stenosis, especially at L4-5

Post-op X-ray with 2 BacJacsPost-op X-ray with 2 BacJacs

ResultsResults

70%70% : : Improvementas of the first post-op day (the Improvementas of the first post-op day (the patients can even sleep in prone position, patients can even sleep in prone position, increased walking autonomy, etc).increased walking autonomy, etc).

2020%:%: Partial, but fast improvementsPartial, but fast improvements** As of now: As of now: no patient underwent subsequent no patient underwent subsequent

surgerysurgery (in order to repair the supraspinal (in order to repair the supraspinal ligament or for posterior dislocation of BacJac, or ligament or for posterior dislocation of BacJac, or for a subsequent decompression laminectomy).for a subsequent decompression laminectomy).

10%:10%: There is no improvement, but no subsequent There is no improvement, but no subsequent surgeries either.surgeries either.

ResultsResults

All patients could stand the day following the All patients could stand the day following the surgery (and in 25 cases, the evening of the surgery (and in 25 cases, the evening of the surgery).surgery).Most of the patients (following a control X-ray of Most of the patients (following a control X-ray of the L-S spine in orthostatic position with AP and LL the L-S spine in orthostatic position with AP and LL projections) were dsicharged home before the projections) were dsicharged home before the scheduled time (maximal stay: 3 days).scheduled time (maximal stay: 3 days).

““Minimal” surgical intervention, which is simple and efficient, indicated Minimal” surgical intervention, which is simple and efficient, indicated for patient suffering from claudication secondary to the lumbar canal for patient suffering from claudication secondary to the lumbar canal and/ or conjugation foraminal stenosis.and/ or conjugation foraminal stenosis.

Valid alternative to the traditional surgical treatment.Valid alternative to the traditional surgical treatment.

Preserves the anatomical structures.Preserves the anatomical structures.

Does not change the situation of the metamers above and below the Does not change the situation of the metamers above and below the treated area.treated area.

CONCLUSIONS REGARDING THE USE OF BACJAC

CONCLUSIONS REGARDING THE USE OF CONCLUSIONS REGARDING THE USE OF BACJACBACJAC

It is a rigid interspinous device, which limits extension of the spine.It is a rigid interspinous device, which limits extension of the spine.

It does not limit the axial rotation and antero-lateral flexion.It does not limit the axial rotation and antero-lateral flexion.

It decreases the pressure on the disc and the articular facet and It decreases the pressure on the disc and the articular facet and increase the foramina at the affected area.increase the foramina at the affected area.

The insertion of the device does not modify the conditions at the The insertion of the device does not modify the conditions at the adjacent metamers, located above and below.adjacent metamers, located above and below.

Please do not Please do not hesitate to hesitate to contact us for contact us for further further informationinformation

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Treatment of Lumbo-sacral steno-instability ( esperienza col sistema interspinoso BacJac)

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