Experiencia de Estudio de Casos con iFuse

Carlton Reckling, MD

El Dr. W. Carlton Reckling es el Vicepresidente de Asuntos Médicos de SI-BONE. El Dr. Reckling es un cirujano ortopédico de columna certificado con más de 17 años de experiencia en cirugía de columna e investigación clínica en Cheyenne, WY, Ft. Collins, CO, y St. Paul, MN.  Su experiencia incluye la autoría de numerosas publicaciones sobre ortopedia clínica, presentaciones en la sociedad de cirugía ortopédica sobre una amplia variedad de procedimientos y técnicas espinales, prácticas activas en cirugía espinal ortopédica en diferentes estados con licencias en MN, WY, CO y NB, la membresía activa en diversas sociedades de cirugía espinal ortopédica, incluida la North American Spine Society (NASS) y la American Association of Orthopedic Surgery (AAOS) y la consultoría académica para compañías de tecnología para dispositivos médicos. En este video, el Dr. Reclikng comparte su experiencia personal con el iFuse Implant System.

El iFuse Implant System está previsto para la fusión sacroilíaca en afecciones como la disfunción de la articulación sacroilíaca, que es resultado directo de la desalineación de la articulación sacroilíaca y de la sacroileítis degenerativa. Se incluyen afecciones cuyos síntomas comenzaron durante el embarazo o en el periodo periparto y han persistido después del parto durante más de 6 meses. Existen riesgos potenciales asociados con el iFuse Implant System. Es posible que no sea adecuado para todos los pacientes y es posible que no todos los pacientes se beneficien. Para obtener información sobre los riesgos, visite: www.es.si-bone.com/riesgos

"Hello, I’m Dr. Carlton Reckling, Vice President of Medical Affairs for SI Bone.  I have 17 years experience as an orthopedic spine surgeon.  I did a spine fellowship in Nottingham, England.  In Nottingham, we did our own injections.  In Nottingham, I became more comfortable with the diagnosis and treatment of sacroiliac joint pathology.  And during the years in private practice in Cheyenne, Wyoming and Ft. Collins, Colorado, I did a fair number of open SI joint fusions.  I’m a member of NAAS and AAOS.  I currently hold the position of Vice President of Medical Affairs for SI-Bone.

I do have extensive experience performing the iFuse procedure.  During a little over a two-year period, January, 2010 to April, 2012, I performed 70 iFuse procedures on 55 different patients.  The age range was 18 to 80.  There was a female dominance 2-to-1 over male.  I did have two complications which required re-operation.  One of my implants was a little bit medial into the neuroforamen.  The next day, I just backed that out a couple of millimeters and she was fine.

One other patient I placed the implant a bit too distally and that caused some numbness and pain down the patient’s leg.  I just removed that implant six days after surgery.  She went on to do well and ultimately had the opposite side fused as well.  I had two patients early in my series with post-operative hematoma.  I believe that I improved my soft tissue management and surgical technique because of that and had no further problems.  I had no infections in my series.  And, in fact, infection is very rare in this type of surgery.
Assessing the patients as to outcome at their most recent visit, ranging anywhere from six months to two years asking the patients the question would you have the procedure again?  51 of 55 answered affirmatively.  

That’s 92%.  In terms of diagnosis, the majority of these patients had degenerative sacroilitis.  That’s the number on the top, 51 of the 55.  Four the patients had SI joint disruption.  Of the patients with degenerative sacroilitis, 30 were secondary to adjacent segment disease after prior lumbar fusion.  16 as a result of trauma.  Three from scoliosis or anatomic anomaly, if you would.  One was post infection and one had significant degenerative change, secondary to rheumatoid arthritis.

Several of the patients ended up having bilateral surgery.  You saw that 15 of the patients had returned during my follow up period to have the opposite site fused.  14 of those 15 were fused on the opposite side, averaging three months after the first side was fused.  One patient was performed at the same surgical setting.  Two patients had had prior open fusion on the contralateral side.  And in summary, 15 of the 17 had had prior lumbar fusion.  And in my mind, this speaks to the fact that if it’s an adjacent segment problem, it’s more likely to be bilateral.  As is the case, 15 out of 17 had had prior lumbar fusion.
I do have a case example that I would like to share with you.  Anyone who has been practicing spine surgery in the same location for several years would have a patient like this in their office.  This patient was 51 when I saw her back in 1999.  She was involved in a motor vehicle accident at which time she was T-boned on the driver’s side.  She was complaining of back and right leg pain.  She was neurologically intact.  Patrick’s was positive.  So even in 1999, my clinic’s note says her Patrick’s test was positive.

I treated her non-surgically with physical therapy, epidurals, medications, chiropractic treatment.  She failed to improve.  MRI scan showed disc damage, disc bulge and annular tears at the 4-5 and 5-1 levels.  Discograms were positive for concordant pain reproduction at 4-5 and 5-1.  Negative for concordant pain reproduction at 3-4.  In May, 2000, I performed an anterior-posterior fusion L4 to the sacrum with femoral ring allographed anteriorly and posterior instrumentation with a iliac crest graphed posteriorly.  After her lumbar surgery, she stated she had much less back pain, but she was still complaining of right buttock and right posterior thigh pain.  She did have an SI injection, which gave her some modest relief.  She ended up in pain management.

I wanna share this MRI scan which was obtained by the paint management physician four years post-op because it shows that the L3-L4 disc very well maintained.  No loss of height, well maintained signal integrity.  No canal compromise.  She was having ongoing low back, buttock and posterior thigh pain, but the 3-4 disc looks good.  She was still receiving injections to the crest site, the trochanteric bursa and the right SI joint.
She came back to see me in 2008.  I hadn’t seen her for several years.  She grabbed me by the lapels and said “Doc, I can’t stand this.  I have bilateral pain no, right side worse than left.  It’s in the back, buttock, hip, groin, posterior thigh.  You have to fix me.”  So I began the work up again with X-rays, CT, MR, diagnostic SI injection.  She got good temporary relief.  No lasting relief.  She ended up having SIRF with, again temporary relief, no lasting relief.

Here are her imaging studies.  The lateral X-ray shows good incorporation of the femoral rings anteriorly.  Reasonable lordosis.  Good position of the instrumentation.  Disc height at L3-L4 is well maintained.  No real facet pathology.  No signs of instability.  On the AP film, the image on the left, you do appreciate sclerosis in the SI joints on both sides.  MRI of the lumbar spine, eight years post-op again shows disc height at L3-4 to be well maintained.  No central stenosis.  No significant facet arthropathy.  No lateral recess stenosis.  Her problem isn’t from the L3-L4 level.

Her MRI scan shows significant change on the T2 image.  With this dark signal in the ilium and both iliac and sacral signal change on the right side.  Also appreciated on the coronal.  Her CT scan is even more remarkable with vacuum phenomenon, which is the dark signal within the joint, bilaterally.  Sclerosis, spurring, cyst formation.  That where the arrow is that subchondral cyst.  And potentially even widening on the left side.

This patient was diagnosed with degenerative sacroilitis bilaterally, right side being much more symptomatic than left.  I performed an open right SI joint fusion with my standard technique.  Patient was kept partial weight bearing for eight weeks and the patient did well.  She was pleased and had significant relief of her right sided SI pain.

The patient returned to see me a year and a half later with complaints of increasing left sided SI joint pain.  I diagnosed her with a diagnostic injection.  Confirmed that she did, in fact, have degenerative sacroilitis on the left side.  And I performed an left sided SI joint fusion using the iFuse implant system.  She was quite happy and after the procedure, I was able to ask her which side she preferred.  And she, being my first patient as an internal control, was able to answer the question.  She stated she preferred the iFuse side to the open side.  I asked her why.  She said that on the iFuse side, when she woke up in the recovery room, she felt stable immediately after surgery.  On the open SI joint fusion side, she said she felt uncomfortable and not quite right for 2-3 months.  On the iFuse side, she was on crutches, partial weight bearing for three weeks.  On the open SI fusion side, she was on crutches for eight weeks.  In addition, she still complaints of discomfort over the right posterior iliac crest, where I took off a piece of the posterior crest and performed the open dissection.

The iFuse system is intended for sacroiliac joint fusion for conditions, including sacroiliac joint disruptions and degenerative sacroilitis.  As with all surgical procedures and permanent implants, there are risks and considerations associated with surgery and use of the iFuse implant.  Physicians should review the iFuse instructions for use for complete discussion of contra indications, warnings precuations and risks.  Patients should discuss these risks in consideration with their physician before deciding if this treatment option is right for them."