Quote:
Originally Posted by bogiewan
DEL.TEXT
... Dr. Don Kovalsky in Mount Vernon Ill. He was a principal investigator during the Prodisc clinical trials. He wants to do a hybrid surgery of fusion at L4-L5 and Prodisc at L5-S1.
DEL.TEXT
1. It seems like a lot of people are going out of country, am I missing something?
2. Has there been any experience with Dr. Don Kovalsky in Mount Vernon Ill?
3. Has anyone had this hybrid surgery in the lumbar?
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Ans.1: Some people go out of country due to insurance coverage positions, paying out of pocket, surgeon preference, device preference, etc.
Ans.2: No. I am in California.
Ans3: No surgery yet on this side, although scheduled with an orthopaedic surgeon again.
You wrote
Dr. Kovalsky was a
ProDisc investigator. I trust his opinon more than my own on the correct path for you.
There may be a challenge to line up the mean center of rotation of a multi-level ADR strategy.
The PDF attachment is:
EuroSpine 2008
SP 3
Hybrid construct: fusion L5S1 and disc arthroplasty L4L5 for DDD.
3 years follow up
• JC Le Huec MD PhD, S Aunoble MD, R Meyrat MD, C Tournier MD,
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
2009 North American Spine Society, Annual Meeting, Poster #158
158. The Hybrid ADR: Long-Term Analysis of Sagittal Motion and Clinical Outcome after Concurrent ADR + ALIF (Minimum 2-Year Follow-Up)
Alexandre Rasouli, MD 1, Rick B Delamarter, MD 2, L.E.A. Kanim, MA2, Nomaan Ashraf, MD 2, Brandon Strenge, Sr., MD 2;
1 University of California, Irvine, Newport Coast, CA, USA;
2 The Spine Institute at Santa Monica, Santa Monica, CA, USA
BACKGROUND CONTEXT:
A recent FDA-sponsored randomized controlled study of the Prodisc-L (Synthes Spine, Westchester, PA) lumbar disc replacement established superior clinical outcomes with preservation of motion at both surgical and adjacent levels, as compared to lumbar fusion.
Patients frequently present with pathology at the L4-L5 and L5-S1 levels and are not candidates for arthroplasty at the L5-S1 segment.
PURPOSE:
This study sought to evaluate clinical outcomes and the sagittal range of motion of single-level ProDisc-L ADR adjacent to a concurrent ALIF (InFix stand-alone cage, Abbott Spine, Austin, TX).
STUDY DESIGN/SETTING:
Prospective Cohort.
PATIENT SAMPLE:
Twenty-three patients underwent simultaneous lumbar
ADR at L4-L5 and ALIF at L5-S1.
OUTCOME MEASURES:
Radiographic evidence of motion in the sagittal plane pre-and post-operatively at the operated and adjacent levels were measured.
Oswestry Disability Index (ODI), Visual Analog Score Pain (VAS-P), and Visual Analog Score Satisfaction (VAS-S) data were also collected.
METHODS:
Patients were evaluated pre-operatively, at six weeks, three months, six months, and annually for 2-5 years postoperatively with lateral flexion-extension dynamic films and with completion of Oswestry and VAS surveys.
RESULTS:
At the motion segment adjacent to the ADRþALIF constructs (L3-L4), the mean preoperative range of motion was 8.49(SD 2.83), compared to 8.67postoperatively (SD 2.55, pO0.50). The mean preoperative range of motion at levels undergoing ADR (L4-L5) was 10.15(SD 2.71) versus 12.28postoperatively (SD 2.63, p50.011). The mean preoperative range of motion at the L5-S1 segment to undergo fusion was 1.90(SD 2.44), with all patients’ having a postoperative range of motion of 0.00 (pO0.05). At 2-5 years postoperatively, all patients had significant reductions in both ODI and VAS scores relative to preoperative levels (p!0.05). There
were no revision surgeries or reoperations at adjacent levels.
CONCLUSIONS:
The use of the hybrid ADR - ALIF construct does not
inhibit the efficacy of fusion at the ALIF level nor does it inhibit preservation of ROM at the ADR level. Most significantly, the nonoperative level adjacent to the hybrid construct maintains its preoperative ROM at 2-5 years postoperatively. There were no revision surgeries or reoperations at adjacent levels. Clinically, patients demonstrate significant improvement in pain and reduction in disability.
FDA DEVICE/DRUG STATUS:
ProDisc-L: Investigational/Not approved; IN-FIX: Investigational/Not approved.
doi: 10.1016/j.spinee.2009.08.194
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
ProDisc two-level FDA IDE results are positive as reported on ADRsupport.org/forums/
LINK . The results below in JBJS are two ADR/TDR devices,
not Hybrid.
Pubmed ID:
21398574
The Journal of Bone & Joint Surgery, Volume 93, Issue 8
J Bone Joint Surg Am. 2011; 93:e41 1-2 doi:10.2106/JBJS.J.01847
© 2011 The Journal of Bone and Joint Surgery, Inc
Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the
ProDisc-L Total Disc Replacement Compared with
Circumferential Arthrodesis for the
Treatment of Two-Level Lumbar Degenerative Disc Disease: Results at Twenty-four Months
Rick Delamarter, MD1; Jack E. Zigler, MD2; Richard A. Balderston, MD3; Frank P. Cammisa, MD4; Jeffrey A. Goldstein, MD5; Jeffrey M. Spivak, MD5
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
ProDisc is semi-constrained in design. Charite' is unconstrained. One reference on unconstrained two-level ADR with Charite' is from Drs. Schmidt, Zander, Rohlman, Galbusera and H.J. Wilke/Germany, pubmed
20361341 pointing more towards a hybrid.
I recall other journal articles from Drs. Zander, Rohlmann and Wilke wrote in (Journal of Biomechanics, Clinical Biomechanics, ...).