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Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_III | Pages 455 - 456
1 Oct 2006
Pimenta L Scott-Young M Cappuccino A McAfee P
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Introduction This is a prospective, consecutive series of 178 prosthetic implantations to analyse single level versus multiple level cervical arthroplasty with two years minimum follow-up

Methods Fifty-five patients underwent a total of fifty-five Porous Coated Motion (PCM) cervical arthroplasties from C3–4 to C7–T1 (Group S for single level). Fifty-four patients underwent one hundred and nine multilevel PCM cervical arthroplasties (Group M for multilevel) during the same time interval, for the same indications, performed by the same surgeons under the same clinical protocol— double level, 43 cases; three levels, 7 cases: and four levels, 4 cases. Sixteen PCM cases had been performed as complex revision procedures with prior fusions—9 in Group S and 7 in Group M. They included 1 previous Bryan Disc, 1 cage-plate, 1 patient with Klippel-Feil disease, 3 patients had failed lordotic cervical cages. One additional patient in Group M had a fracture-dislocation at C4–5 with a pseudarthrosis at C3–4 and C5–6. The demographics between Group S and Group M were very similar—mean age of patients, gender, severity of neurologic symptoms and distribution of radicular and myeloradicular symptoms.

Results There were no deaths, no infections, and no instances of iatrogenic neurologic progression in either the single level or the multiple level arthroplasty group. The mean EBL, length of surgery, and length of hospital stay were greater for the Multilevel Group. In contrast to these three operative demographic statistics, the self assessment outcomes instruments consistently showed more improvement for the multilevel cases. The mean improvement in the NDI for the single cases was 54.8 % (+/− 20.9) versus the multilevel cases mean improvement in NDI was 64.8 % (+/− 33.7). The mean improvement in the VAS showed the same relationship—single level mean improvement 62.0 % (26.9) versus the multilevel cases mean VAS improvement was 68.1% (+/− 31.4). The SF-36, Odoms, and TIGT were also more improved for the multilevel versus the single level group. The reoperation rates, adverse events, and incidence of complications were the same between the single level to the multilevel arthroplasty groups.

Discussion This prospective report of cervical arthroplasty demonstrates that each cervical vertebral level is biomechanically independent of the adjacent level, whether it contains an arthoplasty or an unoperated intervertebral disc. With the Porous Coated Motion cervical arthroplasty the incidence of reoperation did not increase proportionately higher as the number of cervical levels requiring instrumentation increased. Even in three and four level arthroplasty the true benefits of cervical disk replacement outcomes were demonstrated on functional clinical outcomes at minimum two-year follow-up


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_III | Pages 455 - 455
1 Oct 2006
Pimenta L Scott-Young M Cappuccino A McAfee P
Full Access

Introduction Adjacent segment disease with radiculopathy and neurologic deficit adjacent to a non-mobile spinal segment is the ideal application for cervical arthroplasty. Not only are the stresses and loads increased but unfortunately the previously fused segment is further compromised by being fixed in a kyphotic position.

Methods This is a prospective study of 40 PCM prostheses inserted in thirty patients with 50 adjacent segments previously fused or rendered immobile—ten cases were performed as bi-level implantations. The inclusion and exclusion criteria were otherwise identical to the normal FDA prospective IDE criteria with all patients presenting with radiculopathy and a corresponding neurologic deficit confirmed by an MRI compressive lesion.

Results The mean preoperative cervical lordosis was 2.65 degrees (−32 to 25), mean postoperative lordosis 12.3 degrees (−17 to 30), and the mean improvement was 9.4 degrees of cervical lordosis (range (−15 to 23). EBL = 0 to 100 cc with no patients requiring blood transfusions, Length of surgery = mean 104 minutes (60 to 150) and the length of hospital stay = mean 1.17 days (0 to 3 days). The clinical follow-up was greater than 2 years. All patients were neurologically intact at follow up with a mean improvement of NDI = 50 % and mean improvement in VAS = 58.3 %.The range of flexion and extension motion at the level of the prosthesis was a mean of 8.9 degrees (range 4 to 20 degrees).

Discussion Naturally, the adjacent segment application of a cervical disc replacement is a challenging clinical environment for cervical arthroplasty – by definition every case had prior surgery. Not only is the cervical spine position often compromised by being in excessive kyphosis, but seventeen of the 50 previously fused levels had prior cervical instrumentation. 5 patients had previous cervical cages, 2 had cage-plates, 5 patients had previous anterior cervical plates, one had a prior arthroplasty device with HO, and 4 patients had PMMA which required revision. Despite the complicated nature of the presenting pathology, the Porous Coated Motion Cervical prosthesis successfully restored some element of cervical lordosis, and restored stability to the cervical segments. An added potential bonus is the preserved 9.4 degrees of flexion – extension mobility. The PCM appeared to work well in these revision cases. This is the world’s largest study to date investigating prospectively the value of cervical arthroplasty in adjacent segment disease.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 410 - 411
1 Sep 2005
Cunningham B Hu N Sefter J Cappuccino A Pimenta L McAfee P
Full Access

Introduction The current study was undertaken to investigate the biomechanical and biologic in-growth characteristics of the Porous Coated Motion™ cervical disc prosthesis following a six and twelve-month implant duration using an in-vivo caprine model.

Methods Twelve mature Nubian goats were divided into two groups based on post-operative survival periods of six (n=6) and twelve months (n=6). Using an anterior surgical approach, a complete diskectomy was performed at the C3-C4, followed by implantation of the Porous Coated Motion™ device. Functional outcomes of the disc prosthesis were based on computed tomography (CT), multi-directional flexibility testing, undecalcifed histology, histomorphometry and immunocytochemical analyses.

Results There was no evidence of prosthesis loosening, neurologic or vascular complications. CT scans demonstrated the ability to image and assess the cervical spinal canal for the presence of compressive pathology in the area of the CoCrMo prosthesis. Multi-directional flexibility testing indicated no differences in full range of intervertebral motion between the disc prosthesis and non-operative controls (n=7) under axial rotation or lateral bending conditions (p> 0.05). Flexion-extension produced significantly more motion for the intact spine compared to the cervical disc prosthesis (p< 0.05). Based on immunohistochemical and histologic analysis, there was no evidence of particulate debris, cytokines or cellular apoptosis within the local tissues overlying the operative site or systemic tissues. Moreover, review of the spinal cord at the operative levels indicated no evidence of cord lesions, inflammatory reaction, wear particles or significant pathologic changes in any treatment. Histomorphometric analysis at the metal-bone interface indicated the mean trabecular ingrowth of 40.5±24.4% at six-months and 58.65% ± 28.04 at twelve months.

Discussion All twelve goats undergoing cervical disc replacement had no evidence of implant loosening or inflammatory reactions from particulate wear debris. Segmental intervertebral motion was preserved based on multi-directional flexibility testing. The TiCaP porous ingrowth surface provided some immediate advantages for endplate osseointegration as there was no evidence of implant subluxation, despite immediate post-operative unrestricted cervical activity. Following cervical disc replacement, histological osseointegration at the implant-bone interface is possible, while preserving segmental motion.