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Mark N. Hadley

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Domagoj Coric, Richard D. Guyer, Pierce D. Nunley, David Musante, Cameron Carmody, Charles Gordon, Carl Lauryssen, Margaret O. Boltes and Donna D. Ohnmeiss

OBJECTIVE

Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up.

METHODS

An FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR.

RESULTS

A total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but was significantly greater than the preoperative mean value at the 12- and 24-month follow-ups and remained significantly improved through the 60-month period. There were no significant differences between the 2 groups in terms of reoperation/revision surgery or device-/surgery-related adverse events. The serum ion analysis revealed cobalt and chromium levels significantly lower than the levels that merit monitoring.

CONCLUSIONS

Cervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy.

Clinical trial registration no.: NCT00374413 (clinicaltrials.gov)

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Peter G. Campbell, Pierce D. Nunley, David Cavanaugh, Eubulus Kerr, Philip Andrew Utter, Kelly Frank and Marcus Stone

OBJECTIVE

Recently, authors have called into question the utility and complication index of the lateral lumbar interbody fusion procedure at the L4–5 level. Furthermore, the need for direct decompression has also been debated. Here, the authors report the clinical and radiographic outcomes of transpsoas lumbar interbody fusion, relying only on indirect decompression to treat patients with neurogenic claudication secondary to Grade 1 and 2 spondylolisthesis at the L4–5 level.

METHODS

The authors conducted a retrospective evaluation of 18 consecutive patients with Grade 1 or 2 spondylolisthesis from a prospectively maintained database. All patients underwent a transpsoas approach, followed by posterior percutaneous instrumentation without decompression. The Oswestry Disability Index (ODI) and SF-12 were administered during the clinical evaluations. Radiographic evaluation was also performed. The mean follow-up was 6.2 months.

RESULTS

Fifteen patients with Grade 1 and 3 patients with Grade 2 spondylolisthesis were identified and underwent fusion at a total of 20 levels. The mean operative time was 165 minutes for the combined anterior and posterior phases of the operation. The estimated blood loss was 113 ml. The most common cage width in the anteroposterior dimension was 22 mm (78%). Anterior thigh dysesthesia was identified on detailed sensory evaluation in 6 of 18 patients (33%); all patients experienced resolution within 6 months postoperatively. No patient had lasting sensory loss or motor deficit. The average ODI score improved 26 points by the 6-month follow-up. At the 6-month follow-up, the SF-12 mean Physical and Mental Component Summary scores improved by 11.9% and 9.6%, respectively. No patient required additional decompression postoperatively.

CONCLUSIONS

This study offers clinical results to establish lateral lumbar interbody fusion as an effective technique for the treatment of Grade 1 or 2 degenerative spondylolisthesis at L4–5. The use of this surgical approach provides a minimally invasive solution that offers excellent arthrodesis rates as well as favorable clinical and radiological outcomes, with low rates of postoperative complications. However, adhering to the techniques of transpsoas lateral surgery, such as minimal table break, an initial look-and-see approach to the psoas, clear identification of the plexus, minimal cranial caudal expansion of the retractor, mobilization of any traversing sensory nerves, and total psoas dilation times less than 20 minutes, ensures the lowest possible complication profile for both visceral and neural injuries even in the narrow safe zones when accessing the L4–5 disc space in patients with degenerative spondylolisthesis.

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Robert J. Jackson, Reginald J. Davis, Gregory A. Hoffman, Hyun W. Bae, Michael S. Hisey, Kee D. Kim, Steven E. Gaede and Pierce Dalton Nunley

OBJECTIVE

Cervical total disc replacement (TDR) has been shown in a number of prospective clinical studies to be a viable treatment alternative to anterior cervical discectomy and fusion (ACDF) for the treatment of symptomatic degenerative disc disease. In addition to preserving motion, evidence suggests that cervical TDR may result in a lower incidence of subsequent surgical intervention than treatment with fusion. The goal of this study was to evaluate subsequent surgery rates up to 5 years in patients treated with TDR or ACDF at 1 or 2 contiguous levels between C-3 and C-7.

METHODS

This was a prospective, multicenter, randomized, unblinded clinical trial. Patients with symptomatic degenerative disc disease were enrolled to receive 1- or 2-level treatment with either TDR as the investigational device or ACDF as the control treatment. There were 260 patients in the 1-level study (179 TDR and 81 ACDF patients) and 339 patients in the 2-level study (234 TDR and 105 ACDF patients).

RESULTS

At 5 years, the occurrence of subsequent surgical intervention was significantly higher among ACDF patients for 1-level (TDR, 4.5% [8/179]; ACDF, 17.3% [14/81]; p = 0.0012) and 2-level (TDR, 7.3% [17/234]; ACDF, 21.0% [22/105], p = 0.0007) treatment. The TDR group demonstrated significantly fewer index- and adjacent-level subsequent surgeries in both the 1- and 2-level cohorts.

CONCLUSIONS

Five-year results showed treatment with cervical TDR to result in a significantly lower rate of subsequent surgical intervention than treatment with ACDF for both 1 and 2 levels of treatment.

Clinical trial registration no.: NCT00389597 (clinicaltrials.gov)

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Reginald J. Davis, Kee D. Kim, Michael S. Hisey, Gregory A. Hoffman, Hyun W. Bae, Steven E. Gaede, Ralph F. Rashbaum, Pierce Dalton Nunley, Daniel L. Peterson and John K. Stokes

Object

Cervical total disc replacement (TDR) is intended to treat neurological symptoms and neck pain associated with degeneration of intervertebral discs in the cervical spine. Anterior cervical discectomy and fusion (ACDF) has been the standard treatment for these indications since the procedure was first developed in the 1950s. While TDR has been shown to be a safe and effective alternative to ACDF for treatment of patients with degenerative disc disease (DDD) at a single level of the cervical spine, few studies have focused on the safety and efficacy of TDR for treatment of 2 levels of the cervical spine. The primary objective of this study was to rigorously compare the Mobi-C cervical artificial disc to ACDF for treatment of cervical DDD at 2 contiguous levels of the cervical spine.

Methods

This study was a prospective, randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc conducted at 24 centers in the US. The primary clinical outcome was a composite measure of study success at 24 months. The comparative control treatment was ACDF using allograft bone and an anterior plate. A total of 330 patients were enrolled, randomized, and received study surgery. All patients were diagnosed with intractable symptomatic cervical DDD at 2 contiguous levels of the cervical spine between C-3 and C-7. Patients were randomized in a 2:1 ratio (TDR patients to ACDF patients).

Results

A total of 225 patients received the Mobi-C TDR device and 105 patients received ACDF. At 24 months only 3.0% of patients were lost to follow-up. On average, patients in both groups showed significant improvements in Neck Disability Index (NDI) score, visual analog scale (VAS) neck pain score, and VAS arm pain score from preoperative baseline to each time point. However, the TDR patients experienced significantly greater improvement than ACDF patients in NDI score at all time points and significantly greater improvement in VAS neck pain score at 6 weeks, and at 3, 6, and 12 months postoperatively. On average, patients in the TDR group also maintained preoperative segmental range of motion at both treated segments immediately postoperatively and throughout the study period of 24 months. The reoperation rate was significantly higher in the ACDF group at 11.4% compared with 3.1% for the TDR group. Furthermore, at 24 months TDR demonstrated statistical superiority over ACDF based on overall study success rates.

Conclusions

The results of this study represent the first available Level I clinical evidence in support of cervical arthroplasty at 2 contiguous levels of the cervical spine using the Mobi-C cervical artificial disc. These results continue to support the use of cervical arthroplasty in general, but specifically demonstrate the advantages of 2-level arthroplasty over 2-level ACDF. Clinical trial registration no.: NCT00389597 (ClinicalTrials.gov).

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Domagoj Coric, Pierce D. Nunley, Richard D. Guyer, David Musante, Cameron N. Carmody, Charles R. Gordon, Carl Lauryssen, Donna D. Ohnmeiss and Margaret O. Boltes

Object

Cervical total disc replacement (CTDR) represents a relatively novel procedure intended to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. This prospective, randomized, multicenter study evaluates the safety and efficacy of a new metal-on-metal CTDR implant (Kineflex|C) by comparing it with ACDF in the treatment of single-level spondylosis with radiculopathy.

Methods

The study was a prospective, randomized US FDA Investigational Device Exemption (IDE) pivotal trial conducted at 21 centers across the US. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS) scores, and a composite measure of clinical success. Patients were randomized to CTDR using the Kineflex|C (SpinalMotion, Inc.) cervical artificial disc or ACDF using structural allograft and an anterior plate.

Results

A total of 269 patients were enrolled and randomly assigned to either CTDR (136 patients) or to ACDF (133 patients). There were no significant differences between the CTDR and ACDF groups when comparing operative time, blood loss, length of hospital stay, or the reoperation rate at the index level. The overall success rate was significantly greater in the CTDR group (85%) compared with the ACDF group (71%) (p = 0.05). In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 24-month follow-up (p < 0.0001). Similarly, the VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 24-month follow-up (p < 0.0001). The range of motion (ROM) in the CTDR group decreased at 3 months but was significantly greater than the preoperative mean at 12- and 24-month follow-up. The ROM in the ACDF group was significantly reduced by 3 months and remained so throughout the follow-up. Adjacent-level degeneration was also evaluated in both groups from preoperatively to 2-year follow-up and was classified as none, mild, moderate, or severe. Preoperatively, there were no significant differences between groups when evaluating the different levels of adjacent-level degeneration. At the 2-year follow-up, there were significantly more patients in the ACDF group with severe adjacent-level radiographic changes (p < 0.0001). However, there were no significant differences between groups in adjacent-level reoperation rate (7.6% for the Kineflex|C group and 6.1% for the ACDF group).

Conclusions

Cervical total disc replacement allows for neural decompression and clinical results comparable to ACDF. Kineflex|C was associated with a significantly greater overall success rate than fusion while maintaining motion at the index level. Furthermore, there were significantly fewer Kineflex|C patients showing severe adjacent-level radiographic changes at the 2-year follow-up. These results from a prospective, randomized study support that Kineflex|C CTDR is a viable alternative to ACDF in select patients with cervical radiculopathy.

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Pierce D. Nunley, Marcus B. Stone, Michael S. Hisey, Kee D. Kim, Robert J. Jackson, Hyun W. Bae, Gregory A. Hoffman, Steven E. Gaede, Guy O. Danielson III, Charles Gordon, Reginald J. Davis and Bimal Rami

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Reginald J. Davis, Pierce Dalton Nunley, Kee D. Kim, Michael S. Hisey, Robert J. Jackson, Hyun W. Bae, Gregory A. Hoffman, Steven E. Gaede, Guy O. Danielson III, Charles Gordon and Marcus B. Stone

OBJECT

The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up.

METHODS

A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the US. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery.

RESULTS

At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure.

CONCLUSIONS

Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels.

Clinical trial registration no.: NCT00389597 (clinicaltrials.gov)

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Khoi D. Than, Praveen V. Mummaneni, Kelly J. Bridges, Stacie Tran, Paul Park, Dean Chou, Frank La Marca, Juan S. Uribe, Todd D. Vogel, Pierce D. Nunley, Robert K. Eastlack, Neel Anand, David O. Okonkwo, Adam S. Kanter and Gregory M. Mundis Jr.

OBJECTIVE

High-quality studies that compare outcomes of open and minimally invasively placed pedicle screws for adult spinal deformity are needed. Therefore, the authors compared differences in complications from a circumferential minimally invasive spine (MIS) surgery and those from a hybrid surgery.

METHODS

A retrospective review of a multicenter database of patients with spinal deformity who were treated with an MIS surgery was performed. Database inclusion criteria included an age of ≥ 18 years and at least 1 of the following: a coronal Cobb angle of > 20°, a sagittal vertical axis of > 5 cm, a pelvic incidence–lumbar lordosis angle of > 10°, and/or a pelvic tilt of > 20°. Patients were propensity matched according to the levels instrumented.

RESULTS

In this database, a complete data set was available for 165 patients, and after those who underwent 3-column osteotomy were excluded, 137 patients were available for analysis; 76 patients remained after propensity matching (MIS surgery group 38 patients, hybrid surgery group 38 patients). The authors found no difference in demographics, number of levels instrumented, or preoperative and postoperative radiographic results. At least 1 complication was suffered by 55.3% of patients in the hybrid surgery group and 44.7% of those in the MIS surgery group (p = 0.359). Patients in the MIS surgery group had significantly fewer neurological, operative, and minor complications than those in the hybrid surgery group. The reoperation rates in both groups were similar. The most common complication category for the MIS surgery group was radiographic and for the hybrid surgery group was neurological. Patients in both groups experienced postoperative improvement in their Oswestry Disability Index and visual analog scale (VAS) back and leg pain scores (all p < 0.05); however, MIS surgery provided a greater reduction in leg pain according to VAS scores.

CONCLUSIONS

Overall complication rates in the MIS and hybrid surgery groups were similar. MIS surgery resulted in significantly fewer neurological, operative, and minor complications. Reoperation rates in the 2 groups were similar, and despite complications, the patients reported significant improvement in their pain and function.

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Michael Y. Wang, Stacie Tran, G. Damian Brusko, Robert Eastlack, Paul Park, Pierce D. Nunley, Adam S. Kanter, Juan S. Uribe, Neel Anand, David O. Okonkwo, Khoi D. Than, Christopher I. Shaffrey, Virginie Lafage, Gregory M. Mundis Jr., Praveen V. Mummaneni and the MIS-ISSG Group

OBJECTIVE

The past decade has seen major advances in techniques for treating more complex spinal disorders using minimally invasive surgery (MIS). While appealing from the standpoint of patient perioperative outcomes, a major impediment to adoption has been the significant learning curve in utilizing MIS techniques.

METHODS

Data were retrospectively analyzed from a multicenter series of adult spinal deformity surgeries treated at eight tertiary spine care centers in the period from 2008 to 2015. All patients had undergone a less invasive or hybrid approach for a deformity correction satisfying the following inclusion criteria at baseline: coronal Cobb angle ≥ 20°, sagittal vertical axis (SVA) > 5 cm, or pelvic tilt > 20°. Analyzed data included baseline demographic details, severity of deformity, surgical metrics, clinical outcomes (numeric rating scale [NRS] score and Oswestry Disability Index [ODI]), radiographic outcomes, and complications. A minimum follow-up of 2 years was required for study inclusion.

RESULTS

Across the 8-year study period, among 222 patients, there was a trend toward treating increasingly morbid patients, with the mean age increasing from 50.7 to 62.4 years (p = 0.013) and the BMI increasing from 25.5 to 31.4 kg/m2 (p = 0.12). There was no statistical difference in the severity of coronal and sagittal deformity treated over the study period. With regard to radiographic changes following surgery, there was an increasing emphasis on sagittal correction and, conversely, less coronal correction. There was no statistically significant difference in clinical outcomes over the 8-year period, and meaningful improvements were seen in all years (ODI range of improvement: 15.0–26.9). Neither were there statistically significant differences in major complications; however, minor complications were seen less often as the surgeons gained experience (p = 0.064). Operative time was decreased on average by 47% over the 8-year period.

Trends in surgical practice were seen as well. Total fusion construct length was unchanged until the last year when there was a marked decrease in conjunction with a decrease in interbody levels treated (p = 0.004) while obtaining a higher degree of sagittal correction, suggesting more selective but powerful interbody reduction methods as reflected by an increase in the lateral and anterior column resection techniques being utilized.

CONCLUSIONS

The use of minimally invasive methods for adult spinal deformity surgery has evolved over the past decade. Experienced surgeons are treating older and more morbid patients with similar outcomes. A reliance on selective, more powerful interbody approaches is increasing as well.