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Todd H. Lanman and Thomas J. Hopkins

Object

To evaluate the effectiveness of recombinant human bone morphogenetic protein–2 (rhBMP-2) combined with a bioresorbable implant, the authors conducted a prospective study of 43 patients with degenerative lumbar disc disease who underwent transforaminal lumbar interbody fusion.

Methods

The authors used Infuse bone graft, which consisted of rhBMP-2 applied to an absorbable collagen sponge and contained within a HYDROSORB Telamon bioresorbable implant to perform the fusion. Multilevel fusions were performed in 30% of the 43 patients, for a total of 57 levels. At 6 months postoperatively, x-ray films and computerized tomography (CT) scans demonstrated solid fusion in 98% of 41 patients. Improvement from the baseline Oswestry Disability Rating was demonstrated at 6 months postoperatively in 68% of the patients, based on the Oswestry Disability Questionnaire. At 12 months all 11 patients in whom CT scans were obtained showed complete bridging of bone; there were no device-related complications.

Conclusions

Results in this series provide evidence of the feasibility of using HYDROSORB Telamon biore-sorbable spacers in combination with Infuse bone graft for lumbar spine fusion.

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Todd H. Lanman and Thomas J. Hopkins

Object

The goal of this study was to assess the efficacy of bioabsorbable interbody spacers in cervical spine fusion.

Methods

The authors report on a prospective examination of 20 patients with degenerative cervical disc disease who underwent anterior cervical fusion at 28 total levels. The authors used Infuse bone graft (that is, recombinant human bone morphogenetic protein–2 applied to an absorbable collagen sponge and contained within a Cornerstone-HSR bioabsorbable spacer. Multiple-level fusions were performed in 30% of these patients. At 3 months postfusion, radiographs and computerized tomography scans demonstrated bridging bone in 100% of the patients. Improvement from baseline scores in physical functioning, mental health, and bodily pain was demonstrated at 3 months postoperatively according to results of the Short Form–36 Version 2 health survey. There were no device-related complications.

Conclusions

The results in this series indicate that the use of Cornerstone-HSR as a bioabsorbable interbody spacer in combination with Infuse bone graft may be an alternative treatment for cervical spine fusion.

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Todd H. Lanman, Derald E. Brackmann, William E. Hitselberger and Bill Subin

Object

The choice of approach for surgical removal of large acoustic neuromas is still controversial. The authors reviewed the results in a series of patients who underwent removal of large tumors via the translabyrinthine approach.

Methods

The authors conducted a database analysis of 190 patients (89 men and 101 women) with acoustic neuromas 3 cm or greater in size. The mean age of these patients was 46.1 ± 15.6 years. One hundred seventy-eight patients underwent primary translabyrinthine surgical removal and 12 underwent surgery for residual tumor. Total tumor removal was accomplished in 183 cases (96.3%). The tumor was adherent to the facial nerve to some degree in 64% of the cases, but the facial nerve was preserved anatomically in 178 (93.7%) of the patients. Divided nerves were repaired by primary attachment or cable graft. Facial nerve function was assessed immediately after surgery, at the time of discharge, and at 3 to 4 weeks and 1 year after discharge. Excellent function (House-Brackmann facial nerve Grade I or II) was present in 55%, 33.9%, 38.8%, and 52.6% of the patients for each time interval, respectively, with acceptable function (Grades I–IV) in 81% at 1 year. Cerebrospinal fluid leakage that required surgical repair occurred in only 1.1% of the patients and meningitis occurred in 3.7%. There were no deaths.

Conclusions

Use of the translabyrinthine approach for removal of large tumors resulted in good anatomical and functional preservation of the facial nerve, with minimum incidence of morbidity and no incidence of mortality. The authors continue to recommend use of this approach for acoustic tumors larger than 3 cm and for smaller tumors when hearing preservation is not an issue.

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Todd H. Lanman, Derald E. Brackmann, William E. Hitselberger and Bill Subin

Object. The choice of approach for surgical removal of large acoustic neuromas is still controversial. The authors reviewed the results in a series of patients who underwent removal of large tumors via the translabyrinthine approach.

Methods. The authors conducted a database analysis of 190 patients (89 men and 101 women) with acoustic neuromas 3 cm or greater in size. The mean age of these patients was 46.1 ± 15.6 years. One hundred seventy-eight patients underwent primary translabyrinthine surgical removal and 12 underwent surgery for residual tumor. Total tumor removal was accomplished in 183 cases (96.3%). The tumor was adherent to the facial nerve to some degree in 64% of the cases, but the facial nerve was preserved anatomically in 178 (93.7%) of the patients. Divided nerves were repaired by primary attachment or cable graft. Facial nerve function was assessed immediately after surgery, at the time of discharge, and at 3 to 4 weeks and 1 year after discharge. Excellent function (House—Brackmann facial nerve Grade I or II) was present in 55%, 33.9%, 38.8%, and 52.6% of the patients for each time interval, respectively, with acceptable function (Grades I—IV) in 81% at 1 year. Cerebrospinal fluid leakage that required surgical repair occurred in only 1.1% of the patients and meningitis in 3.7%. There were no deaths.

Conclusions. Use of the translabyrinthine approach for removal of large tumors resulted in good anatomical and functional preservation of the facial nerve, with minimum incidence of morbidity and no incidence of mortality. The authors continue to recommend use of this approach for acoustic tumors larger than 3 cm and for smaller tumors when hearing preservation is not an issue.

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Todd H. Lanman, J. Kenneth Burkus, Randall G. Dryer, Matthew F. Gornet, Jeffrey McConnell and Scott D. Hodges

OBJECTIVE

The aim of this study was to assess long-term clinical safety and effectiveness in patients undergoing anterior cervical surgery using the Prestige LP artificial disc replacement (ADR) prosthesis to treat degenerative cervical spine disease at 2 adjacent levels compared with anterior cervical discectomy and fusion (ACDF).

METHODS

A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted at 30 US centers, comparing the low-profile titanium ceramic composite-based Prestige LP ADR (n = 209) at 2 levels with ACDF (n = 188). Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative intervals to 84 months. The primary end point was overall success, a composite variable that included key safety and efficacy considerations.

RESULTS

At 84 months, the Prestige LP ADR demonstrated statistical superiority over fusion for overall success (observed rate 78.6% vs 62.7%; posterior probability of superiority [PPS] = 99.8%), Neck Disability Index success (87.0% vs 75.6%; PPS = 99.3%), and neurological success (91.6% vs 82.1%; PPS = 99.0%). All other study effectiveness measures were at least noninferior for ADR compared with ACDF. There was no statistically significant difference in the overall rate of implant-related or implant/surgical procedure–related adverse events up to 84 months (26.6% and 27.7%, respectively). However, the Prestige LP group had fewer serious (Grade 3 or 4) implant- or implant/surgical procedure–related adverse events (3.2% vs 7.2%, log hazard ratio [LHR] and 95% Bayesian credible interval [95% BCI] −1.19 [−2.29 to −0.15]). Patients in the Prestige LP group also underwent statistically significantly fewer second surgical procedures at the index levels (4.2%) than the fusion group (14.7%) (LHR −1.29 [95% BCI −2.12 to −0.46]). Angular range of motion at superior- and inferior-treated levels on average was maintained in the Prestige LP ADR group to 84 months.

CONCLUSIONS

The low-profile artificial cervical disc in this study, Prestige LP, implanted at 2 adjacent levels, maintains improved clinical outcomes and segmental motion 84 months after surgery and is a safe and effective alternative to fusion.

Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)

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Matthew F. Gornet, Todd H. Lanman, J. Kenneth Burkus, Randall F. Dryer, Jeffrey R. McConnell, Scott D. Hodges and Francine W. Schranck

OBJECTIVE

The authors assessed the 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) to treat degenerative cervical spine disease at 2 adjacent levels compared to anterior cervical discectomy and fusion (ACDF).

METHODS

A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted comparing the low-profile titanium ceramic composite–based Prestige LP Cervical Disc (n = 209) at two levels with ACDF (n = 188). Ten-year follow-up data from a postapproval study were available on 148 CDA and 118 ACDF patients and are reported here. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative follow-up intervals for up to 10 years. The primary endpoint was overall success, a composite variable that included key safety and efficacy considerations. Ten-year follow-up rates were 86.0% for CDA and 84.9% for ACDF.

RESULTS

From 2 to 10 years, CDA demonstrated statistical superiority over ACDF for overall success, with rates at 10 years of 80.4% versus 62.2%, respectively (posterior probability of superiority [PPS] = 99.9%). Neck Disability Index (NDI) success was also superior, with rates at 10 years of 88.4% versus 76.5% (PPS = 99.5%), as was neurological success (92.6% vs 86.1%; PPS = 95.6%). Improvements from preoperative results in NDI and neck pain scores were consistently statistically superior for CDA compared to ACDF. All other study effectiveness measures were at least noninferior for CDA compared to ACDF through the 10-year follow-up period, including disc height. Mean angular ranges of motion at treated levels were maintained in the CDA group for up to 10 years. The rates of grade IV heterotopic ossification (HO) at the superior and inferior levels were 8.2% and 10.3%, respectively. The rate of severe HO (grade III or IV) did not increase significantly from 7 years (42.4%) to 10 years (39.0%). The CDA group had fewer serious (grade 3–4) implant-related or implant/surgical procedure–related adverse events (3.8% vs 8.1%; posterior mean 95% Bayesian credible interval [BCI] of the log hazard ratio [LHR] −0.92 [−1.88, −0.01]). The CDA group also had statistically fewer secondary surgical procedures at the index levels (4.7%) than the ACDF group (17.6%) (LHR [95% BCI] −1.39 [−2.15, −0.61]) as well as at adjacent levels (9.0% vs 17.9%).

CONCLUSIONS

The Prestige LP Cervical Disc, implanted at two adjacent levels, maintains improved clinical outcomes and segmental motion 10 years after surgery and is a safe and effective alternative to fusion.

Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)

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Matthew F. Gornet, Todd H. Lanman, J. Kenneth Burkus, Scott D. Hodges, Jeffrey R. McConnell, Randall F. Dryer, Anne G. Copay, Hui Nian and Frank E. Harrell Jr.

OBJECTIVE

The authors compared the efficacy and safety of arthroplasty using the Prestige LP cervical disc with those of anterior cervical discectomy and fusion (ACDF) for the treatment of degenerative disc disease (DDD) at 2 adjacent levels.

METHODS

Patients from 30 investigational sites were randomized to 1 of 2 groups: investigational patients (209) underwent arthroplasty using a Prestige LP artificial disc, and control patients (188) underwent ACDF with a cortical ring allograft and anterior cervical plate. Patients were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Efficacy and safety outcomes were measured according to the Neck Disability Index (NDI), Numeric Rating Scales for neck and arm pain, 36-Item Short-Form Health Survey (SF-36), gait abnormality, disc height, range of motion (investigational) or fusion (control), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all 4 of the following criteria were met: 1) NDI score improvement of ≥ 15 points over the preoperative score, 2) maintenance or improvement in neurological status compared with preoperatively, 3) no serious AE caused by the implant or by the implant and surgical procedure, and 4) no additional surgery (supplemental fixation, revision, or nonelective implant removal). Independent statisticians performed Bayesian statistical analyses.

RESULTS

The 24-month rates of overall success were 81.4% for the investigational group and 69.4% for the control group. The posterior mean for overall success in the investigational group exceeded that in the control group by 0.112 (95% highest posterior density interval = 0.023 to 0.201) with a posterior probability of 1 for noninferiority and 0.993 for superiority, demonstrating the superiority of the investigational group for overall success. Noninferiority of the investigational group was demonstrated for all individual components of overall success and individual effectiveness end points, except for the SF-36 Mental Component Summary. The investigational group was superior to the control group for NDI success. The proportion of patients experiencing any AE was 93.3% (195/209) in the investigational group and 92.0% (173/188) in the control group, which were not statistically different. The rate of patients who reported any serious AE (Grade 3 or 4) was significantly higher in the control group (90 [47.9%] of 188) than in the investigational group (72 [34.4%] of 209) with a posterior probability of superiority of 0.996. Radiographic success was achieved in 51.0% (100/196) of the investigational patients (maintenance of motion without evidence of bridging bone) and 82.1% (119/145) of the control patients (fusion). At 24 months, heterotopic ossification was identified in 27.8% (55/198) of the superior levels and 36.4% (72/198) of the inferior levels of investigational patients.

CONCLUSIONS

Arthroplasty with the Prestige LP cervical disc is as effective and safe as ACDF for the treatment of cervical DDD at 2 contiguous levels and is an alternative treatment for intractable radiculopathy or myelopathy at 2 adjacent levels.

Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)