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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)

Study design A prospective, randomized, multicenter Food and Drug Administration Investigation Device Exemption study using total disc replacement as surgical treatment of degenerative disc disease at 1 or 2 contiguous levels of the cervical spine. Objective To evaluate the safety and effectiveness of total disc replacement at single or 2 contiguous levels through 48 months of follow-up. Summary of background data Cervical total disc replacement has been shown to be a safe and effective alternative to anterior cervical discectomy and fusion at 24 months. Its motion-preserving capabilities may avoid accelerating adjacent segment pathology and thereby lower the rate of associated complications. Methods Patients were randomized in a 2:1 ratio (total disc replacement [TDR]: anterior cervical discectomy and fusion [ACDF]) at 24 sites. Ultimately, 164 patients received TDR at 1 level and 225 patients received TDR at 2 contiguous levels. An additional 24 patients (15 one-level, 9 two-level) were treated with TDR as training cases.Outcome measures included neck disability index, visual analogue scale neck and arm pain, Short Form 12-item Health Survey (SF-12) Mental Composite Score (MCS) and Physical Composite Score (PCS), range of motion, major complication rates, and secondary surgery rates. Patients received follow-up examinations at regular intervals through 4 years after surgery. Results Preoperative characteristics were statistically similar for the 1- and 2-level patient groups. Four-year follow-up rates were 83.1% (1-level) and 89.0% (2-level). There was no statistically significant difference between 1- and 2-level TDR groups for all clinical outcome measures. Both TDR groups experienced significant improvement at each follow-up when compared with preoperative scores. One case of migration was reported in the 2-level TDR group. Conclusion A 4-year post hoc comparison of 1- and 2-level TDR patients concurrently enrolled in a 24-center, Food and Drug Administration Investigation Device Exemption clinical trial indicated no statistical differences between groups in clinical outcomes, overall complication rates, and subsequent surgery rates. Level of evidence 1.

Study design Prospective randomized clinical trials. Objective To compare the outcome data with respect to clinical success rates and incidence of adjacent level disease (ALD) in patients after total disc arthroplasty (TDA) or anterior cervical fusion (ACDF) for 1- and 2-level cervical disc disease. Summary of background data Previously published studies have provided evidence that ACDF procedure for cervical degenerative disc disease (DDD) may increase the stress on the nonoperated adjacent cervical segments, thus possibly increasing the risk of degeneration at these levels. The theoretical assumption that TDA may reduce the incidence of future ALD by preserving motion at the affected segments has, however, never been validated by clinical evidence. Methods One hundred seventy patients with established symptomatic cervical disc disease at 1 or 2 levels participated in 3 prospective randomized clinical trials at 2 institutions. Participating subjects were randomized to receive TDA (treatment; n = 113) or ACDF (control; n = 57) by 6 independent investigating surgeons. Visual analogue pain scores (0-100), Neck Disability Index, neurological examination, and cervical spine radiographs were collected at enrollment and then 6 weeks and 3, 6, 12, 24, 36, and 48 months after surgery. Patients with persistent symptoms during the follow-up period were investigated for adjacent segment disease (ASD) with computed tomography/magnetic resonance imaging of the cervical spine, neurophysiology, and subsequent active interventions. Results At the median follow-up of 42 months (range: 28-54 months), 9 (14.3%) ACDF and 19 (16.8%) TDA patients developed and were actively treated for ASD. Osteopenia dust energy x-ray absorptiometry T scores of -1.5 to -2.4) (P = 0.04; 95% confidence interval [CI]: 0.007-0.223) and concurrent lumbar degenerative disease (P = 0.02; 95% CI: 0.003-0.196) significantly increased the risk of ASD. Conclusion The risk of developing adjacent segment degeneration was equivalent at median 38 months after both ACDF and TDA procedures in cervical DDD. Osteopenia and concurrent lumbar DDD significantly increase the risk of ALD.

A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial.To evaluate the safety and effectiveness of the ProDisc-L (Synthes Spine, West Chester, PA) lumbar total disc replacement compared to circumferential spinal fusion for the treatment of discogenic pain at 1 vertebral level between L3 and S1.As part of the Investigational Device Exemption clinical trial, favorable single center results of lumbar total disc replacement with the ProDisc-L have been reported previously.Two hundred eighty-six (286) patients were treated on protocol. Patients were evaluated before and after surgery, at 6 weeks, 3, 6, 12, 18, and 24 months. Evaluation at each visit included patient self-assessments, physical and neurologic examinations, and radiographic evaluation.Safety of ProDisc-L implantation was demonstrated with 0% major complications. At 24 months, 91.8% of investigational and 84.5% of control patients reported improvement in the Oswestry Low Back Pain Disability Questionnaire (Oswestry Disability Index [ODI]) from preoperative levels, and 77.2% of investigational and 64.8% of control patients met theor =15% Oswestry Disability Index improvement criteria. Overall neurologic success in the investigational group was superior to the control group (91.2% investigational and 81.4% control; P = 0.0341). At 6 weeks and 3 months follow-up time points, the ProDisc-L patients recorded SF-36 Health Survey scores significantly higher than the control group (P = 0.018, P = 0.0036, respectively). The visual analog scale pain assessment showed statistically significant improvement from preoperative levels regardless of treatment (P0.0001). Visual analog scale patient satisfaction at 24 months showed a statistically significant difference favoring investigational patients over the control group (P = 0.015). Radiographic range of motion was maintained within a normal functional range in 93.7% of investigational patients and averaged 7.7 degrees.ProDisc-L has been found to be safe and efficacious. In properly chosen patients, ProDisc-L has been shown to be superior to circumferential fusion by multiple clinical criteria.

Study Design. This was a prospective multicenter clinical trial of a lumbar interbody fusion cage with a minimum of 4 years'follow-up. Objectives. To determine whether the early positive clinical results in fusions with lumbar cages, such as the Bagby and Kuslich (BAK) cage, are maintained beyond 2 years. Summary of Background Data. Threaded cages have been used increasingly for the treatment of symptomatic degenerative intervertebral disc disease. Concerns about the long-term clinical outcomes of this procedure have been posed, particularly regarding bony fusion viability, revision rates, potential adjacent level disease, and late complications. Methods. The study cohort was a 196-patient subset from a prospective investigational device exemption. In addition to early postoperative examinations, these patients were examined biannually with a minimum of 4 years' follow-up. Patient outcome was assessed by a 6-point scale that evaluated pain relief, and functional improvement was determined by changes in activities of daily living. Fusion rates and return to work were determined. Complications and secondary operations were reported and categorized as non-device related or device related. Results. The patient cohort with 4-year follow-up represented 25.6% of the original study population eligible at that time. Overall, the largest percentage of pain relief and functional improvements occurred by 3 months, and these improvements were maintained at each follow-up. Overall fusion rate was 91.7% and 95.1% at 2 and 4 years, respectively. In this cohort, 39.5% of patients were working or were able to work within 3 months of surgery. After 4 years, 62.7% of patients were gainfully employed or able to work. The late-occurring complication rate in this cohort was 13.8% (27/196). Complications necessitating a second operation occurred in 8.7% (17/196), whereas re-operations that were deemed device related were performed in 3.1% (6/196). Conclusions. This study indicates that the early positive benefits of interbody fusion cage procedures are maintained through 4 years with acceptably low morbidity.

Deafness in the student of the elementary and secondary schools remains a challenge to educators, parents, and to the physician. Education of the parent and the instructor, of the student, is one of the keynotes of its possible correction. The family physician and the otologist must be ever on the lookout for minimal deafness or have the problem referred to them for diagnosis and possible therapy. The parent often honestly believes the student is daydreaming and thus does not pay attention when spoken to. The parent often tells the examiner, "My Johnny hears when it is something he wants to hear, but never hears when asked to do something." The instructors, in their busy schedule, often believe the same of the student and do not have the time to delve into the individual problem. Many articles have appeared in the journals concerning state-wide and metropolitan investigations of youth hearing problems.