The value of somatosensory- and motor-evoked potentials in predicting and monitoring the effect of therapy in spondylotic cervical myelopathy. Prospective randomized study. Cervical collar or physiotherapy versus wait and see policy for recent onset cervical radiculopathy: randomised trial. Anterior cervical fusion with interbody cage containing beta-tricalcium phosphate augmented with plate fixation: a prospective randomized study with 2-year follow-up. Anterior cervical discectomy with or without fusion with ray titanium cage: a prospective randomized clinical study. Discectomy versus discectomy with fusion versus discectomy with fusion and instrumentation: a prospective randomized study. Outcome scores in degenerative cervical disc surgery. Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. Reduction of leg pain and lower-extremity weakness for 1 year with Oxiplex/SP gel following laminectomy, laminotomy, and discectomy. A controlled study of microsurgical versus standard lumbar discectomy.
A 2-year follow-up prospective randomized electrophysiologic and clinical study of patients with spondylotic cervical myelopathy.
                To assess the value of somatosensory- and motor-evoked potentials in the evaluation and prediction of the effect of therapy.
                Previous studies have yielded conflicting data concerning the correlation between the changes in evoked potential parameters and the clinical postsurgical outcome in spondylotic cervical myelopathy.
                Sixty-one patients with magnetic resonance images suggesting spondylotic cervical cord compression and clinical signs of cervical myelopathy were divided into two groups according to the degree of clinical cervical cord involvement. The 49 patients with mild and moderate spondylotic cervical myelopathy were randomized into groups that underwent either surgical or conservative therapy. Patients were evaluated clinically and by the means of somatosensory- and motor-evoked potentials.
                The clinical and evoked potential changes showed good correlation on the group level, but poor correlation intraindividually. There were no significant evoked potential and clinical group changes after 6 months and 2 years in the mild myelopathy group treated either surgically and conservatively, whereas patients with severe myelopathy displayed significant improvement in clinical and evoked potential parameters after surgery. In a subgroup of patients, the isolated segmental medullar N13 abnormality could potentially predict favorable postsurgical clinical outcome.
                Longitudinal evoked potentials showed limited use for evaluating the results of therapy in an individual patient. They could be useful in the group assessment of therapy results and in labeling a subgroup of patients with potentially favorable postsurgical outcome. To evaluate the effectiveness of treatment with collar or physiotherapy compared with a wait and see policy in recent onset cervical radiculopathy.
                Randomised controlled trial.
                Neurology outpatient clinics in three Dutch hospitals.
                205 patients with symptoms and signs of cervical radiculopathy of less than one month's duration
                Treatment with a semi-hard collar and taking rest for three to six weeks; 12 twice weekly sessions of physiotherapy and home exercises for six weeks; or continuation of daily activities as much as possible without specific treatment (control group).
                Time course of changes in pain scores for arm and neck pain on a 100 mm visual analogue scale and in the neck disability index during the first six weeks.
                In the wait and see group, arm pain diminished by 3 mm/week on the visual analogue scale (beta=-3.1 mm, 95% confidence interval -4.0 to -2.2 mm) and by 19 mm in total over six weeks. Patients who were treated with cervical collar or physiotherapy achieved additional pain reduction (collar: beta=-1.9 mm, -3.3 to -0.5 mm; physiotherapy: beta=-1.9, -3.3 to -0.8), resulting in an extra pain reduction compared with the control group of 12 mm after six weeks. In the wait and see group, neck pain did not decrease significantly in the first six weeks (beta=-0.9 mm, -2.0 to 0.3). Treatment with the collar resulted in a weekly reduction on the visual analogue scale of 2.8 mm (-4.2 to -1.3), amounting to 17 mm in six weeks, whereas physiotherapy gave a weekly reduction of 2.4 mm (-3.9 to -0.8) resulting in a decrease of 14 mm after six weeks. Compared with a wait and see policy, the neck disability index showed a significant change with the use of the collar and rest (beta=-0.9 mm, -1.6 to -0.1) and a non-significant effect with physiotherapy and home exercises.
                A semi-hard cervical collar and rest for three to six weeks or physiotherapy accompanied by home exercises for six weeks reduced neck and arm pain substantially compared with a wait and see policy in the early phase of cervical radiculopathy. Trial registration Clinical trials NCT00129714. A variety of bone graft substitutes, interbody cages, and anterior plates have been used in cervical interbody fusion, but no controlled study was conducted on the clinical performance of beta-tricalcium phosphate (beta-TCP) and the effect of supplemented anterior plate fixation. The objective of this prospective, randomized clinical study was to evaluate the effectiveness of implanting interbody fusion cage containing beta-TCP for the treatment of cervical radiculopathy and/or myelopathy, and the fusion rates and outcomes in patients with or without randomly assigned plate fixation. Sixty-two patients with cervical radiculopathy and/or myelopathy due to soft disc herniation or spondylosis were treated with one- or two-level discectomy and fusion with interbody cages containing beta-TCP. They were randomly assigned to receive supplemented anterior plate (n = 33) or not (n = 29). The patients were followed up for 2 years postoperatively. The radiological and clinical outcomes were assessed during a 2-year follow-up. The results showed that the fusion rate (75.0%) 3 months after surgery in patients treated without anterior cervical plating was significantly lower than that (97.9%) with plate fixation (P < 0.05), but successful bone fusion was achieved in all patients of both groups at 6-month follow-up assessment. Patients treated without anterior plate fixation had 11 of 52 (19.2%) cage subsidence at last follow-up. No difference (P > 0.05) was found regarding improvement in spinal curvature as well as neck and arm pain, and recovery rate of JOA score at all time intervals between the two groups. Based on the findings of this study, interbody fusion cage containing beta-TCP following one- or two-level discectomy proved to be an effective treatment for cervical spondylotic radiculopathy and/or myelopathy. Supplemented anterior plate fixation can promote interbody fusion and prevent cage subsidence but do not improve the 2-year outcome when compared with those treated without anterior plate fixation. A prospective randomized clinical study.
                To compare 2 surgical methods in the treatment of cervical radiculopathy caused by hard or soft disc herniation; namely, simple discectomy versus discectomy with an additional interbody fusion with a Ray titanium cage.
                Although an interbody fusion after anterior decompressive surgery for hard or soft disc herniation is widely accepted, there is no scientific evidence that convincingly demonstrates that insertion of graft material for interbody fusion is necessary after discectomy and decompression of the nervous elements have been performed. To date, no randomized studies have compared simple discectomy with discectomy followed by an interbody fusion with a titanium cage.
                Eighty-six patients with symptoms of nerve root compression at 1 level were randomly allocated to either discectomy followed by fusion with a Ray titanium cage (40 patients) or to discectomy alone (46 patients). Clinical and radiologic follow-up was performed 3, 12, and 24 months after surgery.
                There was no statistically significant difference between the 2 groups concerning self-reported satisfaction or severity of pain in the neck and arm. Two years after the operation, 86.1% of the patients treated with cage stated a good outcome versus 76.7% in the discectomy group (P = 0.44). The rate of fusion was 83.3% in the cage group versus 81.0% in the discectomy group (P = 0.30). Furthermore, after 2 years, also the rates of new adjacent disc degeneration or spondylosis were the same in both groups.
                This study showed no statistically significant difference between simple discectomy and discectomy followed by interbody fusion with a titanium cage in the surgical treatment of cervical radiculopathy caused by disc herniation. The need for interbody fusion after anterior cervical discectomy for radiculopathy remains controversial. The purpose of this study was to assess clinical and radiographic outcomes in patients with cervical radiculopathy after discectomy without fusion (ACD), discectomy with intervertebral fusion (ACDF), and discectomy with intervertebral fusion and instrumentation (ACDFI).
                Forty-two consecutive patients with cervical radiculopathy who failed medical management were randomized to one of three treatment groups: ACD, ACDF, or ACDFI. Indices including symptoms, work status, Short Form-36, McGill pain scores, and anteroposterior/lateral flexion/extension x-rays were obtained preoperatively and during the follow-up period.
                There were no inter-group differences observed during the 2-year follow-up period with respect to neck pain, interscapular pain, or arm pain (P > 0.05). Short Form-36 scores demonstrated a dramatic postoperative improvement followed by further gradual improvement in both physical and mental components as well as other subscale scores in all groups during the follow-up period (P < 0.05). Fusion occurred in 67% of the ACD patients compared with 93% of the ACDF patients and 100% of the ACDFI patients (P < 0.05). Segmental kyphosis was noted in 75% of the ACD patients postoperatively compared with 17% preoperatively. There was no change in sagittal balance in the ACDF or ACDFI groups (P > 0.05).
                Patient selection and surgical decompression remain the key to achieving desirable clinical outcomes after cervical discectomy for radiculopathy. Within a 2-year follow-up period, the technique of reconstruction plays no role in clinical results. However, ACD alone results in segmental kyphosis compared with ACDF and ACDFI. Forty-six consecutive patients with neck pain and arm radiculopathy were treated with anterior cervical discectomy and fusion. All patients had neurological symptoms corresponding to a herniated disc and/or spondylosis at one or two cervical levels, verified by magnetic resonance imaging. The patients were stabilized with an anterior graft and randomized to either fixation with a CSLP plate or no internal fixation. Preoperatively and 2 years postoperatively the patients filled in a questionnaire that included a modified Million Index, a modified Oswestry Index and the Zung Depression Scale. They were also asked to register their pain in the arm and in the neck on a vertical visual analogue scale (VAS). At the 2-year follow-up, an unbiased observer graded the patients' clinical outcome using Odom's criteria. A test-retest procedure was carried out to examine the questionnaire reproducibility. In the group that was operated at one level, there was no significant improvement in any of the scores. Nevertheless, 81% of the patients were satisfied with the outcome of the surgery. All scores improved in the group operated at two levels. The pain in the neck and arm, as measured on a VAS, decreased in both groups. The improvement in arm pain was significantly more pronounced in patients operated with a plate at two levels compared to those who were operated without a plate. At the 2-year follow-up, patients with an excellent or good result according to Odom's criteria had a lower Million Index (P < 0.0005), Oswestry Index (P < 0.0005), and Zung (P = 0.024) score, than the group classified as fair or poor. There was a significant correlation (P < 0.0001 for all scores) between the test and retest results. We conclude that the modified Million Index and Oswestry Index are clinically useful tools in the evaluation of outcome after degenerative cervical disc surgery. The clinical benefits of plate fixation were minimal. The outcome after surgery, measured with the Oswestry Index, Million Index and VAS for arm and neck pain, seems to correlate well with the classification of outcome by Odom. 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.
                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.
                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).
                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. Although good surgical technique is effective in reducing postoperative epidural fibrosis, compression or tethering of the nerve root may cause recurrent radicular pain and physical impairment. The implantation of a bioresorbable gel on the dura may further decrease the amount of scar formation after surgery and thus improve the patient's ability to perform activities of daily living (ADL). This study is a 12-month evaluation of the safety and effectiveness of Oxiplex/SP Gel (FzioMed, Inc., San Luis Obispo, CA) in the reduction of pain and radiculopathy after lumbar discectomy.
                A pilot randomized single-blind multicenter clinical trial was conducted to evaluate the performance of Oxiplex/SP Gel in patients who underwent surgery for unilateral herniation of the lumbar disc at L4-5 or L5-S1. Eighteen patients with severe leg pain and lower-extremity weakness (11 women and seven men) were randomly assigned intraoperatively to receive the gel at the conclusion of surgery (treatment group) or to undergo surgery alone (control group). Self-assessment questionnaires (Lumbar Spine Outcomes Questionnaire) to assess pain, symptoms, and ADL were completed preoperatively and at scheduled postoperative intervals (30 days, 90 days, 6 months, and 12 months). The authors examined the spine and lower extremities of patients scheduled for discectomy to assess neurological function and pain. Treated patients received sufficient Oxiplex/SP Gel (1-3 ml) to coat the nerve root and fill the epidural space. Postoperative clinical evaluations were performed at 30 and 90 days. Patients completed the self-assessment questionnaires at baseline and were contacted by telephone or mail for the completion of the postoperative self-assessment questionnaires. Surgical procedures were well tolerated; no device-related adverse events and no clinically significant laboratory results were reported. The 11 patients with severe leg pain and lower-extremity weakness who were treated with Oxiplex/SP Gel had a reduction in those symptoms at 30 days, 90 days, 6 months, and 12 months after discectomy, compared with the seven control patients who underwent surgery only.
                Oxiplex/SP Gel was easy to use and safe in patients who underwent unilateral discectomy. A greater benefit in clinical outcome measures was seen over the 12-month follow-up period in gel-treated patients. The purpose of the study was to evaluate whether a microsurgical discectomy (MS), compared with a standard lumbar discectomy (SD), could reduce the stay at the hospital or the postoperative morbidity. The study was prospective and of 79 patients with "virgin' lumbar radiculopathy from only one nerve root, 39 were randomized to MS and 40 to SD. All patients had positive myelography or CT findings. The fascia incision was 31 and 70 mm (p < 0.0001), respectively, but the skin incision was of the same length in both groups to blind the study. For the MS and SD group of patients, the median operation time was 48 and 35 min (p < 0.0001), and the stay at the hospital was 5.2 and 4.6 days, respectively. The two groups were not different in sex, age, localization or type of herniated discs. Use of analgesic medicine and the presence of pain in the back or legs pre- and postoperative was the same. We conclude that in a controlled and prospective study, reducing the fascia incision and the muscular dissection from a median of 70-31 mm, does not shorten the length of a stay at a hospital and it has no influence on postoperative morbidity.
Both small trials had significant risks of bias and do not provide reliable evidence on the effects of surgery for cervical spondylotic radiculopathy or myelopathy. It is unclear whether the short-term risks of surgery are offset by long-term benefits. Further research is very likely to have an impact on the estimate of effect and our confidence in it.
There is low quality evidence that surgery may provide pain relief faster than physiotherapy or hard collar immobilization in patients with cervical radiculopathy; but there is little or no difference in the long-term.
There is very low quality evidence that patients with mild myelopathy feel subjectively better shortly after surgery, but there is little or no difference in the long-term.