Tag: randomized

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A 5- to 8-year randomized study on the treatment of cervical radiculopathy: anterior cervical decompression and fusion plus physiotherapy versus physiotherapy alone

Journal of Neurosurgery: Spine 26(1):19-27

The aim of this study was to evaluate the 5- to 8-year outcome of anterior cervical decompression and fusion (ACDF) combined with a structured physiotherapy program as compared with that following the same physiotherapy program alone in patients with cervical radiculopathy. No previous prospective randomized studies with a follow-up of more than 2 years have compared outcomes of surgical versus nonsurgical intervention for cervical radiculopathy.

METHODS: Fifty-nine patients were randomized to ACDF surgery with postoperative physiotherapy (30 patients) or to structured physiotherapy alone (29 patients). The physiotherapy program included general and specific exercises as well as pain coping strategies. Outcome measures included neck disability (Neck Disability Index [NDI]), neck and arm pain intensity (visual analog scale [VAS]), health state (EQ-5D questionnaire), and a patient global assessment. Patients were followed up for 5–8 years.

RESULTS: After 5–8 years, the NDI was reduced by a mean score% of 21 (95% CI 14–28) in the surgical group and 11% (95% CI 4%–18%) in the nonsurgical group (p = 0.03). Neck pain was reduced by a mean score of 39 mm (95% CI 26–53 mm) compared with 19 mm (95% CI 7–30 mm; p = 0.01), and arm pain was reduced by a mean score of 33 mm (95% CI 18–49 mm) compared with 19 mm (95% CI 7–32 mm; p = 0.1), respectively. The EQ-5D had a mean respective increase of 0.29 (95% CI 0.13–0.45) compared with 0.14 (95% CI 0.01–0.27; p = 0.12). Ninety-three percent of patients in the surgical group rated their symptoms as “better” or “much better” compared with 62% in the nonsurgical group (p = 0.005). Both treatment groups experienced significant improvement over baseline for all outcome measures.

CONCLUSIONS: In this prospective randomized study of 5- to 8-year outcomes of surgical versus nonsurgical treatment in patients with cervical radiculopathy, ACDF combined with physiotherapy reduced neck disability and neck pain more effectively than physiotherapy alone. Self-rating by patients as regards treatment outcome was also superior in the surgery group. No significant differences were seen between the 2 patient groups as regards arm pain and health outcome.

 

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Utility of Ictal Single Photon Emission Computed Tomography in Mesial Temporal Lobe Epilepsy With Hippocampal Atrophy: A Randomized Trial

Neurosurgery 68:431–436, 2011 DOI: 10.1227/NEU.0b013e318201c293

The development of newer diagnostic technologies has reduced the need for invasive electroencephalographic (EEG) studies in identifying the epileptogenic zone, especially in adult patients with mesial temporal lobe epilepsy and hippocampal sclerosis (MTLE-HS).

OBJECTIVE: To evaluate ictal single photon emission computed tomography (SPECT) in the evaluation and treatment of patients with MTLE-HS.

METHODS: MTLE patients were randomly assigned to those with (SPECT, n = 124) and without ictal SPECT (non-SPECT, n = 116) in an intent-to-treat protocol. Primary end points were the proportion of patients with invasive EEG studies, and those offered surgery. Secondary end points were the length of hospital stay and the proportion of patients with secondarily generalized seizures (SGS) during video-EEG, postsurgical seizure outcome, and hospital cost.

RESULTS: The proportion of patients offered surgery was similar in the SPECT (85%) and non-SPECT groups (81%), as well as the proportion that had invasive EEG studies (27% vs 23%). The mean duration of hospital stay was 1 day longer for the SPECT group (P , 0.001). SGS occurred in 51% of the SPECT and 26% of the non-SPECT group (P , 0.001). The cost of the presurgical evaluation was 35% higher for the SPECT compared with the non-SPECT group (P , 0.001). The proportion of patients seizure-free after surgery was similar in the SPECT (59%) compared with non-SPECT group (54%).

CONCLUSION: Ictal-SPECT did not add localizing value beyond what was provided by EEG-video telemetry and structural MRI that altered the surgical decision and outcome for MTLE-HS patients. Ictal-SPECT increased hospital stay was associated with increased costs and a higher chance of SGS during video-EEG monitoring. These findings support the notion that a protocol including ictal SPECT is equivalent to one without SPECT in the presurgical evaluation of adult patients with MTLE-HS.

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Clinical Outcomes of Bryan Cervical Disc Arthroplasty A Prospective, Randomized, Controlled, Single Site Trial With 48-Month Follow-up

J Spinal Disord Tech 2010;23:367–371

Study Design: Prospective, randomized, controlled. Level 1 evidence.

Objective: To report functional outcomes at 48 months followup on prospectively randomized patients to either the Bryan cervical disc prosthesis or anterior cervical discectomy and fusion (ACDF) at a single site.

Summary of Background Data: Surgical treatment of cervical disc pathology can involve discectomy and fusion (ACDF), the gold standard technique. The safety and effectiveness of this procedure has been established and demonstrated in the literature, however, limitations have evolved and alternatives such as disc replacement are being investigated. Intervertebral disc replacement is designed to preserve motion, both at affected and adjacent levels avoiding limitations of fusion such as adjacent level degeneration. New onset degenerative changes and possible recurring neurologic symptoms may be deferred or eliminated with cervical disc replacement. A recent multicenter trial with 24 months follow-up has shown the Bryan disc to compare favorably with ACDF. Continued follow-up is needed to further evaluate and compare functional outcomes in both these cohorts.

Methods: A total of 47 patients were enrolled at our site as part of an ongoing multicenter prospectively randomized study investigating ACDF versus Bryan cervical disc prosthesis. Functional outcomes are now reported at 48 months follow-up for our cohort of participants. Neck disability index score (NDI), VAS neck and arm and SF-36 both physical and mental as well as complications and reoperations will be reported.

Results: Functional outcome data collected at routine follow-up for 48-months has favorably demonstrated improved functional outcomes for NDI, neck/arm pain VAS scores, and the SF-36 physical/mental health component scores for the Bryan arthroplasty and ACDF cohorts. The NDI scores for the Bryan arthroplasty preoperatively was 51 and at 48 months 10. For ACDF preoperative NDI score was also 51 and at 48 months 16.7. At 48 months NDI success, measured by Z15 points NDI improvement demonstrated a 93.3% success for Bryan arthroplasty and an 82.4%success for ACDF. VAS neck pain scores for the Bryan arthroplasty preoperatively was 76.2 and at 48 months was 13.6. VAS neck pain scores for ACDF preoperatively was 80.6 and at 48 months was 28.1. Arm Pain scores were also measured and for the Bryan arthroplasty preoperatively measured 78.8 and at 48 months 10.8. For ACDF arm pain scores preoperatively measured 77.1 and at 48 months 21.7. These outcomes have not been associated with any degradation of outcome measures from 2 to 4 years. During the 48 months of follow-up at our institution we also report 6 secondary surgeries in our control group (ACDF) and only 1 in our investigational group (Bryan). Of the 6 surgeries in the control group performed, 3 or 12% to date were for adjacent level degenerative disease and 1 or 4% for remote level degenerative disc disease. The remaining 2 surgeries were performed on the same patient for a pseudarthrosis. In the investigational group there was only 1 secondary surgery performed to date for adjacent level disease 5%.

Conclusions: At 48 months, cervical arthroplasty with the Bryan cervical disc prosthesis continues to compare favorably to ACDF at our institution. There has been no degradation of functional outcomes from 24 to 48 months for NDI, VAS of neck and arm, and SF-36. There has been a lower incidence of secondary surgeries for the Bryan arthroplasty cohort to date.

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