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Peter C. Gerszten

Clinical practice guidelines may be defined as systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical conditions. The practice guideline is a management plan that enables healthcare providers to make sequential decisions about testing or therapy in a given clinical situation. Given the heterogeneity of disease presentations and the complexity of making therapeutic decisions, the development of guidelines in neurosurgery presents unique problems and challenges. Clinical practice guidelines were developed in part as a method for the assessment of quality of medical care processes. Practice guidelines serve as a tool for comparisons to be made within and between healthcare delivery systems. The implementation of guidelines also allows for the acquisition of clinical and financial data that provide for outcomes analysis and other types of information. The characterization of patterns of care in different institutions and the relationship between patterns of care and outcomes will in the future allow for quality improvement, enable physicians to offer predictability and accountability to third-party interests, and contribute to an understanding of how to offer the best care to neurosurgical patients.

The author provides an overview of clinical practice guidelines and illustrates their role in the assessment of quality of patient care, demonstrates how they fit into the methodology of quality assessments, and underscores the importances of practice quidelines for the development of disease management systems.

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William C. Welch and Peter C. Gerszten

In recent years the general trend in spinal surgery has been one of reductionism and minimalization. A number of techniques have recently been developed that are applicable in the treatment of lumbar disc herniation and discogenic pain due to degenerative disc disease. The purpose of this manuscript is to examine two newer percutaneous disc treatment techniques, intradiscal electrothermal therapy (IDET) anuloplasty and nucleoplasty. The authors review the appropriate clinical treatment criteria, techniques, and lessons learned after performing these procedures in more than 100 patients.

The IDET involves the percutaneous insertion of a specially designed thermal resistance probe followed by controlled heating of the intervertebral disc. This may result in disc shrinkage and reduction in pain. The nucleoplasty procedure involves the percutaneous removal of disc material by using a low-temperature resister probe to disintegrate and evacuate disc material, followed by thermal treatment of adjacent residual disc material. To date, no study has been published in which investigators examine the outcomes of this procedure for the treatment of radicular leg pain and low-back pain.

Both IDET and nucleoplasty appear to be safe procedures. The IDET procedure may be an alternative to lumbar interbody fusion. Although its long-term role is being defined, this technique appears to provide intermediate-term relief of pain in a population of patients with discogenic low-back pain. Nucleoplasty may provide a percutaneous alternative to microdiscectomy in selected cases.

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Peter C. Gerszten and William C. Welch

✓Percutaneous balloon kyphoplasty has become a widely adopted treatment option for patients with pain due to pathological compression fractures. One potential risk of the procedure is the displacement of tumor into the spinal canal and resulting spinal cord or cauda equina injury during inflation of the balloon prior to polymethylmethacrylate (PMMA) placement. In addition, the presence of any remaining tumor between the PMMA and the fractured cortical bone can lead to suboptimal improvement in stabilization and subsequent pain relief. The authors describe a technique to remove tumor from within the vertebral body (VB) through a percutaneous working channel prior to kyphoplasty balloon inflation and augmentation.

The technique was successfully used in all three patients who had presented with pain, and the pain improved in all three cases. There was no extravasation of PMMA into the spinal canal in any case.

A combined VB tumor debulking and kyphoplasty technique offers the ability to improve the placement of PMMA within the diseased vertebral body, potentially leading to increased safety as well as clinical effectiveness for stabilization of these fractures.

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Peter C. Gerszten, A. Leland Albright and Graham F. Johnstone

Intrathecal baclofen infusion (IBI) is an effective treatment for spasticity secondary to cerebral palsy (CP). The authors retrospectively reviewed the need for orthopedic surgery of the lower extremities in 48 patients with spastic CP who were treated with IBI. Forty pumps were placed in patients suffering from spastic quadriplegia (84%) and eight (16%) in patients with spastic diplegia. The patients' ages ranged from 5 to 43 years (mean 15 years). The mean follow-up period was 53 months (range 22-94 months). The mean baclofen dosage was 306 μg/day (range 25-1350 μg/day). At the time of pump placement, subsequent orthopedic surgery was planned in 28 patients (58%); however, only 10 (21%) underwent orthopedic surgery after IBI therapy. In all 10 cases, the surgical procedure was planned at the time of initial evaluation for IBI therapy. In the remaining 18 patients, who did not subsequently undergo their planned orthopedic operation, it was believed that their lower-extremity spasticity had improved to the degree that orthopedic intervention was no longer indicated. In addition, although six patients had undergone multiple orthopedic operations before their spasticity was treated, no patient required more than one orthopedic operation after IBI treatment for their spasticity. The authors conclude that IBI for treatment of spastic CP reduces the need for subsequent orthopedic surgery for the effects of lower-extremity spasticity. In patients with spastic CP and lower-extremity contractures, spasticity should be treated before orthopedic procedures are performed.

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Peter C. Gerszten and Edward A. Monaco III

Object

Patients with symptomatic pathological compression fractures require spinal stabilization surgery for mechanical back pain control and radiation therapy for the underlying malignant process. Spinal radiosurgery provides excellent long-term radiographic control for vertebral metastases. Percutaneous cement augmentation using polymethylmethacrylate (PMMA) may be contraindicated in lesions with spinal canal compromise due to the risk of displacement of tumor resulting in spinal cord or cauda equina injury. However, there is also significant morbidity associated with open corpectomy procedures in patients with metastatic cancer, especially in those who subsequently require adjuvant radiotherapy. This study evaluated a treatment paradigm for malignant vertebral compression fractures consisting of transpedicular coblation corpectomy combined with closed fracture reduction and fixation, followed by spinal radiosurgery.

Methods

Eleven patients (6 men and 5 women, mean age 58 years) with symptomatic vertebral body metastatic tumors associated with moderate spinal canal compromise were included in this study (8 thoracic levels, 3 lumbar levels). Primary histologies included 4 lung, 2 breast, 2 renal, and 1 each of thyroid, bladder, and hepatocellular carcinomas. All patients underwent percutaneous transpedicular coblation corpectomy immediately followed by balloon kyphoplasty through the same 8-gauge cannula under fluoroscopic guidance. Patients subsequently underwent radiosurgery to the affected vertebral body (mean time to treatment 14 days). Postoperatively, patients were assessed for pain reduction and neurological morbidity.

Results

There were no complications associated with any part of the procedure. Adequate cement augmentation within the vertebral body was achieved in all cases. The mean radiosurgical tumor dose was 19 Gy covering the entire vertebral body. The procedure provided long-term pain improvement and radiographic tumor control in all patients (follow-up range 7–44 months). No patient later required open surgery. No radiation-induced toxicity or new neurological deficit occurred during the follow-up period.

Conclusions

This treatment paradigm for pathological fractures of percutaneous transpedicular corpectomy combined with cement augmentation followed by radiosurgery was found to be safe and clinically effective. This technique combines minimally invasive procedures that avoid the morbidity associated with open surgery while providing spinal canal decompression and immediate fracture stabilization, and then administering a single-fraction tumoricidal radiation dose.

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Mark H. Bilsky, Steven D. Chang, Peter C. Gerszten and Steven Kalkanis

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Peter C. Gerszten, A. Leland Albright and Graham F. Johnstone

Intrathecal baclofen infusion (IBI) is an effective treatment for spasticity secondary to cerebral palsy (CP).

Object. To assess the need for orthopedic surgery of the lower extremities in such cases, the authors retrospectively reviewed the outcome in 48 patients with spastic CP who were treated with IBI.

Methods. Pumps were placed in 40 patients (84%) suffering from spastic quadriplegia and eight patients (16%) with spastic diplegia. The patients' ages ranged from 5 to 43 years (mean 15 years). The mean follow-up period was 53 months (range 24–94 months). The mean baclofen dosage was 306 µg/day (range 25–1350 µg/day). At the time of pump placement, subsequent orthopedic surgery was planned in 28 patients (58%); however, only 10 (21%) underwent surgery after IBI therapy. In all 10 cases, the surgical procedure was planned at the time of initial evaluation for IBI therapy. In the remaining 18 patients, who did not subsequently undergo their planned orthopedic operation, it was believed that their lower-extremity spasticity had improved to the degree that intervention was no longer indicated. In addition, although six patients had undergone multiple orthopedic operations before their spasticity was treated, no patient required more than one operation after IBI treatment for spasticity.

Conclusions. The authors conclude that IBI for treatment of spastic CP reduces the need for subsequent orthopedic surgery for the effects of lower-extremity spasticity. In patients with spastic CP and lower-extremity contractures, spasticity should be treated before orthopedic procedures are performed.

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Hazem Mashaly, Erin E. Paschel, Nicolas K. Khattar, Ezequiel Goldschmidt and Peter C. Gerszten

OBJECTIVE

The development of symptomatic adjacent-segment disease (ASD) is a well-recognized consequence of lumbar fusion surgery. Extension of a fusion to a diseased segment may only lead to subsequent adjacent-segment degeneration. The authors report the use of a novel technique that uses dynamic stabilization instead of arthrodesis for the surgical treatment of symptomatic ASD following a prior lumbar instrumented fusion.

METHODS

A cohort of 28 consecutive patients was evaluated who developed symptomatic stenosis immediately adjacent to a previous lumbar instrumented fusion. All patients had symptoms of neurogenic claudication refractory to nonsurgical treatment and were surgically treated with decompression and dynamic stabilization instead of extending the fusion construct using a posterior lumbar dynamic stabilization system. Preoperative symptoms, visual analog scale (VAS) pain scores, and perioperative complications were recorded. Clinical outcome was gauged by comparing VAS scores prior to surgery and at the time of last follow-up.

RESULTS

The mean follow-up duration was 52 months (range 17–94 months). The mean interval from the time of primary fusion surgery to the dynamic stabilization surgery was 40 months (range 10–96 months). The mean patient age was 51 years (range 29–76 years). There were 19 (68%) men and 9 (32%) women. Twenty-three patients (82%) presented with low-back pain at time of surgery, whereas 24 patients (86%) presented with lower-extremity symptoms only. Twenty-four patients (86%) underwent operations that were performed using single-level dynamic stabilization, 3 patients (11%) were treated at 2 levels, and 1 patient underwent 3-level decompression and dynamic stabilization. The most commonly affected and treated level (46%) was L3–4. The mean preoperative VAS pain score was 8, whereas the mean postoperative score was 3. No patient required surgery for symptomatic degeneration rostral to the level of dynamic stabilization during the follow-up period.

CONCLUSIONS

The use of posterior lumbar dynamic stabilization may offer a valid and safe option for the management of patients who develop ASD rostral to a previously instrumented arthrodesis. The technique may serve as an alternative to multilevel arthrodesis in this patient population. By implanting a dynamic stabilization device instead of an extension of a rigid construct, this might translate into a reduction in the development of yet another level of ASD.

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Peter C. Gerszten, John J. Moossy, John C. Flickinger and William C. Welch

Object. The authors of clinical studies have demonstrated a significant association between the presence of extensive post—lumbar discectomy peridural scar formation and the recurrence of low-back and radicular pain. Low-dose perioperative radiotherapy has been demonstrated to inhibit peridural fibrosis after laminectomy in animal models. The present study was designed to evaluate the clinical efficacy of preoperative irradiation in patients with failed—back surgery syndrome due to peridural fibrosis who underwent reexploration and nerve root decompression.

Methods. Ten patients with symptomatic post—discectomy peridural fibrosis were randomized. Half of the patients underwent 700-cGy external-beam irradiation to the operative site 24 hours prior to reexploration and decompressive treatment of their symptomatic nerve root(s) (treatment group) and the other half underwent reexploration and decompressive treatment without preoperative irradiation (control group). All patients underwent simulated irradiation so neither patient nor surgeon was aware of the patient's group. In all patients the antiadhesion product ADCON-L was placed over the affected nerve root at the time of surgery. Clinical outcome was assessed using the American Association of Neurological Surgeons/Congress of Neurological Surgeons Joint Section Lumbar Disc Herniation Study Questionnaire at baseline, 6 weeks, 3 months, and 1 year follow up.

Five men and five women (mean age 42 years) underwent randomization and surgery. Three patients underwent reexploration at L4–5, four at L5—S1, and three at both levels. No complication was associated with irradiation, and no new neurological deficits occurred. At 1-year follow-up examination, three irradiation-treated patients were pain free and two experienced improvement. In the control group, three patients experienced improved pain relief and two were unchanged. There was a trend toward better outcome at 1 year in the radiotherapy-treated group (p = 0.056).

Conclusions. Preoperative low-dose external-beam irradiation improved clinical outcomes after reexploration and decompression of nerve roots affected by postlaminectomy peridural fibrosis causing radicular pain. The addition of preoperative irradiation may improve outcome in patients who undergo reoperation for recurrent radicular pain associated with a significant amount of peridural fibrosis, particularly now that no antiadhesion product is available for clinical use.

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Matthew B. Maserati, Matthew J. Tormenti, David M. Panczykowski, Christopher M. Bonfield and Peter C. Gerszten

Object

The authors report the use and preliminary results of a novel hybrid dynamic stabilization and fusion construct for the surgical treatment of degenerative lumbar spine pathology.

Methods

The authors performed a retrospective chart review of all patients who underwent posterior lumbar instrumentation with the Dynesys-to-Optima (DTO) hybrid dynamic stabilization and fusion system. Preoperative symptoms, visual analog scale (VAS) pain scores, perioperative complications, and the need for subsequent revision surgery were recorded. Each patient was then contacted via telephone to determine current symptoms and VAS score. Follow-up was available for 22 of 24 patients, and the follow-up period ranged from 1 to 22 months. Clinical outcome was gauged by comparing VAS scores prior to surgery and at the time of telephone interview.

Results

A total of 24 consecutive patients underwent lumbar arthrodesis surgery in which the hybrid system was used for adjacent-level dynamic stabilization. The mean preoperative VAS score was 8.8, whereas the mean postoperative VAS score was 5.3. There were five perioperative complications that included 2 durotomies and 2 wound infections. In addition, 1 patient had a symptomatic medially placed pedicle screw that required revision. These complications were not thought to be specific to the DTO system itself. In 3 patients treatment failed, with treatment failure being defined as persistent preoperative symptoms requiring reoperation.

Conclusions

The DTO system represents a novel hybrid dynamic stabilization and fusion construct. The technique holds promise as an alternative to multilevel lumbar arthrodesis while potentially decreasing the risk of adjacent-segment disease following lumbar arthrodesis. The technology is still in its infancy and therefore follow-up, when available, remains short. The authors report their preliminary experience using a hybrid system in 24 patients, along with short-interval clinical and radiographic follow-up.