Study design Literature review Objectives To describe new treatments for painful osteoporotic compression fractures in light of available scientific literature and clinical experience Summary of background data Painful vertebral osteoporotic compression fractures lead to significant morbidity and mortality This relates to pulmonary dysfunction, eating disorders (nutritional deficits), pain, loss of independence, and mental status change (related to pain and medications) Medications to treat osteoporosis (primarily antiresorptive) do not effectively treat the pain or the fracture, and require over 1 year to reduce the degree of osteoporosis Kyphoplasty and vertebroplasty are new techniques that help decrease the pain and improve function in fractured vertebrae Methods This is a descriptive review of the background leading to vertebroplasty and kyphoplasty, a description of the techniques, a review of the literature, as well as current ongoing studies evaluating kyphoplasty Results Both techniques have had a very high acceptance and use rate There is 95% improvement in pain and significant improvement in function following treatment by either of these percutaneous techniques Kyphoplasty improves height of the fractured vertebra, and improves kyphosis by over 50%, if performed within 3 months from the onset of the fracture (onset of pain) There is some height improvement, though not as marked, along with 95% clinical improvement, if the procedure is performed after 3 months Complications occur with both and relate to cement leakage in both, and cement emboli with vertebroplasty Conclusion Kyphoplasty and vertebroplasty are safe and effective, and have a useful role in the treatment of painful osteoporotic vertebral compression fractures that do not respond to conventional treatments Kyphoplasty offers the additional advantage of realigning the spinal column and regaining height of the fractured vertebra, which may help decrease the pulmonary, GI, and early morbidity consequences related to these fractures Both procedures are technically demanding

New technologies in spine: kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures.

Study Design. An Institutional Review Board-approved Phase I efficacy study of inflatable bone tamp usage in the treatment of symptomatic osteoporotic compression fractures. Objectives. To evaluate the safety and efficacy of inflatable bone tamp reduction and cement augmentation, kyphoplasty, in the treatment of painful osteoporotic vertebral compression fractures. Summary of Background Data. Osteoporotic compression fractures can result in progressive kyphosis and chronic pain. Traditional treatment for these patients includes bed rest, analgesics, and bracing. Augmentation of vertebral compression fractures with polymethylmethacryiate, vertebroplasty, has been used to treat pain. This technique, however, makes no attempt to restore the height of the collapsed vertebral body. Kyphoplasty is a new technique that involves the introduction of inflatable bone tamps into the vertebral body. Once inflated, the bone tamps restore the vertebral body back toward its original height while creating a cavity that can be filled with bone cement. Patients and Methods. Seventy consecutive kyphoplasty procedures were performed in 30 patients. The indications included painful primary or secondary osteoporotic vertebral compression fractures. Mean duration of symptoms was 5.9 months. Symptomatic levels were identified by correlating the clinical data with MRI findings. Perioperative variables and bone tamp complications or issues were recorded and analyzed. Preoperative and postoperative radiographs were compared to calculate the percentage height restored. Outcome data were obtained by comparing preoperative and latest postoperative SF-36 data. Results. At the completion of the Phase I study there were no major complications related directly to use of this technique or use of the inflatable bone tamp. In 70% of the vertebral bodies kyphoplasty restored 47% of the lost height. Cement leakage occurred at six levels (8.6%). SF-36 scores for Bodily Pain 11.6-58.7, (P = 0.0001) and Physical Function 11.7-47.4, (P = 0.002) were among those that showed significant improvement. Conclusions. The inflatable bone tamp was efficacious in the treatment of osteoporotic vertebral compression fractures. Kyphoplasty is associated with early clinical improvement of pain and function as well as restoration of vertebral body height in the treatment of painful ostecporotic compression fractures.

Initial outcome and efficacy of kyphoplasty in the treatment of painful osteoporotic vertebral compression fractures

STUDY DESIGN: Systematic literature review. OBJECTIVE: To evaluate the safety and efficacy of vertebroplasty and kyphoplasty using the data presented in published clinical studies, with respect to patient pain relief, restoration of mobility and vertebral body height, complication rate, and incidence of new adjacent vertebral fractures. SUMMARY OF BACKGROUND DATA: Vertebroplasty and kyphoplasty have been gaining popularity for treating vertebral fractures. Current reviews provide an overview of the procedures but are not comprehensive and tend to rely heavily on personal experience. This article aimed to compile all available data and evaluate the clinical outcome of the 2 procedures. METHODS: This is a systematic review of all the available data presented in peer-reviewed published clinical trials. The methodological quality of included studies was evaluated, and data were collected targeting specific standard measurements. Where possible, a quantitative aggregation of the data was performed. RESULTS: A large proportion of subjects had some pain relief, including 87% with vertebroplasty and 92% with kyphoplasty. Vertebral height restoration was possible using kyphoplasty (average 6.6 degrees ) and for a subset of patients using vertebroplasty (average 6.6 degrees ). Cement leaks occurred for 41% and 9% of treated vertebrae for vertebroplasty and kyphoplasty, respectively. New fractures of adjacent vertebrae occurred for both procedures at rates that are higher than the general osteoporotic population but approximately equivalent to the general osteoporotic population that had a previous vertebral fracture. CONCLUSIONS: The problem with stating definitely that vertebroplasty and kyphoplasty are safe and effective procedures is the lack of comparative, blinded, randomized clinical trials. Standardized evaluative methods should be adopted.

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Vertebroplasty and kyphoplasty: a systematic review of 69 clinical studies.

Introduction Vertebroplasty and kyphoplasty have been gaining popularity for treating vertebral fractures Current reviews provide an overview of the procedures but are not comprehensive and tend to rely heavily on personal experience This paper aimed to compile all available data and evaluate the clinical outcome of the two procedures The objective was to evaluate the safety and efficacy of vertebroplasty and kyphoplasty using the data presented in published clinical studies, with respect to patient pain relief, restoration of mobility and vertebral body height, complication rate, and incidence of new adjacent vertebral fractures Methods This is a systematic review of all the available data presented in peer reviewed published clinical trials (69 papers) Where possible a quantitative aggregation of the data was performed Data was collected for each study under the headings: general information, participants, intervention, outcomes, complications, and follow-up Outcome data was collected detailing: pain relief, general health, functional improvements, satisfaction with treatment, and reduction in kyphosis Complications included: cement leakage (asymptomatic and symptomatic), neurological deficits, cardiovascular, pulmonary and any other clinically relevant complication Long term follow-up information included all the items recorded under the heading “outcome” with the addition of new fracture details Results A large proportion of subjects experienced some pain relief (87% vertebroplasty, 92% kyphoplasty) Vertebral height restoration was possible using kyphoplasty (average 66°) and for a subset of patients using vertebroplasty Cement leaks occurred for 41% and 9% of treated vertebrae for vertebroplasty and kyphoplasty respectively New fractures of adjacent vertebrae occurred for both procedures at rates that are greater than the general osteoporotic population but approximately equivalent to the general osteoporotic population that had a previous vertebral fracture Discussion The pain relief experienced by patients is promising for both kyphoplasty and vertebroplasty in the short term (

Vertebroplasty and kyphoplasty: a systematic review of 69 clinical studies

Object The current North American experience with minimally invasive vertebro- and kyphoplasty is largely limited to the treatment of benign osteoporotic compression fractures. The objective of this study was to assess the safety and efficacy of these procedures for painful vertebral body (VB) fractures in cancer patients. Methods The authors reviewed a consecutive group of cancer patients (21 with myeloma and 35 with other primary malignancies) undergoing vertebro- and kyphoplasty at their institution. Ninety-seven (65 vertebro- and 32 kyphoplasty) procedures were performed in 56 patients during 58 treatment sessions. The mean patient age was 62 years (+/- 13 years [standard deviation]) and the median duration of symptoms was 3.2 months. All patients suffered intractable spinal pain secondary to VB fractures. Patients noted marked or complete pain relief after 49 procedures (84%), and no change after five procedures (9%); early postoperative Visual Analog Scale (VAS) pain scores were unavailable in four patients (7%). No patient was worse after treatment. Reductions in VAS pain scores remained significant up to 1 year (p = 0.02, Wilcoxon signed-rank test). Analgesic consumption was reduced at 1 month (p = 0.03, Wilcoxon signed-rank test). Median follow-up length was 4.5 months (range 1 day-19.7 months). Asymptomatic cement leakage occurred during vertebroplasty at six (9.2%) of 65 levels; no cement extravasation was seen during kyphoplasty. There were no deaths or complications related to the procedures. The mean percentage of restored VB height by kyphoplasty was 42 +/- 21%. Conclusions Percutaneous vertebro- and kyphoplasty provided significant pain relief in a high percentage of patients, and this appeared durable over time. The absence of cement leakage-related complications may reflect the use of 1) high-viscosity cement; 2) kyphoplasty in selected cases; and 3) relatively small volume injection. Precise indications for these techniques are evolving; however, they are safe and feasible in well-selected patients with refractory spinal pain due to myeloma bone disease or metastases.

Percutaneous vertebroplasty and kyphoplasty for painful vertebral body fractures in cancer patients

Study Design. This was a retrospective review of 47 consecutive patients (1995–1998) in whom percutaneous intraosseous methylmethacrylate cement injection (percutaneous vertebroplasty) was used to treat osteoporotic vertebral compression fractures and spinal column neoplasms. Objectives. To present initial results regarding pain relief, spinal stabilization, and complications after treatment with percutaneous vertebroplasty. Summary of Background Data. Percutaneous vertebroplasty was developed in France in the late 1980s. Several European reports have described excellent results for treatment of compression fractures and neoplasms. The procedure was not performed in the United States until 1994. Only a single series of 29 patients treated in the United States has been reported. Methods. A retrospective review was conducted of 47 consecutive patients with 84 vertebrae treated with percutaneous vertebroplasty. Thirty-eight patients with 70 vertebrae had symptomatic, osteoporotic fractures and had failed medical therapy. Eight patients with 13 vertebrae had primary or metastatic neoplasms. One patient had a hemangioma. Immediate and long-term pain response, spinal stability, and complications were evaluated. Results. Among the 38 patients treated for osteoporotic fractures, 24 (63%) had marked to complete pain relief, 12 (32%) moderate relief and 2 (5%) no significant change. Only 4 of the 8 patients with malignancies had significant pain relief. In 7 of these patients, no further vertebral compression occurred, and spinal canal compromise was prevented. The patient with the hemangioma had no significant pain reduction. Minor complications occurred in 3 (6%) patients. Conclusions. Percutaneous vertebroplasty provided significant pain relief in a high percentage of patients with osteoporotic fractures. The procedure provided spinal stabilization in patients with malignancies but did not produce consistent pain relief. Complications were minor and infrequent. Percutaneous vertebroplasty is a promising therapy for patients with osteoporotic fractures and for selected vertebral column neoplasms.

Percutaneous vertebroplasty for pain relief and spinal stabilization

Acrylic cements have been used for the augmentation of weakened or partially destroyed bones for decades [(1)][1]. The term vertebroplasty originally described an open surgical procedure that introduces bone graft or acrylic cement to mechanically augment weakened vertebral bodies.

http://www.ajnr.org/content/ajnr/22/2/373.full.pdf

Michelle S. Barr

Papers

Percutaneous vertebroplasty for pain relief and spinal stabilization

Percutaneous vertebroplasty : a developing standard of care for vertebral compression fractures

751 Percutaneous Vertebroplasty for Pain Relief and Spinal Stabilization