Background Vertebroplasty is commonly used to treat painful, osteoporotic vertebral compression fractures. Methods In this multicenter trial, we randomly assigned 131 patients who had one to three painful osteoporotic vertebral compression fractures to undergo either vertebroplasty or a simulated procedure without cement (control group). The primary outcomes were scores on the modified Roland–Morris Disability Questionnaire (RDQ) (on a scale of 0 to 23, with higher scores indicating greater disability) and patients' ratings of average pain intensity during the preceding 24 hours at 1 month (on a scale of 0 to 10, with higher scores indicating more severe pain). Patients were allowed to cross over to the other study group after 1 month. Results All patients underwent the assigned intervention (68 vertebroplasties and 63 simulated procedures). The baseline characteristics were similar in the two groups. At 1 month, there was no significant difference between the vertebroplasty group and the control group in...

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A randomized trial of vertebroplasty for osteoporotic spinal fractures

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.

https://pure.rug.nl/ws/files/6752619/Klazen_2010_Lancet.pdf

Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial

Transpedicular vertebroplasty for the treatment of compression fractures of the thoracic and lumbar spine has been well described, and the reported complication rates are low. In this paper we present two cases of patients treated with vertebroplasty despite a history of prior infection. Osteomyelitis and abscess developed in these patients and they underwent corpectomy with anterior reconstruction and posterior stabilization. Great care should be taken when using vertebroplasty to treat patients who have a history of infection, because they may suffer osteomyelitis.

Report of two cases and review of the literature

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.

/pdf/vertebroplasty-and-kyphoplasty-a-systematic-review-of-69-27mm39raap.pdf

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

Study Design. Ex vivo biomechanical study using osreoporotic cadavetic vertebral bodies. Objective. To determine the association between the volume of compent injected during percutaneous vertebroplasty and the restoration of strength and stiffness in osteoporotic vertebral bodies, two investigational cements were studied: Orthocomp (Orthovita, Malvern, PA) and Simplex 20 (Simplex P with 20% by weight barium sulfate content: Stryker-Howmedica-Osteonics, Rutherford, NJ). Summary of Background Data. Previous biomechanical studies have shown that injections of 8-10 mL of cement during vertebroplasty restore or increase vertebral body strength and stiffness; however, the doseresponse association between cement volume and restoration of strength and stiffness is unknown. Methods. Compression fractures were experimentally created in 144 vertebral bodies (T6-L5) obtained from 12 osteoporotic spines harvested from female cadavers. After initial strength and stiffness were determined, the vertebral bodies were stabilized using bipedicular injections of cement totaling 2, 4, 6, or 8 mL and recompressed, after which post-treatment strength and stiffness were measured. Strength and stiffness were considered restored when post-treatment values were not significantly different from initial values. Results. Strength was restored for all regions when 2 mL of either cement was injected. To restore stiffness with Orthocomp, the thoracic and thoracolumbar regions required 4 mL, but the lumbar region required 6 mL. To restore stiffness with Simplex 20, the thoracic and lumbar regions required 4 mL, but the thoracolumbar region required 8 mL. Conclusion. These data provide guidance on the cement volumes needed to restore biomechanical integrity to compressed osteoporotic vertebral bodies.

The biomechanics of vertebroplasty. The effect of cement volume on mechanical behavior.

of compression fracture. Methods. Compression fractures were experimentally created in 16 osteoporotic VBs assigned to either the tamp or percutaneous vertebroplasty group. The tamp treatment consisted of inserting balloon-like devices into the vertebral body, inflating the bone tamp, and filling the void with Simplex P (Howmedica, Rutherford, NJ) bone cement. The percutaneous vertebroplasty treatment consisted of directly injecting Cranioplastic bone cement (CMW, Blackpool, UK) into the vertebral body. Pre- and posttreatment heights were measured, and the repaired vertebral bodies were recompressed to determine posttreatment strength and stiffness values. Results. The tamp treatment resulted in significant restoration (97%) of vertebral body height lost after compression, whereas percutaneous vertebroplasty treatment resulted in a significantly lower restoration of lost height (30%) (P , 0.05). Both treatments resulted in significantly stronger vertebral bodies relative to their initial state (P , 0.05). The tamp treatment restored vertebral body stiffness to initial values, but the percutaneous vertebroplasty treatment did not (P , 0.05). Conclusions. Tamp treatment resulted in significantly greater height restoration than did percutaneous vertebroplasty, without loss of vertebral body strength or stiff

An ex vivo biomechanical evaluation of an inflatable bone tamp used in the treatment of compression fracture.

A bone screw system (100) is provided that includes a cannulated bone screw (110) and an adapter (140) designed to be releasably coupled to the screw (110). The screw (110) has a head (112) with an opening (126) formed therein. A shank portion (114) of screw (110) extends from the head (112) and has a closed end bore (124) formed therein in open communication with the opening (126). The screw (110) has a threaded portion (116) in which a plurality of apertures (122) are formed in a root portion (120) of the thread. The adapter (140) has a distal end (150) adapted for releasable coupling with the head (112) and has a passage (162) extending longitudinally therethrough for open communication with the bore (124) of the screw (110). The adapter (140) further includes a grip portion (154) formed by a plurality of spaced annular ridges (156). The proximal end of adapter (140) has a fitting (142) formed thereon for coupling to a device for dispensing a purchase enhancing composition, through the adapter (140) and bore (124) to the apertures (122).

Bone screw system

Study Design. An ex vivo biomechanical study was conducted using osteoporotic cadaveric vertebral bodies. Objective. To determine the relationship between the percentage of osteoporotic vertebral body volume filled with polymethylmethacrylate cement during percutaneous vertebroplasty and the percentage restoration of strength and stiffness. of Background Data. A previous biomechanical study reported a weak relationship between the volume of cement injected and restoration of vertebral body strength and stiffness. Vertebral bodies vary considerably in size among regions and among spines, and the weak correlation may be attributed to the fact that the volume of vertebral bodies was not explicitly considered. Methods. The volume of 120 vertebral bodies (T6-L5) harvested from 10 osteoporotic female cadaver spines was determined by Archimedean displacement. Compression fractures were experimentally created, and initial strength and stiffness were determined. The vertebra bodies were stabilized using bipedicular injections of 2-8 mL of cement and then recompressed, after which post-treatment strength and stiffness were measured. Linear regression was used to analyze the relationship between percentage of volume fill and percentage of restored stiffness and strength. Results. The correlations between percentage of fill and restored strength and stiffness were weak: t 3 = 0.21 and r 2 = 0.27, respectively. On average, restoration of strength and stiffness required vertebral body cement fills of 16.2% and 29.8%, respectively. Conclusion. Strength and stiffness are weakly correlated with the percentage fill volume of cement injected during vertebroplasty.

The effect of vertebral body percentage fill on mechanical behavior during percutaneous vertebroplasty.

http://www.scvir.org/clinical/cpg/S311.pdf

John M. Mathis

Papers

The biomechanics of vertebroplasty. The effect of cement volume on mechanical behavior.

An ex vivo biomechanical evaluation of an inflatable bone tamp used in the treatment of compression fracture.

Bone screw system

The effect of vertebral body percentage fill on mechanical behavior during percutaneous vertebroplasty.

Society of Interventional Radiology quality improvement guidelines for percutaneous vertebroplasty.