Open and closing wedge high tibial osteotomies are a successful choice of treatment for unicompartmental degenerative diseases with associated varus in active patients. Survival of both techniques is comparable in our series and is associated with low pain scores, high satisfaction and high activity levels of the survivors.
Prospective consecutive series cases study to investigate the clinical and radiological results of standalone balloon kyphoplasty and cement augmentation with calcium phosphate in traumatic fractures. Independent observer evaluation of radiological and computer tomography results, visual analogue scale (VAS), Roland-Morris score and complications with acute traumatic compression fractures type A, treated with a standalone balloon kyphoplasty and cement augmentation with calcium phosphate (Calcibon TM ); follow-up time at a mean of 30 months (24-37 months). From August 2002 to August 2003, consecutive patients with traumatic compression fractures (Magerl type A) without neurological deficit underwent standalone kyphoplasty with Calcibon. We report here the pre-, post-operative and the followup results, applying the VAS (0-10) for pain rating, the Roland-Morris (0-24) disability score, CT-scan examination, detailed radiographic evaluation of vertebral body (VB) deformity and segmental kyphosis measurement. The pre-operative X-ray measurements, VAS and the 7 days Roland-Morris scores are compared with the post-operative and the 30 months follow-up findings. Twenty-eight patients with 33 treated fracture levels were included in this study. The mean initial vertebral deformity (VB kyphosis) was 17°, corrected to a post-operative of 6°. We noted a loss of correction at the follow-up in comparison to the post-operative standing X-ray at 24 h of 3°ver-tebral deformity and 3°segmental kyphosis. The VAS score demonstrates a decrease over time from a mean of 8.7-3.1 at 7 days and to 0.8 at the last follow-up. The Roland-Morris disability score demonstrates a similar improvement. We noticed no major complications related to the procedure. The mean cement resorption after 1 year was 20.3% (0.3-35.3%) and is related to the individual biological resorption process and is not predictable. All patients with vertebral fractures as sole medical problem were discharged within 48 h. All active patients returned to the same work within 3 months with the same working ability as before the accident. Standalone balloon kyphoplasty is a potential alternative mini-invasive technique to reduce the fractures. However, due to the intrinsic characteristic of calcium phosphate cement (Calcibon) we recommend the application of this biological cement for standalone reduction and stabilisation only in fractures type A1 and A3.1 in young patient. In case of higher destruction levels of the VB, we propose the utilisation of Calcibon associated with posterior instrumentation. Having regard to the pointed out indications, our preliminary results demonstrate a new possibility to treat this kind of fractures, allowing a rapid handling of pain, early discharge and return to normal activities.
BACKGROUND CONTEXT: Balloon kyphoplasty (BKP) is a commonly performed vertebral augmentation procedure for painful osteoporotic vertebral compression fractures (OVCFs). OBJECTIVE: This study aimed to support a non-inferiority finding for the use of a titanium implantable vertebral augmentation device (TIVAD) compared to BKP. STUDY DESIGN: Prospective, parallel group, controlled comparative randomized study.FDA device/drug status: The devices are FDA approved or approved by corresponding national agencies for this indication. The SpineJack Ò is commercially available in Europe. KyphX Xpander Ò Inflatable Bone Tamp is commercially available in the United States and Europe.
This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (−5.4 ± 6.3°; p < 0.001), remained at 12 months (−4.4 ± 6.0°, p = 0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.
BackgroundUp to one third of BKP treated cases shows no appreciable height restoration due to loss of both restored height and kyphotic realignment after balloon deflation. This shortcoming has called for an improved method that maintains the height and realignment reached by the fully inflated balloon until stabilization of the vertebral body by PMMA-based cementation. Restoration of the physiological vertebral body height for pain relief and for preventing further fractures of adjacent and distant vertebral bodies must be the main aim for such a method. A new vertebral body stenting system (VBS) stabilizes the vertebral body after balloon deflation until cementation. The radiographic and safety results of the first 100 cases where VBS was applied are presented.MethodsDuring the planning phase of an ongoing international multicenter RCT, radiographic, procedural and followup details were retrospectively transcribed from charts and xrays for developing and testing the case report forms. Radiographs were centrally assessed at the institution of the first/senior author.Results100 patients (62 with osteoporosis) with a total of 103 fractured vertebral bodies were treated with the VBS system. 49 were females with a mean age of 73.2 years; males were 66.7 years old. The mean preoperative anterior-middle-posterior heights were 20.3-17.6-28.0 mm, respectively. The mean local kyphotic angle was 13.1°. The mean preoperative Beck Index (anterior edge height/posterior edge height) was 0.73, the mean alternative Beck Index (middle height/posterior edge height) was 0.63. The mean postoperative heights were restored to 24.5-24.6-30.4 mm, respectively. The mean local kyphotic angle was reduced to 8.9°. The mean postoperative Beck Index was 0.81, the mean alternative one was 0.82. The overall extrusion rate was 29.1%, the symptomatic one was 1%. In the osteoporosis subgroup there were 23.8% extrusions. Within the three months followup interval there were 9% of adjacent and 4% of remote new fractures, all in the osteoporotic group.ConclusionsVBS showed its strengths especially in realignment of crush and biconcave fractures. Given that fracture mobility is present, the realignment potential is sound and increases with the severity of preoperative vertebral body deformation.
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