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Eeric Truumees

Publications and source records attributed to Eeric Truumees.

11 recordsLinked to original sources
PubMed2005

A 2-year follow-up pilot study evaluating the safety and efficacy of op-1 putty (rhbmp-7) as an adjunct to iliac crest autograft in posterolateral lumbar fusions.

The ability of bone morphogenetic proteins (BMPs) to induce bone formation has led to a multitude of investigations into their use as bone graft substitutes in spinal surgery. The purpose of this multi-center clinical pilot study was to evaluate the safety and efficacy of BMP-7 (osteogenic protein 1, OP-1), in the form of a putty, combined with autograft for intertransverse process fusion of the lumbar spine in patients with symptomatic spinal stenosis and degenerative spondylolisthesis following spinal decompression. Twelve patients with spinal stenosis and degenerative lumbar spondylolisthesis underwent a laminectomy and partial or complete medial facetectomy as required for decompression of the neural elements, followed by an intertransverse process fusion by placing iliac crest autograft and OP-1 putty between the decorticated transverse processes. No instrumentation was used. Patients were followed clinically using the Oswestry scale and SF-36 outcome forms, and radiographically using static and dynamic radiographs to assess their fusion status over a 2-year period. Independent and blinded radiologists assessed the films for the presence of bridging bone between the transverse processes and measured translation and angulation on dynamic films using digital calipers. Radiographic outcome was compared to a historical control (autograft alone fusion without instrumentation for the treatment of degenerative spondylolisthesis). All adverse events were recorded prospectively. The results showed eight of the nine evaluable patients (89%) obtained at least a 20% improvement in their preoperative Oswestry score, while five of ten patients (50%) with radiographic follow-up achieved a solid fusion by the criteria used in this study. Bridging bone on the anteroposterior film was observed in seven of the ten patients (70%). No systemic toxicity, ectopic bone formation, recurrent stenosis or other adverse events related to the OP-1 putty implant were observed. A successful fusion was observed in slightly over half the patients in this study, using stringent criteria without adjunctive spinal instrumentation. This study did not demonstrate the statistical superiority of OP-1 combined with autograft over an autograft alone historical control, in which the fusion rate was 45%. There were no adverse events related to the OP-1 putty implant in this study, which supports findings in other studies suggesting the safety of bone morphogenetic proteins in spinal surgery.

Aged↗
PubMed2004

A pilot study evaluating the safety and efficacy of OP-1 Putty (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis for degenerative spondylolisthesis.

STUDY DESIGN: A prospective, randomized, controlled, multicenter clinical study was conducted. OBJECTIVE: To compare the clinical and radiographic outcomes of patients treated with OP-1 (BMP-7) Putty to autogenous iliac crest bone graft for one-level uninstrumented posterolateral fusion of the lumbar spine following decompressive laminectomy for the treatment of symptomatic degenerative spondylolisthesis with spinal stenosis. BACKGROUND: Preclinical studies have demonstrated that osteoinductive recombinant human osteogenic protein 1 in the form of OP-1 Putty is successful at achieving a posterolateral fusion in rabbits and dogs without any significant safety concerns. METHODS: Thirty-six patients with degenerative lumbar spondylolisthesis and symptoms of neurogenic claudication were randomized (2:1) to either OP-1 Putty (3.5 mg of OP-1 per side) or autogenous iliac crest bone graft for one-level uninstrumented posterolateral fusion following a decompressive laminectomy. Enrollment in the study was complete when 24 OP-1 Putty patients and 12 autograft patients had been randomized and treated. A patient administered Oswestry scale and SF-36 scale were used to determine clinical outcomes. Independent, blinded neuroradiologists reviewed both static and dynamic radiographs to determine fusion status. RESULTS: At the 1-year follow-up, 32 patients were available for clinical analysis and 29 patients were available for radiographic review. Clinical success as measured on the Oswestry scale was achieved by 18 of 21 (86%) OP-1 Putty patients and 8 of 11 (73%) autograft patients. SF-36 pain index scores showed similar results. Fourteen of 19 (74%) OP-1 Putty patients and 6 of 10 (60%) autograft patients achieved a successful posterolateral fusion fulfilling all fusion criteria. Of the 29 evaluable patients, 15 were both clinical and radiographic successes, 5 were radiographic successes but were clinical failures, 1 patient was both a radiographic and clinical failure, and 8 patients were radiographic failures but were clinical successes. No systemic toxicity, ectopic bone formation, recurrent stenosis, or other adverse events related to the OP-1 Putty implant were observed. CONCLUSION: Although the posterolateral spine is a challenging fusion environment in patients with degenerative spondylolisthesis, successful radiographic fusion was obtained using OP-1 Putty at a rate that was similar to autograft given the number of patients in this study. Importantly, there were no apparent adverse consequences related to the use of the OP-1 Putty implant in this patient population.

Adult↗
PubMed2004

Imaging of the postoperative spine.

With the widespread prevalence of back pain, and approximately 200,000 lumbar spine operations annually in the United States, imaging of the postoperative lumbar spine has become a major diagnostic issue. The many causes of the failed back surgery syndrome make the diagnosis of the etiology of the patient's symptom complex very important to the treating physician. With the varied types of surgery, the increasing use of fusion hardware, and the myriad of complicating factors, the imaging strategy must be flexible enough to be comprehensive in the evaluation of these difficult patients. This article will address the normal and abnormal findings after lumbar spine surgery.

Diagnostic Imaging↗
PubMed2003

Failure of human cervical endplates: a cadaveric experimental model.

STUDY DESIGN: An in vitro biomechanical study using a servohydraulic testing machine on cadaveric endplates. OBJECTIVES: To characterize the effects of bone mineral density, endplate geometry, and preparation technique on endplate failure load. SUMMARY OF BACKGROUND DATA: The effects of endplate preparation methods on failure loads are only partly characterized in the literature. Endplate burring has been recommended to increase fusion rates. However, graft subsidence may complicate anterior reconstruction procedures. METHODS: After radiographic screening, 21 cadaveric cervical spines underwent dual-energy x-ray absorptiometry scanning to quantify mineral content. Endplate geometry was calculated in 55 randomly selected endplates from the inferior C2 to the superior T1 levels. These vertebrae were embedded in polyester resin and randomly left intact, perforated, or burred. The cervical endplates were loaded at a rate of 0.2 mm/s on an Instron materials tester with an attached 9 mm diameter polycarbonate rod (an area of 64 mm2). A stepwise, univariate linear regression was used to compare the point of endplate failure with the vertebral level, endplate area, gender, age, bone mineral density, and preparation technique. RESULTS: Mean bone mineral density, as measured by dual-energy x-ray absorptiometry, was 0.713 g/cm2 (+/- 0.173 g/cm2). Mean endplate area was calculated at 323 mm2. A mean compressive force of 754 N (+/- 445 N) was required before endplate failure. Trends toward increasing compressive loads were noted with decreasing endplate area and increasing bone mineral density. Increasing age (P = 0.0203), caudal vertebral level (P < 0.0001), endplate burring (P = 0.0068), and female gender (P = 0.0452) were associated with significantly lower endplate fracture loads in compression. CONCLUSIONS: Bone quality was predictive of endplate compressive failure loads. Intact endplates failed at significantly higher loads than their perforated or burred counterparts.

Aged↗
PubMed2003

A pilot safety and efficacy study of OP-1 putty (rhBMP-7) as an adjunct to iliac crest autograft in posterolateral lumbar fusions.

The ability of bone morphogenetic proteins (BMPs) to induce bone formation has led to an increasing interest in the potential for their use in fusion surgery. The purpose of this multi-center clinical pilot study was to evaluate the safety of one such BMP-osteogenic protein 1, in the form of OP-1 putty-combined with autograft for intertransverse process fusion of the lumbar spine in patients with symptomatic spinal stenosis and degenerative spondylolisthesis following spinal decompression. Twelve patients with spinal stenosis and degenerative lumbar spondylolisthesis underwent laminectomy and partial or complete medial facetectomy as required for decompression of the neural elements followed by intertransverse process fusion by placing iliac crest autograft and OP-1 putty between the decorticated transverse processes. No instrumentation was used. Patients were followed clinically using the Oswestry scale and radiographically using static and dynamic radiographs to assess their fusion status. Independent and blinded radiologists assessed the films for the presence of bridging bone between the transverse processes and measured translation and angulation on dynamic films using digital calipers. In addition to bridging bone, less than or equal to 5 degrees of angular motion and less than or equal to 2 mm of translation were required to classify the patients as successfully fused, as per the definition of successful fusion provided by the FDA for use in clinical trials involving investigational devices to attain spinal fusion. Radiographic outcome was compared to a historical control (autograft alone fusion without instrumentation for the treatment of degenerative spondylolisthesis). All adverse events were recorded prospectively. The results showed 9 of the 12 patients (75%) obtained at least a 20% improvement in their preoperative Oswestry score, while 6 of 11 patients (55%) with radiographic follow-up achieved a solid fusion by the criteria used in this study. Bridging bone on the anteroposterior film was observed in 10 of the 11 patients (91%). No systemic toxicity, ectopic bone formation, recurrent stenosis or other adverse events related to the OP-1 putty implant were observed. A successful fusion was observed in slightly over half the patients in this study, using stringent criteria without adjunctive spinal instrumentation. This study did not demonstrate the superiority of OP-1 combined with autograft over an autograft alone historical control, in which the fusion rate was approximately 45%. The lack of adverse events related to the OP-1 putty implant in this study is in agreement with other studies supporting the safety of bone morphogenetic proteins in spinal surgery.

Aged↗
PubMed2003

Effects of a cervical compression plate on graft forces in an anterior cervical discectomy model.

STUDY DESIGN: An ex vivo biomechanical study using an instrumented distractor and load cells in a cadaveric multilevel discectomy construct was conducted. OBJECTIVE: To demonstrate that a dynamic cervical plate can be used to increase compressive load on interbody grafts in a multilevel discectomy specimen. SUMMARY OF BACKGROUND DATA: Cervical plating is used to decrease pseudarthrosis, graft extrusion, and graft subsidence in multilevel anterior discectomy procedures. Plating may shield a graft as it resorbs and may reverse normal loading mechanics. METHODS: Preoperative disc height was measured in five cadaveric spines. A three-level discectomy was performed. The disc spaces were opened with a distractor instrumented with strain gauges to allow the introduction of spacers fixed rigidly to subminiature load cells. Distraction was removed, and immediate compressive forces were measured by the load cells. An external compressor was applied followed by a cervical plate. The specimen then was placed in a loading frame, and final compressive forces were measured. RESULTS: A mean 116.5 N distractive force was required to insert grafts into all three levels. No significant relation between preoperative disc height and distractive or compressive forces was noted. Release of the distractor yielded an immediate compressive load on each graft. The compressor significantly increased graft compression. After plate application, the external compressor was removed. Graft compression did not significantly decrease. In the loading frame, an increase in compressive load was noted. CONCLUSIONS: Preoperative disc height was not related to the compressive force on the graft. Compressive force can be increased and maintained with a dynamic plating system.

Aged↗
PubMed2003

Medical consequences of osteoporotic vertebral compression fractures.

Osteoporotic vertebral compression fractures are an increasingly common source of morbidity and mortality in the aging population. Previously, these fractures were assumed to be benign, self-limited entities with few, if any, significant sequelae. More recently, however, individual cohorts and population-wide analyses demonstrate high rates of chronic pain, functional decline, physiologic disorder, psychosocial dysfunction, and early mortality among patients with osteoporotic vertebral body compression fractures.

Aged↗
PubMed2002

Effects of disc height and distractive forces on graft compression in an anterior cervical discectomy model.

STUDY DESIGN: An in vitro biomechanical study using a calibrated distractor and a subminiature load cell in a cadaver anterior cervical discectomy construct was conducted. OBJECTIVE: To study the interrelations of preoperative disc height, graft height, and compressive and distractive forces in an anterior cervical discectomy model. SUMMARY OF BACKGROUND DATA: The effects of graft size on compressive and distractive forces in a discectomy model remain unknown. Larger grafts afford neural decompression through anterior column distraction. This distraction may subject the graft and vertebral bodies to excessive loads, increasing graft fracture, and subsidence risk. METHODS: Disc height was measured radiographically in 18 specimens. A Smith-Robinson discectomy was performed, and the superior and inferior ends of the specimens were embedded in polyester resin. Distraction was applied through a calibrated Caspar distractor to measure the distractive force applied while steel spacers rigidly fixed to a subminiature load cell were introduced. After distraction was removed, immediate compressive force was measured. RESULTS: Distractive forces of 112.4 N and 189.9 N were required to insert the 6-mm and 8-mm grafts, respectively. When this distractive force was removed, immediate compressive loads of 8.8 N and 21.5 N on the graft were noted. When a compressive load of 45 N was applied in a loading frame, measured graft loads of 16.2 N and 29.2 N also increased. No statistically significant relation was observed between preoperative disc height and distractive force or compression of the graft. Significantly lower distractive and compressive forces were associated with insertion of the 6-mm rather than 8-mm graft. CONCLUSIONS: Significantly higher distractive and compressive forces were recorded with larger grafts. Preoperative disc height was not an accurate predictor of graft loads.

Aged↗
PubMedDate not supplied

Percutaneous vertebral augmentation.

BACKGROUND CONTEXT: With the aging of the population, painful osteoporotic compression fractures are becoming more common. PURPOSE: To review the physiologic implications of these injuries as well as treatment options and outcomes, especially with reference to newer, percutaneous "augmentation" procedures, that is, vertebroplasty and kyphoplasty. STUDY DESIGN/SETTING: A literature review. METHODS: No direct, randomized studies comparing vertebroplasty, kyphoplasty and standard, nonoperative care are available. RESULTS: The growing literature suggests a role for kyphoplasty and vertebroplasty in the management of patients with intractable pain or progressive vertebral collapse after vertebral compression fracture. Both procedures likely offer similar rates of pain relief. Kyphoplasty, although more expensive, may allow fracture reduction. The void created with the balloon tamp allows a more viscous cement to be applied, thereby decreasing the risk of extravasation. CONCLUSIONS: More study is required to understand the ideal role of these new techniques in the management of spinal osteoporosis and associated fractures. However, for carefully selected cases, current data suggest that the complication rates are low and pain relief can be profound.

Aged↗
PubMedDate not supplied

Bone grafting alternatives in spinal surgery.

BACKGROUND CONTEXT: Bone grafting is used to augment bone healing and provide stability after spinal surgery. Autologous bone graft is limited in quantity and unfortunately associated with increased surgical time and donor-site morbidity. Alternatives to bone grafting in spinal surgery include the use of allografts, osteoinductive growth factors such as bone morphogenetic proteins and various synthetic osteoconductive carriers. PURPOSE: Recent research has provided insight into methods that may modulate the bone healing process at the cellular level in addition to reversing the effects of symptomatic disc degeneration, which is a potentially disabling condition, managed frequently with various fusion procedures. With many adjuncts and alternatives available for use in spinal surgery, a concise review of the current bone grafting alternatives in spinal surgery is necessary. STUDY DESIGN/SETTING: A systematic review of the contemporary English literature on bone grafting in spinal surgery, including abstract information presented at national meetings. METHODS: Bone grafting alternatives were reviewed as to their efficacy in extending or replacing autologous bone graft sources in spinal applications. RESULTS: Alternatives to autologous bone graft include allograft bone, demineralized bone matrix, recombinant growth factors and synthetic implants. Each of these alternatives could possibly be combined with autologous bone marrow or various growth factors. Although none of the presently available substitutes provides all three of the fundamental properties of autograft bone (osteogenicity, osteoconductivity and osteoinductivity), there are a number of situations in which they have proven clinically useful. CONCLUSIONS: Alternatives to autogenous bone grafting find their greatest appeal when autograft bone is limited in supply or when acceptable rates of fusion may be achieved with these substitutes (or extenders) despite the absence of one or more of the properties of autologous bone graft. In these clinical situations, the morbidity of autograft harvest is reasonably avoided. Future research may discover that combinations of materials may cumulatively result in the expression of osteogenesis, osteoinductivity and osteoconductivity found in autogenous sources.

Animals↗