The combination of recombinant human bone morphogenetic protein-2 (rhBMP-2) on an absorbable collagen sponge (ACS) carrier has been shown to induce bone formation in a number of preclinical and clinical investigations. In 2002, rhBMP-2/ACS at a 1.5-mg/cc concentration (INFUSE® Bone Graft, Medtronic Spinal and Biologics, Memphis, TN) was FDA-approved as an autograft replacement for certain interbody spinal fusion procedures. In 2004, INFUSE® Bone Graft was approved for open tibial fractures with an intermedullary (IM) nail fixation. Most recently, in March 2007, INFUSE® Bone Graft was approved as an alternative to autogenous bone grafts for sinus augmentations, and for localised alveolar ridge augmentations for defects associated with extraction sockets. The culmination of extensive preclinical and clinical research and three FDA approvals makes rhBMP-2 one of the most studied, published and significant advances in orthopaedics. This review article summarises a number of clinical findings of rhBMP-2/ACS, including the FDA-approved investigational device exemption (IDE) studies used in gaining the aforementioned approvals.

/pdf/a-comprehensive-clinical-review-of-recombinant-human-bone-1k0qta1raj.pdf

A comprehensive clinical review of recombinant human bone morphogenetic protein-2 (INFUSE Bone Graft).

An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy.

Complications with the use of bone morphogenetic protein 2 (BMP-2) in spine surgery

Study Design. Retrospective, multicenter study of robotically-guided spinal implant insertions. Clinical acceptance of the implants was assessed by intraoperative radiograph, and when available, postoperative computed tomography (CT) scans were used to determine placement accuracy. Objective. To verify the clinical acceptance and accuracy of robotically-guided spinal implants and compare to those of unguided free-hand procedures. Summary of Background Data. SpineAssist surgical robot has been used to guide implants and guide-wires to predefined locations in the spine. SpineAssist which, to the best of the authors' knowledge, is currently the sole robot providing surgical assistance in positioning tools in the spine, guided over 840 cases in 14 hospitals, between June 2005 and June 2009. Methods. Clinical acceptance of 3271 pedicle screws and guide-wires inserted in 635 reported cases was assessed by intraoperative fluoroscopy, where placement accuracy of 646 pedicle screws inserted in 139 patients was measured using postoperative CT scans. Results. Screw placements were found to be clinically acceptable in 98% of the cases when intraoperatively assessed by fluoroscopic images. Measurements derived from postoperative CT scans demonstrated that 98.3% of the screws fell within the safe zone, where 89.3% were completely within the pedicle and 9% breached the pedicle by up to 2 mm. The remaining 1.4% of the screws breached between 2 and 4 mm, while only 2 screws (0.3%) deviated by more than 4 mm from the pedicle wall. Neurologic deficits were observed in 4 cases yet, following revisions, no permanent nerve damage was encountered, in contrast to the 0.6% to 5% of neurologic damage reported in the literature. Conclusion. SpineAssist offers enhanced performance in spinal surgery when compared to free-hand surgeries, by increasing placement accuracy and reducing neurologic risks. In addition, 49% of the cases reported herein used a percutaneous approach, highlighting the contribution of SpineAssist in procedures without anatomic landmarks.

Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study.

Psychosocial factors are important determinants of pain intensity and disability in patients with disabling musculoskeletal pain. The psychosocial aspects of disabling musculoskeletal pain include cognitive (e.g., beliefs, expectations, and coping style), affective (e.g., depression, pain anxiety, heightened concern about illness, and anger), behavioral (e.g., avoidance), social (e.g., secondary gain), and cultural factors. The effectiveness of cognitive behavioral therapy and other treatments that address the psychosocial aspects of disabling musculoskeletal pain has been confirmed in numerous high-quality studies.

Psychosocial aspects of disabling musculoskeletal pain.

Forty-nine patients underwent minimally invasive transforaminal lumbar interbody fusion (TLIF) from October 2001 to August 2002 (minimum 18-month follow-up). The diagnosis was degenerative disc disease with herniated nucleus pulposus (HNP) in 26, spondylolisthesis in 22, and a Chance-type seatbelt fracture in 1. The majority of cases (n = 45) were at L4-L5 or L5-S1. A paramedian, muscle-sparing approach was performed through a tubular retractor docked unilaterally on the facet joint. A total facetectomy was then conducted, exposing the disc space. Discectomy and endplate preparation were completed through the tube using customized surgical instruments. Structural support was achieved with allograft bone or interbody cages. Bone grafting was done with local autologous or allograft bone, augmented with recombinant human bone morphogenetic protein-2 in some cases. Bilateral percutaneous pedicle screw-rod placement was accomplished with the Sextant system. There were no conversions to open surgery. Operative time averaged 240 minutes. Estimated blood loss averaged 140 mL. Mean length of hospital stay was 1.9 days. All patients presenting with preoperative radiculopathy (n = 45) had resolution of symptoms postoperatively. Complications included two instances of screw malposition requiring screw repositioning and two cases of new radiculopathy postoperatively (one from graft dislodgement, the other from contralateral neuroforaminal stenosis). Narcotic use was discontinued 2-4 weeks postoperatively. Improvements in average Visual Analogue Pain Scale and Oswestry Disability Index (preoperative to last follow-up) scores were 7.2-2.1 and 46-14, respectively. At last follow-up, all patients had solid fusions by radiographic criteria. Results of this study indicate that minimally invasive TLIF is feasible and offers several potential advantages over traditional open techniques.

Minimally invasive transforaminal lumbar interbody fusion (TLIF): technical feasibility and initial results.

The authors provide an overview of the minimally invasive transforaminal lumbar interbody fusion (TLIF) procedure including indications, technique, and complications. This novel technique is a method of achieving circumferential lumbar fusion using a unilateral dorsal approach. Minimally invasive TLIF uses a tubular retractor that is inserted via a muscle-dilating exposure, thereby minimizing the approach-related morbidity. This procedure is ideal for refractory mechanical low-back and radicular pain associated with spondylolisthesis, degenerative disc disease, and recurrent disc herniation. The authors' clinical experience and review of the medical literature indicate that TLIF can be effectively and safely performed in a minimally invasive fashion.

/pdf/minimally-invasive-transforaminal-lumbar-interbody-fusion-12k17zu2yy.pdf

Minimally invasive transforaminal lumbar interbody fusion: indications, technique, and complications.

Background Context Both open and minimally invasive lumbar fusion surgeries (MIS) are used to treat patients with symptomatic degenerative spinal pathologies. Open lumbar fusion surgery studies have reported excellent short-term safety and long-term clinical outcomes. MIS has shown excellent safety and short-term clinical success, but there is very little information on its long-term clinical durability. Purpose The purpose of this study was to document the long-term clinical durability and safety of patients treated with minimally invasive surgery—transforaminal lumbar interbody fusion (MIS TLIF). Secondary purposes were to evaluate the clinical outcomes of patients receiving fusion in 2 sequential lumbar disc segments (2-level) as compared with a single-level lumbar disc segment (1-level), and as an aside, to determine whether or not there were any differences in clinical outcomes in patients treated over the age of 60 years as compared with those under 60 years. Study Design This study was a retrospective review of prospective collected outcomes data. Patient Sample One hundred sixty-nine consecutive patients, with either isolated single-level or 2-level lumbar intervertebral segment pain manifested by back pain alone or back pain with leg pain associated with a primary diagnosis of degenerative spondylolisthesis, central herniated disc, central stenosis, Foraminal-lateral herniation of disc, Foraminal/lateral stenosis, or isolated degenerative disc or joint disease. Outcomes Measures Hospital stay time postoperative, return to work time, Oswestry Disability Index (ODI), visual analog pain scores (VAS), pain medicine (narcotic) use, fusion status, and reoperation rate. Methods Patients treated with 1or 2-level MIS TLIF were evaluated based on clinical outcomes, reoperation rates, and fusion status out to an average of 49 months postoperative (range, 36 to 60 mo). Effect of the number of levels fused, patient age, and worker compensation status on outcome was also assessed. Results Average surgery time was 183 minutes, with no difference between older and younger patients. Hospital stay averaged 15 hours with a median return to work time of 8 weeks. Return to work for patients working before surgery was 97%. ODI improved 36% at the first follow-up and was improved 41% at 49 months postoperative (P Conclusions The results of this study support the long-term clinical effectiveness of MIS TLIF for varying diagnoses. These results suggest that those undergoing a 1-level or 2-level lumbar fusion improve equally, and that older patients do well with MIS surgery long term. Reoperation rates were acceptable, with excellent surgical durability at 49 months. The benefit of decompression was not assessed in this study, and future studies should assess its impact long term.

Long-term durability of minimal invasive posterior transforaminal lumbar interbody fusion: a clinical and radiographic follow-up.

Clinical Outcomes of Minimally Invasive versus Open Single Level TLIF: A Propensity Matched Cohort Study

40. Radiation Exposure to Operating Room Personnel During Minimally Invasive Spine Surgery: A Comparison of Single vs. Simultaneous Dual Fluoroscopy

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