transforming-growth-factor-beta and Back-Pain

Randomized efficacy trial comparing two types of noninstrumented posterolateral fusion between L5 and S1 in patients with L5 spondylolysis and vertebral slip less than 50%, as evaluated by radiostereometric analysis.. To determine whether osteogenic protein-1 (BMP-7) in the OP-1 Implant yields better stabilizing bony fusion than autograft bone.. Animal studies of osteoinductive proteins in noninstrumented posterolateral fusions have shown high fusion rates. No similar conclusive study on humans has been performed.. For this study, 20 patients were randomized to fusion with either OP-1 Implant or autograft bone from the iliac crest, 10 in each group. The patients were instructed to keep the trunk straight for 5 months after surgery with the aid of a soft lumbar brace. At surgery 0.8-mm metallic markers were positioned in L5 and the sacrum, enabling radiostereometric follow-up analysis during 1 year. The three-dimensional vertebral movements, as measured by radiostereometric analysis induced by positional change from supine posture to standing and sitting, were calculated with an accuracy of 0.5 to 0.7 mm and 0.5 degrees to 2.0 degrees. Conventional radiography was added.. No significant difference was noted between the radiostereometric and radiographic results of fusion with the OP-1 Implant and fusion with autograft bone. There was a significant relation between reduced vertebral movements and better bone formation. No adverse effects of the OP-1 Implant occurred. Persistent minor pain at the iliac crest was noticed in one patient.. There was no significant difference between the two fusion versions. Thus, the OP-1 Implant did not yield better stabilizing bony fusion than autograft bone.

Topics: Adult; Awards and Prizes; Back Pain; Bone Morphogenetic Protein 7; Bone Morphogenetic Proteins; Bone Transplantation; Drug Implants; Female; Follow-Up Studies; Humans; Ilium; Imaging, Three-Dimensional; Lumbar Vertebrae; Male; Middle Aged; Osteogenesis; Prostheses and Implants; Radiography; Reoperation; Sacrococcygeal Region; Spinal Fusion; Spondylolysis; Transforming Growth Factor beta; Transplantation, Autologous; Treatment Outcome

The mRNA expressions of cytokines and chemokines were assessed in herniated lumbar disc specimens.. To investigate whether the mRNAs of interleukin (IL)-1alpha, tumor necrosis factor (TNF)-alpha, RANTES, IL-8, IL-10, and transforming growth factor (TGF)-beta are expressed in surgically obtained herniated disc specimens; and to discover which of them are the predominant cytokines associated with the clinical symptoms and signs, and whether any differences in the mRNA expression exist depending on the different types of disc herniations.. It has been postulated that cytokines are involved in causing radicular leg pain in lumbar disc herniations. Although a few studies have been done on lumbar disc herniations concerning IL-1alpha and TNF-alpha, almost none has been carried out in the cases of the other of cytokines and chemokines.. Using a reverse transcription-polymerase chain reaction, mRNA expressions of cytokines and chemokines were investigated in herniated disc specimens. The straight leg raising test, development of radicular pain by back extension, symptom duration, pain intensity using a visual analogue scale, and herniation types were described.. The mRNAs of IL-8, TNF-alpha, IL-1alpha, RANTES, and IL-10 were expressed in 16 (70%), 15 (65%), 9 (39%), 4 (17%), and 2 (9%) of the 23 herniated disc specimens, respectively. The mRNA of TGF-beta was expressed in 5 of 10 specimens (50%). IL-8 mRNA expression was associated with the development of radicular pain by back extension and short symptom duration (average 3.8 weeks). The mRNAs of IL-1alpha were expressed more frequently in transligamentous extensions than in subligamentous extensions, but the expression was weak.. Interleukin-8 appears to be associated with development of radicular pain by back extension and to be activated on acute or subacute disc herniations. IL-8 seems to participate in the pathomechanism of nerve root inflammation in lumbar disc herniations, which implies that it may be considered a target for therapeutic intervention.

Topics: Adult; Aged; Back Pain; Chemokine CCL5; Chemokines; Cytokines; Female; Humans; Interleukin-1; Interleukin-10; Interleukin-8; Intervertebral Disc Displacement; Lumbosacral Region; Male; Middle Aged; Predictive Value of Tests; Reverse Transcriptase Polymerase Chain Reaction; RNA, Messenger; Transforming Growth Factor beta; Tumor Necrosis Factor-alpha

The objectives of this study were to build upon previously-reported 12-month findings by retrospectively comparing 24-month follow-up hospitalization charges and potentially-relevant readmissions in US lumbar fusion surgeries that employed either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a nationwide healthcare system database.. A total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2 in the original study, of whom 3,792 patients (23.4%) were identified in the current study with all-cause readmissions during the 24-month follow-up period. Confounding baseline patient, procedure, and hospital characteristics found in the original study were used to adjust multivariate regression models comparing differences in 24-month follow-up hospitalization charges (in 2020 US dollars) and lengths of stay (LOS; in days) between the groups. Differences in potentially-relevant follow-up readmissions were also compared, and all analyses were repeated in the subset of patients who only received treatment at a single level of the spine.. The adjusted cumulative mean 24-month follow-up hospitalization charges in the full cohort were significantly lower in the V-CBA group ($99,087) versus the rhBMP-2 group ($124,389; P < 0.0001), and this pattern remained in the single-level cohort (V-CBA = $104,906 vs rhBMP-2 = $125,311; P = 0.0006). There were no differences between groups in adjusted cumulative mean LOS in either cohort. Differences in the rates of follow-up readmissions aligned with baseline comorbidities originally reported for the initial procedure. Subsequent lumbar fusion rates were significantly lower for V-CBA patients in the full cohort (10.12% vs 12.00%; P = 0.0002) and similar between groups in the single-level cohort, in spite of V-CBA patients having significantly higher rates of baseline comorbidities that could negatively impact clinical outcomes, including bony fusion.. The results of this study suggest that use of V-CBA for lumbar fusion surgeries performed in the US is associated with substantially lower 24-month follow-up hospitalization charges versus rhBMP-2, with both exhibiting similar rates of subsequent lumbar fusion procedures and potentially-relevant readmissions.

Topics: Aged; Allografts; Back Pain; Bone Morphogenetic Protein 2; Bone Transplantation; Female; Follow-Up Studies; Hospitalization; Humans; Lumbar Vertebrae; Male; Middle Aged; Patient Readmission; Recombinant Proteins; Retrospective Studies; Spinal Fusion; Transforming Growth Factor beta; Treatment Outcome; United States

Twenty-four-month outcomes have been reported for patients with degenerative lumbar disc disease who were treated with stand-alone anterior lumbar interbody arthrodesis with use of dual tapered interbody fusion cages and recombinant human bone morphogenetic protein-2. This report represents an update of the clinical and radiographic results of this treatment at six years.. Two hundred and seventy-seven patients with single-level degenerative disc disease with up to grade-I spondylolisthesis were enrolled in two prospective, multicenter, U.S. Food and Drug Administration-approved investigational device exemption studies and were treated with an open or a laparoscopic surgical procedure. The patients received recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge with lumbar fusion cage implants. One hundred and forty-six patients completed the six-year clinical follow-up evaluations, and 130 patients had complete radiographic follow-up at six years. Outcomes were determined with use of well-established clinical outcome measurements (Oswestry Disability Index, Short Form-36, and back and leg pain scores) and radiographic assessments.. At six years, 128 (98%) of the 130 patients treated with recombinant human bone morphogenetic protein-2 and stand-alone fusion cages had a fusion. The second surgery rate was 6.7% (eighteen patients) prior to two years and 3.7% (seven patients) from two to six years. A worst-case scenario analysis, which includes all second surgical procedures due to pseudarthrosis, resulted in a fusion rate at seventy-two months of 91% (128 of 141). Significant improvements in the Oswestry Disability Index scores, Short Form-36 health survey physical component summary scores, and back and leg pain scores were achieved by six weeks in both the open and laparoscopic groups and were sustained at six years (p < 0.001). The percentage of patients who were working at six months (63%) was higher than the percentage who had been working preoperatively (52%), and this improvement was sustained at six years (68%).. The use of dual tapered threaded fusion cages and recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge obtained and maintained intervertebral spinal fusion, improved clinical outcomes, and reduced pain after anterior lumbar interbody arthrodesis in patients with degenerative lumbar disc disease.

Topics: Adult; Arthrodesis; Back Pain; Bone Morphogenetic Protein 2; Bone Morphogenetic Proteins; Female; Gelatin Sponge, Absorbable; Humans; Leg; Lumbar Vertebrae; Male; Outcome Assessment, Health Care; Pain; Prospective Studies; Radiography; Recombinant Proteins; Reoperation; Spondylolisthesis; Transforming Growth Factor beta; Treatment Outcome

Observational study with prospective CT analysis.. To assess the incidence and clinical sequelae of epidural bone formation following the adjunctive use of recombinant bone morphogenetic protein 2 (rhBMP2) with local autogenous bone graft use of (rhBMP2) in minimal access interbody (PLIF and TLIF) fusions.. The use of rhBMP2 for interbody fusion is associated with high fusion rates. However, for posterior approaches, concerns regarding heterotopic bone formation within the epidural space have been raised.. An independent CT analysis of 33 consecutive patients following minimal access lumbar fusion (PLIF [n = 10] or TLIF [n = 23]) with [n = 23] and without [n = 10] rhBMP2 was performed. Bone formation was graded in a centrifugal manner (intradiscal, anular/ALL/PLL, epidural [canal/foramen] and beyond the spine). In all BMP cases, a constant dose of 4.2 mg/disc level was administered (lowest commercially available dose). In all cases, local autograft was used. Review and assessment of prospectively collected outcomes data were performed.. Average clinical and CT (minimum 6 months) follow-up was 25.0 and 7.9 months, respectively. Bridging bone (fusion) was seen in 100% of the BMP group and 90% without BMP. Epidural bone formation occurred in 20.8% with the use of BMP (5 levels: n = 1 spinal canal and n = 4 within the foramen) compared with 8.3% (1 level: canal) without BMP. Foraminal bone formation was seen only in the TLIF group. All epidural bone formation was heterotopic, and no ectopic bone formation occurred. There were no clinical sequelae associated with heterotopic bone formation. The mean preoperative and postoperative Oswestry Disability Index was 50.2% (range, 25%-75%) and 11.3% (range, 0%-38%) respectively.. Although the adjunctive use of rhBMP2 is associated with a higher incidence of heterotopic bone, there does not seem to be any associated clinical sequelae.

Topics: Adult; Aged; Back Pain; Bone Morphogenetic Protein 2; Bone Morphogenetic Proteins; Bone Transplantation; Disability Evaluation; Epidural Space; Female; Follow-Up Studies; Humans; Incidence; Lumbar Vertebrae; Male; Middle Aged; Minimally Invasive Surgical Procedures; Ossification, Heterotopic; Pain Measurement; Prospective Studies; Recombinant Proteins; Severity of Illness Index; Spinal Cord Diseases; Spinal Diseases; Spinal Fusion; Time Factors; Tomography, X-Ray Computed; Transforming Growth Factor beta; Treatment Outcome