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Objective: To evaluate the effectiveness of Coflex interspinous dynamic internal fixation combined with spinal fusion for lumbar disc degeneration. Methods: The clinical data of 39 patients with two-level lumbar disc degeneration who met the selection criteria between June 2010 and December 2011 was retrospectively analyzed. They were divided into group A (20 cases, simple lumbar decompression and fusion) and group B (19 cases, Coflex interspinous dynamic internal fixation combined with spinal fusion) according to different surgical methods. There was no significant difference in age, gender, disease diagnosis, lesion segment, disease duration, Oswestry disability index (ODI), visual analogue scale (VAS) score, and the intervertebral height, foramen intervertebral height (FIH), and range of motion (ROM) of upper operative segment and adjacent segment between the two groups ( P>0.05). ODI and VAS score were used to evaluate the effectiveness before operation and at last follow-up, and the improvement rates were calculated. The intervertebral height [anterior disc height (ADH), middle disc height (MDH), and posterior disc height (PDH)], FIH, and ROM were measured and compared between the two groups. Results: The operation time and intraoperative blood loss in group A were significantly more than those in group B ( P0.05); the improvement rate of VAS score in group B was significantly higher than that in group A ( t=2.245, P=0.031). There was no significant difference in the intervertebral height and FIH of the upper operative segment at last follow-up between the two groups and between preoperation and last follow-up in the two groups ( P>0.05). At last follow-up, the ADH of adjacent segment in group B was significantly higher than that in group A, and MDH, PDH, and FIH were significantly lower than those in group A ( P0.05). The ROM of adjacent segment in group A increased significantly at last follow-up ( t=2.318, P=0.026). There was significant difference in ROM of adjacent segment between the two groups ( P<0.05). Conclusion: The mid-term effectiveness of Coflex interspinous dynamic internal fixation combined with spinal fusion is similar to that of simple decompression fusion. For those patients whose adjacent segments of the responsible segments have degeneration but have no symptoms or mild symptoms, this treatment can slow down the adjacent segment degeneration.
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Resumen: Introducción: Estudio prospectivo en pacientes afectos de hernia discal lumbar L5 S1 tratados mediante la U-Force interespinosa N6. El espaciador interespinoso denominado "U" está realizado en titanio y es colocado entre las apófisis interespinosas. Material y métodos: 50 pacientes operados de hernia discal lumbar fueron evaluados; 25 pertenecían al grupo U-N6 y 25 sólo fueron tratados con microcirugía. Se les realizó valoración clínica y estudios radiológicos seriados. Todos los individuos tuvieron un seguimiento durante dos años (2013-2014). Resultados: Nuestro estudio revela que el uso del dispositivo fue más efectivo (estadísticamente significativo) para el retraso de la inestabilidad que sólo la técnica quirúrgica (p < 0.01). Permitió su colocación en 90% de los sujetos. Conclusión: El uso de este dispositivo retrasa el colapso vertebral y, por ende, la inestabilidad del segmento operado. Noventa por ciento de los casos del grupo N6 presentan el dispositivo a nivel de L5 S1 versus 60% del grupo histórico con otros dispositivos (2004-2011).
Abstract: Introduction: We conducted a retrospective study in patients with disc herniation and compared the results obtained in individuals treated with the U device N6 with those acquired in patients treated without any device. The U device is a titanium alloy implant that is placed between the spinous processes. Material and methods: In a cohort of 50 patients with degenerative lumbar disc, 25 underwent surgical treatment in which the U device was placed and 25 control individuals were treated with discectomy alone. Patients underwent serial follow-up evaluations, and radiographic assessment was used to determine the outcome. Up to two years of follow-up data were obtained in all patients (2013-2014). Results: Statistically significant improvement was seen in patients treated with the coflex device in the management of lumbar disc degeneration to avoid lumbar instability in the future (p < 0.01). It allowed its placement in 90% of the patients. Conclusions: Our study shows that the coflex device was more effective than the discectomy group in the management of lumbar instability. Ninety percent of the cases of the N6 group present the device at L5 S1 versus 60% of the historical group with other devices (2004-2011).
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STUDY DESIGN: Prospective cohort study. PURPOSE: To assess whether additional implantation of Coflex following spinal decompression provided better clinical outcomes compared to decompression alone for symptomatic lumbar spinal stenosis (LSS) and to determine whether improvement in clinical outcomes correlated with changes in the radiological indices studied. OVERVIEW OF LITERATURE: Literature on benefits of additional Coflex implantation compared to decompression alone for symptomatic LSS is limited. METHODS: Patients with symptomatic LSS who met the study criteria were offered spinal decompression with Coflex implantation. Those patients who accepted Coflex implantation were placed in the Coflex group (n=22); while those opting for decompression alone, were placed in the comparison group (n=24). Clinical outcomes were assessed preoperatively, six-months, one-year and two-years postoperatively, using the Oswestry disability index, 100 mm visual analogue scale (VAS)-back pain and VAS-leg pain, and short form-36 (SF-36). Radiological indices (disc height, foraminal height and sagittal angle) were assessed preoperatively, six months, one year, and two years postoperatively. RESULTS: Both groups showed statistically significant (p<0.001) improvement in all the clinical outcome indicators at all points in time as compared to the preoperative status. However, improvement in the Coflex group was significantly greater (p<0.001) than the comparison group. Changes in the radiological indices did not correlate significantly with the improvement in clinical outcome indicators. CONCLUSIONS: Additional Coflex implantation after spinal decompression in symptomatic LSS offers better clinical outcomes than decompression alone in the short-term. Changes in radiological indices do not correlate with the improvements in clinical outcomes after surgery for symptomatic LSS.
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Humans , Cohort Studies , Decompression , Prospective Studies , Spinal StenosisABSTRACT
Objective To simulate clinical operation and investigate feasibility of Coflex dynamic device for fixing L5/S1 segment of lower lumbar degenerative diseases. Methods The lower lumbar-sacral digital model was extracted from platform of the second generation of Chinese Digitized Human “Male No.23” data set, and three finite element (FE) models (the model of normal lower lumbar sacrum, L4/5 and L5/S1 segment fixed with Coflex) were developed respectively using a series of CAX software. According to the spinal three-column loading theory and the lower lumbar physiological behaviors, FE model tests were analyzed, validated and compared under the physiological load of upright standing, anteflexion and extension. Results The FE models of normal lower lumbar sacrum (Healthy), Coflex fixed-L4/5 segment (L4/5), Coflex fixed-L5/S1 segment (L5/S1) were developed, respectively. Based on biomechanical indexes (stability and compatibility) of the controlled trial for the FE model, the two Coflex-fixed FE models showed similar biomechanical effects for fixing the lower lumbar. Conclusions The controlled trials of FE models provide biomechanical evidence for the fixation of lower lumbar L5/S1 segment by Coflex dynamic device, which is of significance for application of Coflex in fixing L5/S1 segment in clinic.
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Objective To explore the efficacy and safety of coflex interspinous dynamic fixation device implantation in the lumbar spinal stenosis. Methods Eighty-three patients with lumbar spinal stenosis were randomly divided into two groups, and 80 cases were followed up. Coflex group (38 patients) received coflex implantation,posterior lumbar interbody fusion (PLIF) group(42 patients) received PLIF treatment. Indicators of surgical trauma degree (operation time, blood loss volume, wound drainage volume within 48 hours, incision pain (VAS) score after surgery 3 days,postoperative ambulation time),indicators of clinical effect (waist and leg pain VAS scores,Japan Orthopaedic Association JOA score,Oswestry functional disability index ODI score),intervertebral space height and median sagittal diameter (MSO) were measured and compared between the two groups. Results In the Coflex group, the operation time, blood loss volume, wound drainage volume within 48 hours, incision pain (VAS) score after surgery 3 days,postoperative ambulation time were (104.3 ±9.5) min,(230. 7 ±29.6) ml,(110. 6 ±34. 5)ml,3. 2 ±1.3, (13. 6 ±2.0) d,which were significantly lower than those of (174. 6 ±24. 2) min,(536. 8 ±163.3) ml, (319. 2 ± 142. 8) ml,4. 8 ±2. 7, (15. 7 ±2. 6) d in the PLIF group(t= 16. 720,11. 380,8. 771,3. 320,4.018,Ps 0. 05) on severe complications such as internal fixation loosening and spinous process fractures.Conclusion The two surgical methods both can effectively increase the foraminal area and intervertebral height to maintain the stability of the spinal posterior colum. However, Coflex interspinous dynamic fixation device implantation had more advantages,such as shorter operation time,less bleeding,less trauma,and early functional exercises.
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OBJECTIVE: Clinical and radiological results of posterior dynamic stabilization using interspinous U (ISU, Coflex(TM), Paradigm Spine Inc.(R), NY, USA) were analyzed in comparison with posterior lumbar interbody fusion (PLIF) in degenerative lumbar spinal stenosis (LSS). METHODS: A retrospective study was conducted for a consecutive series of 61 patients with degenerative LSS between May 2003 and December 2005. We included only the patients completed minimum 24 months follow up evaluation. Among them, 30 patients were treated with implantation of ISU after decompressive laminectomy (Group ISU) and 31 patients were treated with wide decompressive laminectomy and posterior lumbar interbody fusion (PLIF; Group PLIF). We evaluated visual analogue scale (VAS) and Oswestry Disability Index (ODI) for clinical outcomes (VAS, ODI), disc height ratio disc height (DH), disc height/vertebral body length x100), static vertebral slip (VS) and depth of maximal radiolucent gap between ISU and spinous process) in preoperative, immediate postoperative and last follow up. RESULTS: The mean age of group ISU (66.2 +/- 6.7 years) was 6.2 years older than the mean age of group PLIF (60.4 +/- 8.1 years; p = 0.003 ). In both groups, clinical measures improved significantly than preoperative values (p 18.6 +/- 5.9%), however decreased significantly in last follow up (13.8 +/- 6.6%, p = 0.027). Vertebral slip (VS) of spondylolisthesis in group ISU increased during postoperative follow-up (2.3 +/- 3.3 --> 8.7 +/- 6.2, p = 0.040). Meanwhile, the postoperatively improved DH and VS was maintained in group PLIF in last follow up. CONCLUSION: According to our result, implantation of ISU after decompressive laminectomy in degenerative LSS is less invasive and provides similar clinical outcome in comparison with the instrumented fusion. However, the device has only transient effect on the postoperative restoration of disc height and reduction of slip in spondylolisthesis. Therefore, in the biomechanical standpoint, it is hard to expect that use of Interspinous U in decompressive laminectomy for degenerative LSS had long term beneficial effect.
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Humans , Follow-Up Studies , Laminectomy , Postoperative Period , Retrospective Studies , Spinal Stenosis , Spine , SpondylolisthesisABSTRACT
[Objective]To compare the short term outcome in treatment of degenerative lumbar stenosis with Coflex implant versus laminectomy and posterior interbody fusion along with pedicle screw system. [Methods]Thirty patients with degenerative lumbar stenosis were randomly divided into two groups.Fifteen patients in the control group were treated with laminectomy and posterior interbody fusion along with pedicle screw system. The other 15 patients in the experiment group were treated with Coflex implant. The parameters for assessment included operation time,intraoperative blood loss,hospital stay,pre- and postoperative JOA score,improvement rate and complication rate.[Results]Compared to the control,significant reduction was found in terms of operation time,intraoperative blood loss,and hospital stay in the experiment group.No significant difference was found regard to the improvement rate and postoperative JOA score. In addition ,there was no complication in the Coflex group during the follow-up.[Conclusion]Coflex implant is an effective,save and minimally invasive surgical method for the treatment of degenerative lumbar stenosis.