“…2,4,7,10,16 The data reported in this prospective, randomized, multicenter study support the safety and efficacy of Kineflex|C and add to the growing body of Level I data that are compelling enough to no longer consider CTDR investigational. 13 Patients treated with Kineflex|C showed statistically superior overall clinical outcomes compared with ACDF while maintaining segmental motion.…”
Section: Discussionmentioning
confidence: 82%
“…2,7,25 Therefore, ideally the application of any CTDR device should closely mimic the ease and safety of the ACDF procedure. Intraoperative fluoroscopy is required for any CTDR device, and it generally requires greater attention to detail.…”
ObjectCervical total disc replacement (CTDR) represents a relatively novel procedure intended to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. This prospective, randomized, multicenter study evaluates the safety and efficacy of a new metal-on-metal CTDR implant (Kineflex|C) by comparing it with ACDF in the treatment of single-level spondylosis with radiculopathy.MethodsThe study was a prospective, randomized US FDA Investigational Device Exemption (IDE) pivotal trial conducted at 21 centers across the US. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS) scores, and a composite measure of clinical success. Patients were randomized to CTDR using the Kineflex|C (SpinalMotion, Inc.) cervical artificial disc or ACDF using structural allograft and an anterior plate.ResultsA total of 269 patients were enrolled and randomly assigned to either CTDR (136 patients) or to ACDF (133 patients). There were no significant differences between the CTDR and ACDF groups when comparing operative time, blood loss, length of hospital stay, or the reoperation rate at the index level. The overall success rate was significantly greater in the CTDR group (85%) compared with the ACDF group (71%) (p = 0.05). In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 24-month follow-up (p < 0.0001). Similarly, the VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 24-month follow-up (p < 0.0001). The range of motion (ROM) in the CTDR group decreased at 3 months but was significantly greater than the preoperative mean at 12- and 24-month follow-up. The ROM in the ACDF group was significantly reduced by 3 months and remained so throughout the follow-up. Adjacent-level degeneration was also evaluated in both groups from preoperatively to 2-year follow-up and was classified as none, mild, moderate, or severe. Preoperatively, there were no significant differences between groups when evaluating the different levels of adjacent-level degeneration. At the 2-year follow-up, there were significantly more patients in the ACDF group with severe adjacent-level radiographic changes (p < 0.0001). However, there were no significant differences between groups in adjacent-level reoperation rate (7.6% for the Kineflex|C group and 6.1% for the ACDF group).ConclusionsCervical total disc replacement allows for neural decompression and clinical results comparable to ACDF. Kineflex|C was associated with a significantly greater overall success rate than fusion while maintaining motion at the index level. Furthermore, there were significantly fewer Kineflex|C patients showing severe adjacent-level radiographic changes at the 2-year follow-up. These results from a prospective, randomized study support that Kineflex|C CTDR is a viable alternative to ACDF in select patients with cervical radiculopathy.
“…2,4,7,10,16 The data reported in this prospective, randomized, multicenter study support the safety and efficacy of Kineflex|C and add to the growing body of Level I data that are compelling enough to no longer consider CTDR investigational. 13 Patients treated with Kineflex|C showed statistically superior overall clinical outcomes compared with ACDF while maintaining segmental motion.…”
Section: Discussionmentioning
confidence: 82%
“…2,7,25 Therefore, ideally the application of any CTDR device should closely mimic the ease and safety of the ACDF procedure. Intraoperative fluoroscopy is required for any CTDR device, and it generally requires greater attention to detail.…”
ObjectCervical total disc replacement (CTDR) represents a relatively novel procedure intended to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. This prospective, randomized, multicenter study evaluates the safety and efficacy of a new metal-on-metal CTDR implant (Kineflex|C) by comparing it with ACDF in the treatment of single-level spondylosis with radiculopathy.MethodsThe study was a prospective, randomized US FDA Investigational Device Exemption (IDE) pivotal trial conducted at 21 centers across the US. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS) scores, and a composite measure of clinical success. Patients were randomized to CTDR using the Kineflex|C (SpinalMotion, Inc.) cervical artificial disc or ACDF using structural allograft and an anterior plate.ResultsA total of 269 patients were enrolled and randomly assigned to either CTDR (136 patients) or to ACDF (133 patients). There were no significant differences between the CTDR and ACDF groups when comparing operative time, blood loss, length of hospital stay, or the reoperation rate at the index level. The overall success rate was significantly greater in the CTDR group (85%) compared with the ACDF group (71%) (p = 0.05). In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 24-month follow-up (p < 0.0001). Similarly, the VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 24-month follow-up (p < 0.0001). The range of motion (ROM) in the CTDR group decreased at 3 months but was significantly greater than the preoperative mean at 12- and 24-month follow-up. The ROM in the ACDF group was significantly reduced by 3 months and remained so throughout the follow-up. Adjacent-level degeneration was also evaluated in both groups from preoperatively to 2-year follow-up and was classified as none, mild, moderate, or severe. Preoperatively, there were no significant differences between groups when evaluating the different levels of adjacent-level degeneration. At the 2-year follow-up, there were significantly more patients in the ACDF group with severe adjacent-level radiographic changes (p < 0.0001). However, there were no significant differences between groups in adjacent-level reoperation rate (7.6% for the Kineflex|C group and 6.1% for the ACDF group).ConclusionsCervical total disc replacement allows for neural decompression and clinical results comparable to ACDF. Kineflex|C was associated with a significantly greater overall success rate than fusion while maintaining motion at the index level. Furthermore, there were significantly fewer Kineflex|C patients showing severe adjacent-level radiographic changes at the 2-year follow-up. These results from a prospective, randomized study support that Kineflex|C CTDR is a viable alternative to ACDF in select patients with cervical radiculopathy.
“…2) All patients underwent standard anterior cervical discectomy using a rightsided approach by a single surgeon. Endplate preparation was done with curettage.…”
Clinical and radiological outcomes of cervical interbody fusion using a polyetheretherketone cage filled with PolyBone } (Kyungwon Medical Co., Ltd., Seoul, Korea), beta-tricalcium phosphate material, and autologous iliac bone were retrospectively compared in 47 patients who underwent anterior cervical discectomy and fusion (ACDF) between January 2007 and April 2008. Of these, 23 received iliac bone grafts and 24 received PolyBone. Numeric rating scale and neck disability index were used for clinical outcome assessments. Cervical radiography was performed immediately postoperatively, and at 1, 3, 6, 12, and 24 months postoperatively. Computed tomography (CT) was performed at 12 and 24 months postoperatively. Change in segmental lordosis, disk height, and fusion were compared at 12 and 24 months postoperatively. Clinical outcomes were similar between both groups. CT and radiography at 12 months showed that fusion had occurred in 22 patients in the iliac bone group and in 19 in the PolyBone recipients. Fusion was also identified in 22 patients in both iliac bone and PolyBone groups at 24 months postoperatively. The clinical outcomes of ACDF using PolyBone and iliac bone were similar, with similar cervical interbody fusion rates at 24 months postoperatively. However, the time taken for fusion was apparently longer in the PolyBone group.
“…The ideal device or bone substitute would provide adequate stability and optimized fusion bed, restore disc height and cervical lordosis, preserve the integrity of the vertebral body endplates and must be an atraumatic method as possible. The harvesting bone graft material from the anterior iliac crest is associated with significant short-and long-term morbidity such as infection, pelvic fracture, meralgia paresthetica, wound hematoma, loss of sensation and especially postoperative pain in up to about 20% of cases 3) . And, the quality of the autologous graft material can be a concern in patients with osteoporosis, metabolic disorder, neoplasia, chronic inflammatory disease, infection, and bone fractures of the donor site.…”
Objective : This is retrospective study of clinical and radiological outcomes of anterior cervical fusion using Bongros-HA TM (BioAlpha, Seongnam, Korea) which is a type of synthetic hydroxyapatite (HA) spacer to evaluate the efficacy in its clinical application and usefulness as a reliable alternative to autograft bone. Methods : Twenty-nine patients were enrolled in this study and 40 segments were involved. All patients were performed anterior cervical interbody fusion using HA spacer and plating system. Indications for surgery were radiculopathy caused by soft-disc herniation or spondylosis in 18 patients, spondylotic myelopathy in 1 patient, and spinal trauma in 10 patients. Cervical spine radiographs were obtained on postoperative 1day, 1week, and then at 1, 2, 6, and 12 months in all patients to evaluate intervertebral disc height, and the degrees of lordosis. Cervical computed tomography was done at postoperative 12 month in all patients to confirm the fusion status. The mean period of clinical follow-up was 17 months. Results : Complete interbody fusion was achieved in 100% of patients. Preoperative kyphotic deformities were corrected in all cases after surgery. Intervertebral disc height was well maintained during follow up period. There were no cases of graft extrusion, graft deterioration and graft fracture. Conclusion : HA spacer is very efficient in achieving cervical fusion, maintaining intervertebral disc height, and restoring lordosis. When combined with the placement of a cervical plate, immediate stability can be achieved and graft related complication can be prevented.
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