James J. Yue

STUDY DESIGN: A prospective, randomized, multicenter, Food and Drug Administration-regulated Investigational Device Exemption clinical trial. OBJECTIVE: To evaluate the safety and effectiveness of the ProDisc-L (Synthes Spine, West Chester, PA) lumbar total disc replacement compared to circumferential spinal fusion for the treatment of discogenic pain at 1 vertebral level between L3 and S1. SUMMARY OF BACKGROUND DATA: As part of the Investigational Device Exemption clinical trial, favorable single center results of lumbar total disc replacement with the ProDisc-L have been reported previously. METHODS: Two hundred eighty-six (286) patients were treated on protocol. Patients were evaluated before and after surgery, at 6 weeks, 3, 6, 12, 18, and 24 months. Evaluation at each visit included patient self-assessments, physical and neurologic examinations, and radiographic evaluation. RESULTS: Safety of ProDisc-L implantation was demonstrated with 0% major complications. At 24 months, 91.8% of investigational and 84.5% of control patients reported improvement in the Oswestry Low Back Pain Disability Questionnaire (Oswestry Disability Index [ODI]) from preoperative levels, and 77.2% of investigational and 64.8% of control patients met the > or =15% Oswestry Disability Index improvement criteria. Overall neurologic success in the investigational group was superior to the control group (91.2% investigational and 81.4% control; P = 0.0341). At 6 weeks and 3 months follow-up time points, the ProDisc-L patients recorded SF-36 Health Survey scores significantly higher than the control group (P = 0.018, P = 0.0036, respectively). The visual analog scale pain assessment showed statistically significant improvement from preoperative levels regardless of treatment (P < 0.0001). Visual analog scale patient satisfaction at 24 months showed a statistically significant difference favoring investigational patients over the control group (P = 0.015). Radiographic range of motion was maintained within a normal functional range in 93.7% of investigational patients and averaged 7.7 degrees. CONCLUSIONS: ProDisc-L has been found to be safe and efficacious. In properly chosen patients, ProDisc-L has been shown to be superior to circumferential fusion by multiple clinical criteria.

In Brief Study Design. Prospective, longitudinal minimum 2-year follow-up. Objective. To assess the efficacy and safety of the Prodisc implant in patients with disabling single-level discogenic low back pain (LBP). Summary of Background Data. The treatment of debilitating discogenic LBP has been controversial and varied. To date, a longitudinal prospective study of the treatment of single-level incapacitating discogenic LBP using the Prodisc total disc arthroplasty technique has not been described. Methods. A prospective analysis was performed on 118 patients treated with single-level lumbar Prodisc total disc arthroplasty. Patients 18 to 60 years of age with disabling and recalcitrant discogenic LBP with or without radicular pain secondary to single-level discogenic LBP from L3 to S1 were included. Patients were assessed before surgery, and outcome measurements were after surgery administered at 3, 6, 12, and 24 months. Results. A total of 104 patients (88%) fulfilled all follow-up criteria. The median age of all patients was 47 years (range, 36–60 years). Statistical improvements in VAS, Oswestry, and patient satisfaction scores occurred 3 months postoperatively. These improvements were maintained at the 24-month follow-up. Radicular pain also decreased significantly. Full-time and part-time work rates increased from 10% to 35% and 3% to 24%, respectively. No additional fusion surgeries were necessary either at the affected or unaffected levels. Radiographic analysis revealed an affected disc height increase from 4 mm to 13 mm (P < 0.001) and an affected disc motion from 3° to 7° (P < 0.004). Conclusions. Single-level Prodisc lumbar total disc arthroplasty is a safe and efficacious treatment method for debilitating lumbar discogenic LBP. Significant improvements in patient satisfaction and disability scores occurred after surgery by 3 months and were maintained at the 2-year follow-up. No device-related complications occurred. Patients with severe to moderate disc height loss as well as those with symptomatic posterior anular defects with minimal disc height loss achieve functional gains and significant pain relief. Careful and appropriate patient selection is essential in ensuring optimal surgical outcomes. The treatment of debilitating discogenic low back pain has been controversial and varied. The purpose of this study is to assess the efficacy and safety of the Prodisc implant in patients with disabling single-level discogenic low back pain. Single-level Prodisc lumbar total disc arthroplasty is a safe and efficacious treatment method for debilitating lumbar spondylosis without significant facet arthropathy. In our analysis, statistically significant improvement in patient satisfaction and disability scores occurred after surgery in 96% of patients by 3 months and were maintained at the 2-year follow-up. No device-related complications occurred.

OBJECT: Cervical anterior decompression and total-disc replacement is currently being investigated as an alternative treatment in patients with symptomatic intervertebral cervical spondylosis with and without radiculopathy. The authors prospectively investigated the safety and efficacy of using the ProDisc-C disc for cervical arthroplasty in the treatment of symptomatic cervical spondylosis. METHODS: Sixteen patients in whom a diagnosis of symptomatic cervical spondylosis had been established were prospectively treated with complete anterior cervical discectomy and ProDisc-C cervical disc arthroplasty. Overall 12 single- and four two-level procedures were performed (20 prostheses). Patients underwent pre- and multiple postoperative assessments (3 and 6 weeks and 3, 6, and 12 months). The median age of all patients was 50 years (range 32-60 years). Levels of surgery included seven C5-6, six C6-7, and three C4-5. Neck and arm pain as well as disability scores were significantly improved by 3 months and remained significantly improved at 1 year. No additional fusion surgeries were necessary at the affected or unaffected levels. Radiography revealed an affected disc motion from 4 to 12 degrees. No surgery- or device-related complications were documented. CONCLUSIONS: Analysis of preliminary results involving ProDisc-C arthroplasty indicates significant improvement in pain and functional outcome scores. No spontaneous fusions at the level of surgery or at adjacent levels were noted. Long-term follow-up studies will be necessary before more definitive treatment recommendations can be formulated.

STUDY DESIGN: The treatment of unstable thoracic spine fractures remains controversial. Theoretical biomechanical advantages of transpedicular screw fixation include three-column control of vertebral segments and fixation of a vertebral segment in the absence of intact posterior elements. Additionally, pedicle screw constructs may obviate the need for neural canal dissection and potential neural element impingement by intracanal instrumentation. A 3-year consecutive series was performed to evaluate the use of transpedicular screw fixation in the treatment of unstable thoracic spine injuries. OBJECTIVE: This study was performed to evaluate the efficacy of transpedicular screw fixation in the upper, middle, and lower thoracic spine. SUMMARY OF BACKGROUND DATA: The use of rod/hook and rod/wiring techniques has been evaluated in the treatment of thoracic spine injuries. To date, a study evaluating the safety and efficacy of pedicle screw instrumentation in the upper, middle, and lower thoracic spine has not been reported. METHODS: Thirty-two patients with 79 individual vertebral injury levels (T2-L1) treated with transpedicular spinal stabilization and bone fusion were evaluated during a 3-year consecutive series from 1998 to 2001. Patient charts, operative reports, preoperative and postoperative radiographs, computed tomography scans, and postoperative follow-up examinations and radiographs were reviewed from the time of surgery to final follow-up assessment. Radiographic measurements included: sagittal index, Gardner segmental kyphotic deformity, and compression percentage. RESULTS: A total of 252 pedicle screws were placed, of which 222 were placed in segments T2-L1. Clinical examination and plain radiographs were used to determine the presence of a solid fusion. Fracture healing and radiographic stabilization occurred at an average of 4.8 months after the initial operation. There were no reported cases of hardware failure, loss of reduction, or painful hardware removal. Two hundred fifty-two transpedicular screws were successfully placed without intraoperative complications. The mean preoperative sagittal index was 13.9 degrees, whereas the mean follow-up was 5.25 degrees (P < 0.001). The mean final correction of sagittal index achieved was 8.65 degrees, or a 62.2% improvement. The mean Gardner segmental kyphotic angle was 15.9 degrees, whereas the mean follow-up angle was 10.6 degrees (P < 0.0005). The mean compression percentage was 35.4, and at follow-up was 27.4 (P < 0.07). CONCLUSIONS: In carefully selected instances, pedicle screw fixation of upper, middle, and lower thoracic and upper thoracolumbar spinal injuries is a reliable and safe method of posterior spinal stabilization. Transpedicular screw fixation may offer superior three-column control in the absence of posterior element integrity and obviates the need for intracanal placement of hardware. Transpedicular instrumentation provides rigid fixation for upper, middle, and lower unstable thoracic spine injuries and produces early pain-free fusion results. These results provide evidence that with appropriate preoperative radiographic evaluation of pedicular size and orientation using computed tomography as well as radiograph assessment, transpedicular instrumentation is a safe and effective alternative in the treatment of unstable thoracic (T2-L1) spinal injuries.

STUDY DESIGN: An in vitro human cadaveric biomechanical study. OBJECTIVES: To evaluate intervertebral rotation changes due to lumbar ProDisc-L compared with simulated fusion, using follower load and multidirectional testing. SUMMARY OF BACKGROUND DATA: Artificial discs, as opposed to the fusions, are thought to decrease the long-term accelerated degeneration at adjacent levels. A biomechanical assessment can be helpful, as the long-term clinical evaluation is impractical. METHODS: Six fresh human cadaveric lumbar specimens (T12-S1) underwent multidirectional testing in flexion-extension, bilateral lateral bending, and bilateral torsion using the Hybrid test method. First, intact specimen total range of rotation (T12-S1) was determined. Second, using pure moments again, this range of rotation was achieved in each of the 5 constructs: A) ProDisc-L at L5-S1; B) fusion at L5-S1; C) ProDisc-L at L4-L5 and fusion at L5-S1; D) ProDisc-L at L4-L5 and L5-S1; and E) 2-level fusion at L4-L5 to L5-S1. Significant changes in the intervertebral rotations due to each construct were determined at the operated and nonoperated levels using repeated measures single factor ANOVA and Bonferroni statistical tests (P < 0.05). Adjacent-level effects (ALEs) were defined as the percentage changes in intervertebral rotations at the nonoperated levels due to the constructs. RESULTS: One- and 2-level ProDisc-L constructs showed only small ALE in any of the 3 rotations. In contrast, 1- and 2-level fusions showed increased ALE in all 3 directions (average, 7.8% and 35.3%, respectively, for 1 and 2 levels). In the disc plus fusion combination (construct C), the ALEs were similar to the 1-level fusion alone. CONCLUSIONS: In general, ProDisc-L preserved physiologic motions at all spinal levels, while the fusion simulations resulted in significant ALE.