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P125. Growth rod spinal instrumentation to control progressive early onset scoliosis
170S
Proceedings of the NASS 20th Annual Meeting / The Spine Journal 5 (2005) 1S–189S
BACKGROUND CONTEXT: Anterior cervical discectomy and fusion (ACDF) with an interbody spacer has been the gold standard for the surgical treatment of cervical spondylosis and disc disease. Although the procedure provides significant clinical improvement, cervical arthrodesis has been postulated to exacerbate degeneration of adjacent levels. Cervical total disc arthroplasty is intended to provide symptomatic relief by decompression neural elements and restore motion thereby protecting adjacent levels from the abnormal stresses associated with fusion. PURPOSE: To assess the safety and efficacy of the ProDisc-C prosthesis in treating cervical degenerative disease compared with ACDF at a single level. STUDY DESIGN/SETTING: A multi-center clinical prospective, randomized trial is underway. Patient inclusion criteria for the study included disc herniation, loss of height, or spondylotic changes between C3-7 levels with radiculopathy and/or myelopathy. PATIENT SAMPLE: Currently, 23 patients were surgically treated at this single center, under IRB approval. The groups were equally divided (ACDF⫽12 patients and ProDisc-C group⫽11 patients). OUTCOME MEASURES: Efficacy was assessed by evaluating patients at follow-up by the Neck Disability Index (NDI), SF-12, VAS, and range of motion (ROM). Range of motion was measured using standard radiographic methods. METHODS: Patients are to be assessed preoperatively and postoperatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years. Complications were recorded and stratified based on device related, approach related or postoperative complications. RESULTS: The average age (ProDisc-C⫽39 y.o., ACDF⫽42 y.o.) and average weight (ProDisc-C⫽170 lbs., ACDF⫽169 lbs.) were similar at time of surgery. The operative time (ProDisc-C⫽122⫾17 min, ACDF⫽ 134⫾22.) and blood loss (ProDisc-C⫽95⫾37 ml, ACDF⫽63⫾17 ml) also showed no differences. The VAS scores for neck pain and frequency as well as arm pain and frequency showed no statistical differences between the two treatments. However, both treatments showed marked improvement in radiculopathy versus preoperative state. Postoperative radiographs show restoration of disc height with maintenance of range of motion. There were no intraoperative complications and 1 Prodisc-C (1/23) patient complained of persistent radiculopathy that resolved at 3 months follow-up. CONCLUSIONS: Our current results demonstrate Prodisc-C total disc replacement alleviates pain and improves function based on neurologic symptoms and signs similar to the control ACDF with postoperative radiographs demonstrating motion. Long-term review of dynamic radiographs will be needed to track gross motion preservation as well as incidence of adjacent segment disease and instability. DISCLOSURES: FDA device/drug: ProDisc-C. Status: Investigational/ not approved. CONFLICT OF INTEREST: Author (JAG) Other: Fellowship supportCompany information not available at time of printing; Author (JAG) Grant Research Support: Company information not available at time of printing. doi: 10.1016/j.spinee.2005.05.338 P124. Long adult deformity correction to L5 risk factors for loss of fixation Gary Gonya, MD, Khaled Kebaish, MD, Oliver Perez, MD, Sue Yin Liong, BS; Johns Hopkins University, Baltimore, MD, USA BACKGROUND CONTEXT: Long posterior fusions in adults which ends proximal to the sacrum may be at increased risk for fixation failure. Few studies address the outcomes of long adult deformity correction to L4 or L5 and risk factors for failure. PURPOSE: To assess the outcomes of patients with long fusions to L4 or L5 and determine risk factors for loss of distal fixation. STUDY DESIGN/SETTING: Retrospective clinical and radiographic analysis at one institution. PATIENT SAMPLE: 65 consecutively treated patients fused from the throracic spine to L4 or L5 at a single institution with 2 year minimum follow-up.
OUTCOME MEASURES: Preoperative, postoperaitve and latest followup radiographic analysis and chart review. METHODS: Retrospective chart and xray review. RESULTS: Frank failure developed in 4/31 cases (12.9%) by early postoperative follow-up and in an additional 1/31 cases (3.2%) by last postoperative follow-up. There were no demographic or medical risk factors for frank failure identified. At baseline, sagittal balance angle was 149.8 for frank failure and 44.3 among those who did not develop frank failure. Postoperative decrease in satittal angle was associated with an increase in the likelihood of frank failure (OR⫽1.03, 95% CI:1.00, 1.05, p⫽.056) that approcached statistical significance. CONCLUSIONS: Loss of distal implant fixation in adult deformity ending short of the sacrum in not uncommon (12.9%). DISCLOSURES: No disclosures. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/j.spinee.2005.05.339
P125. Growth rod spinal instrumentation to control progressive early onset scoliosis Tom Ember, MD1, Hilali Noordeen, MD2; 1Great Ormond Street Hospital, London, Surrey, United Kingdom; 2Royal National Orthopaedic Hospital Stanmore, London, Middlesex, United Kingdom BACKGROUND CONTEXT: Subcutaneous rodding with consecutive distractions allows correction of progressive early onset scoliosis that is unresponsive to conservative treatment modalities (usually bracing). The postulated advantage of this technique is the preservation of growth potential of the spinal column by delaying definitive segmental instrumented fusion. The literature is contradictory as to whether the amount of growth achieved justifies the number of procedures required to obtain this. We present a substantial series of patients who are currently undergoing this treatment. The growth rod constructs can take many forms. The construct we have been using comprises two parallel rods (on the curve concavity) linked by a domino. The rods are anchored proximally with hooks and distally with pedicle screws. Sequential distractions are performed across the domino usually every six to nine months. PURPOSE: To assess the use of subcutaneous rodding with sequential lengthening procedures to control progressive early onset curves not responding to conservative treatment modalities. STUDY DESIGN/SETTING: A retrospective study reviewing the notes and plain radiographs of all children with early onset scoliosis treated by growth rod insertion over a three year period (two paediatric spinal surgeons using similar techniques at two major UK Centres). PATIENT SAMPLE: All children with early onset scoliosis unresponsive to conservative management (bracing). OUTCOME MEASURES: Cobb angles of curves at the time of initial instrumentation, curve progression, number of lengthenings, spinal growth achieved and complications encountered. METHODS: Notes and plain radiographs of all children managed in this manner over a four year period (44 cases) were analyzed and a database created for the study outcome measures. RESULTS: Majority of children were treated uneventfully with satisfactory control of curvature. However our results do suggest certain cases (four complications to date) and circumstances where simple growth rod instrumentation is not sufficient and augmentation with anterior apical fusion is required (these will be discussed on an individual basis). CONCLUSIONS: The management of early onset progressive scoliosis by means of growth rod instrumentation and sequential lengthenings at this stage appears safe and effective. DISCLOSURES: No disclosures. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/j.spinee.2005.05.340
Proceedings of the NASS 20th Annual Meeting / The Spine Journal 5 (2005) 1S–189S
BACKGROUND CONTEXT: Anterior cervical discectomy and fusion (ACDF) with an interbody spacer has been the gold standard for the surgical treatment of cervical spondylosis and disc disease. Although the procedure provides significant clinical improvement, cervical arthrodesis has been postulated to exacerbate degeneration of adjacent levels. Cervical total disc arthroplasty is intended to provide symptomatic relief by decompression neural elements and restore motion thereby protecting adjacent levels from the abnormal stresses associated with fusion. PURPOSE: To assess the safety and efficacy of the ProDisc-C prosthesis in treating cervical degenerative disease compared with ACDF at a single level. STUDY DESIGN/SETTING: A multi-center clinical prospective, randomized trial is underway. Patient inclusion criteria for the study included disc herniation, loss of height, or spondylotic changes between C3-7 levels with radiculopathy and/or myelopathy. PATIENT SAMPLE: Currently, 23 patients were surgically treated at this single center, under IRB approval. The groups were equally divided (ACDF⫽12 patients and ProDisc-C group⫽11 patients). OUTCOME MEASURES: Efficacy was assessed by evaluating patients at follow-up by the Neck Disability Index (NDI), SF-12, VAS, and range of motion (ROM). Range of motion was measured using standard radiographic methods. METHODS: Patients are to be assessed preoperatively and postoperatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years. Complications were recorded and stratified based on device related, approach related or postoperative complications. RESULTS: The average age (ProDisc-C⫽39 y.o., ACDF⫽42 y.o.) and average weight (ProDisc-C⫽170 lbs., ACDF⫽169 lbs.) were similar at time of surgery. The operative time (ProDisc-C⫽122⫾17 min, ACDF⫽ 134⫾22.) and blood loss (ProDisc-C⫽95⫾37 ml, ACDF⫽63⫾17 ml) also showed no differences. The VAS scores for neck pain and frequency as well as arm pain and frequency showed no statistical differences between the two treatments. However, both treatments showed marked improvement in radiculopathy versus preoperative state. Postoperative radiographs show restoration of disc height with maintenance of range of motion. There were no intraoperative complications and 1 Prodisc-C (1/23) patient complained of persistent radiculopathy that resolved at 3 months follow-up. CONCLUSIONS: Our current results demonstrate Prodisc-C total disc replacement alleviates pain and improves function based on neurologic symptoms and signs similar to the control ACDF with postoperative radiographs demonstrating motion. Long-term review of dynamic radiographs will be needed to track gross motion preservation as well as incidence of adjacent segment disease and instability. DISCLOSURES: FDA device/drug: ProDisc-C. Status: Investigational/ not approved. CONFLICT OF INTEREST: Author (JAG) Other: Fellowship supportCompany information not available at time of printing; Author (JAG) Grant Research Support: Company information not available at time of printing. doi: 10.1016/j.spinee.2005.05.338 P124. Long adult deformity correction to L5 risk factors for loss of fixation Gary Gonya, MD, Khaled Kebaish, MD, Oliver Perez, MD, Sue Yin Liong, BS; Johns Hopkins University, Baltimore, MD, USA BACKGROUND CONTEXT: Long posterior fusions in adults which ends proximal to the sacrum may be at increased risk for fixation failure. Few studies address the outcomes of long adult deformity correction to L4 or L5 and risk factors for failure. PURPOSE: To assess the outcomes of patients with long fusions to L4 or L5 and determine risk factors for loss of distal fixation. STUDY DESIGN/SETTING: Retrospective clinical and radiographic analysis at one institution. PATIENT SAMPLE: 65 consecutively treated patients fused from the throracic spine to L4 or L5 at a single institution with 2 year minimum follow-up.
OUTCOME MEASURES: Preoperative, postoperaitve and latest followup radiographic analysis and chart review. METHODS: Retrospective chart and xray review. RESULTS: Frank failure developed in 4/31 cases (12.9%) by early postoperative follow-up and in an additional 1/31 cases (3.2%) by last postoperative follow-up. There were no demographic or medical risk factors for frank failure identified. At baseline, sagittal balance angle was 149.8 for frank failure and 44.3 among those who did not develop frank failure. Postoperative decrease in satittal angle was associated with an increase in the likelihood of frank failure (OR⫽1.03, 95% CI:1.00, 1.05, p⫽.056) that approcached statistical significance. CONCLUSIONS: Loss of distal implant fixation in adult deformity ending short of the sacrum in not uncommon (12.9%). DISCLOSURES: No disclosures. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/j.spinee.2005.05.339
P125. Growth rod spinal instrumentation to control progressive early onset scoliosis Tom Ember, MD1, Hilali Noordeen, MD2; 1Great Ormond Street Hospital, London, Surrey, United Kingdom; 2Royal National Orthopaedic Hospital Stanmore, London, Middlesex, United Kingdom BACKGROUND CONTEXT: Subcutaneous rodding with consecutive distractions allows correction of progressive early onset scoliosis that is unresponsive to conservative treatment modalities (usually bracing). The postulated advantage of this technique is the preservation of growth potential of the spinal column by delaying definitive segmental instrumented fusion. The literature is contradictory as to whether the amount of growth achieved justifies the number of procedures required to obtain this. We present a substantial series of patients who are currently undergoing this treatment. The growth rod constructs can take many forms. The construct we have been using comprises two parallel rods (on the curve concavity) linked by a domino. The rods are anchored proximally with hooks and distally with pedicle screws. Sequential distractions are performed across the domino usually every six to nine months. PURPOSE: To assess the use of subcutaneous rodding with sequential lengthening procedures to control progressive early onset curves not responding to conservative treatment modalities. STUDY DESIGN/SETTING: A retrospective study reviewing the notes and plain radiographs of all children with early onset scoliosis treated by growth rod insertion over a three year period (two paediatric spinal surgeons using similar techniques at two major UK Centres). PATIENT SAMPLE: All children with early onset scoliosis unresponsive to conservative management (bracing). OUTCOME MEASURES: Cobb angles of curves at the time of initial instrumentation, curve progression, number of lengthenings, spinal growth achieved and complications encountered. METHODS: Notes and plain radiographs of all children managed in this manner over a four year period (44 cases) were analyzed and a database created for the study outcome measures. RESULTS: Majority of children were treated uneventfully with satisfactory control of curvature. However our results do suggest certain cases (four complications to date) and circumstances where simple growth rod instrumentation is not sufficient and augmentation with anterior apical fusion is required (these will be discussed on an individual basis). CONCLUSIONS: The management of early onset progressive scoliosis by means of growth rod instrumentation and sequential lengthenings at this stage appears safe and effective. DISCLOSURES: No disclosures. CONFLICT OF INTEREST: No conflicts. doi: 10.1016/j.spinee.2005.05.340