George H. Thompson

Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management

Study Design. Literature review. Objective. To establish consistent parameters for future adolescent idiopathic scoliosis bracing studies so that valid and reliable comparisons can be made. Summary of Background Data. Current bracing literature lacks consistency for both inclusion criteria and the definitions of brace effectiveness. Methods. A total of 32 brace treatment studies and the current bracing in adolescent idiopathic scoliosis proposal were analyzed to: (1) determine inclusion criteria that will best identify those patients most at risk for progression, (2) determine the most appropriate definitions for bracing effectiveness, and (3) identify additional variables that would provide valuable information. Results. Early brace studies lacked clarity in their inclusion criteria. In more recent studies, inclusion criteria have narrowed considerably to include primarily those patients most at risk for curve progression who may benefit from the use of a brace. Brace effectiveness was usually defined by various degrees of curve progression at maturity. Less frequently, it was defined by the resultant curve magnitude at maturity, whether or not surgical intervention was needed, or if there was change to another brace. Conclusions. Optimal inclusion criteria for future adolescent idiopathic scoliosis brace studies consist of: age is 10 years or older when brace is prescribed, Risser 0−2, primary curve angles 25°−40°, no prior treatment, and, if female, either premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness should include: (1) the percentage of patients who have ≤5° curve progression and the percentage of patients who have ≥6° progression at maturity, (2) the percentage of patients with curves exceeding 45° at maturity and the percentage who have had surgery recommended/undertaken, and (3) 2-year follow-up beyond maturity to determine the percentage of patients who subsequently undergo surgery. All patients, regardless of subjective reports on compliance, should be included in the results (intent to treat).Every study should provide results stratified by curve type and size grouping.

Complications of growing-rod treatment for early-onset scoliosis: analysis of one hundred and forty patients.

BACKGROUND Previous reports have indicated high complication rates associated with non-fusion surgery in patients with early-onset scoliosis. This study was performed to evaluate the clinical and radiographic complications associated with growing-rod treatment. METHODS Data from the multicenter Growing Spine Study Group database were evaluated. Inclusion criteria were growing-rod treatment for early-onset scoliosis and a minimum of two years of follow-up. Patients were divided into treatment groups according to rod type (single or dual) and rod location (subcutaneous or submuscular). Complications were categorized as wound, implant, alignment, and general (surgical or medical). Surgical procedures were classified as planned and unplanned. RESULTS Between 1987 and 2005, 140 patients met the inclusion criteria and underwent a total of 897 growing-rod procedures. The mean age at the initial surgery was six years, and the mean duration of follow-up was five years. Eighty-one (58%) of the 140 patients had a minimum of one complication. Nineteen (27%) of the seventy-one patients with a single rod had unplanned procedures because of implant complications, compared with seven (10%) of the sixty-nine patients with dual rods (p ≤ 0.05). Thirteen (26%) of the fifty-one patients with subcutaneous rod placement had wound complications compared with nine of the eighty-eight patients (10%) with submuscular rod placement (p ≤ 0.05). The patients with subcutaneous dual rods had more wound complications, more prominent implants, and more unplanned surgical procedures than did those with submuscular dual rods (p ≤ 0.05). The risk of complications occurring during the treatment period decreased by 13% for each year of increased patient age at the initiation of treatment. The complication risk increased by 24% for each additional surgical procedure performed. CONCLUSIONS Regardless of treatment modality, the management of early-onset scoliosis is prolonged; therefore, complications are frequent and should be expected. Complications can be reduced by delaying initial implantation of the growing rods if possible, using dual rods, and limiting the number of lengthening procedures. Submuscular placement reduces wound and implant-prominence complications and reduces the number of unplanned operations.

Comparison of single and dual growing rod techniques followed through definitive surgery: a preliminary study.

Study Design. Retrospective analysis of patients treated with single and dual growing rods who had completed their course of treatment, had definitive fusion, and had a minimum of 2 years follow-up. Objectives. To determine which technique was the most effective in the management of severe spinal deformity in young children: control of the spinal deformity, spinal growth, and the incidence of complications. Summary of Background Data. Growing rod techniques provide proximal and distal segmental “claw” foundations, but their overall results through definitive fusion have not been clearly determined. Methods. A total of 28 consecutive patients who had growing rod procedures followed through definitive spinal fusions were analyzed. There were three patient groups: Group 1 (N = 5), single submuscular rod and short apical fusion; Group 2 (N = 16), single growing rod alone; and Group 3 (N = 7), dual growing rods. Results. The interval between initial rod insertion and definitive spinal fusion was similar in all three groups. The best overall results occurred in Group 3, whereas the patients in Group 1 had the worse results. Both Groups 2 and 3 provided good initial correction of the spinal deformity and allowed spinal growth. Group 2 had better frontal and sagittal plane balance and the lowest complication rate. Conclusion. The use of growing rods is effective in controlling severe spinal deformities and allowing spinal growth. Dual rods are stronger than single rods and, therefore, provide better initial correction and maintenance of correction. The use of an apical fusion does not appear to be effective over the course of treatment.

Growing Rod Techniques in Early-onset Scoliosis

Background The surgical treatment of severe early-onset scoliosis (EOS) is controversial. Obtaining and maintaining deformity correction, achieving adequate spinal growth, allowing lung development, and the high complication rate make surgical treatment very challenging. Growing rods are the most common method of management. Methods Currently, there are 3 systems being used for the surgical treatment of EOS: single growing rod, dual growing rods, and the vertical expandable titanium prosthetic rib implant. Each system has its advantages and disadvantages. These are presented and discussed in this review. Results The current clinical and radiographic results indicate that all 3 techniques can be effective in the surgical management of EOS. Vertical expandable prosthetic titanium rib (VEPTR), which is not considered a true growing rod system, is particularly effective in congenital scoliosis with fused ribs. Conclusions The current expandable spinal implant systems appear effective in controlling progressive EOS, allowing for spinal growth and improving lung development. All have a moderate complication rate, especially rod breakage and hook displacement.

The Effect of Amicar on Perioperative Blood Loss in Idiopathic Scoliosis:: The Results of a Prospective, Randomized Double-blind Study

Study Design. A prospective, randomized, double-blind Institutional Review Board-approved study evaluating the efficacy of Amicar (epsilon aminocaproic acid), an antifibrinolytic agent, in decreasing perioperative blood loss in idiopathic scoliosis. Objectives. To compare the perioperative (intraoperative and postoperative) blood loss and the need for autologous and homologous blood replacement in two groups of essentially identical patients undergoing a posterior spinal fusion for idiopathic scoliosis. Summary of Background Data. Reducing perioperative blood loss and the need for transfusion in patients undergoing spinal surgery is important to orthopedic surgeons. Recently, there has been interest in pharmacologic agents, particularly Amicar and Aprotinin, to assist in decreasing perioperative blood loss. In 2001, in a preliminary study, we demonstrated that Amicar appeared to be effective in reducing perioperative blood loss in patients with idiopathic scoliosis undergoing a posterior spinal fusion and segmental spinal instrumentation. This was a study of 28 consecutive patients receiving Amicar compared to a historical control group of the 31 previous consecutive patients with the same study criteria. The current study was performed to confirm our preliminary findings. Methods. We analyzed the perioperative blood loss of 36 patients with idiopathic scoliosis who were blindly randomized by the operating room pharmacy into an Amicar and control group. The criteria to be included in the study was the same as the preliminary study: diagnosis of idiopathic scoliosis, age at surgery 11 to 18 years, posterior spinal fusion and segmental spinal instrumentation only, autogenous iliac crest bone graft or homologous cancellous bone graft, and a signed agreement to participate in the study. The patients in both groups had the same anesthetic technique, intraoperative procedure, instrumentation, postoperative management, and standardized indications for transfusions. Results. Before surgery, the patients in both groups were essentially identical. The distribution of patients and their results was not known until the completion of the study. Patients in the Amicar group demonstrated a statistically significant decrease in perioperative blood loss and the need for autologous blood transfusion. Interestingly, this decrease was predominantly in the postoperative suction drainage. This may be due to elevated fibrinogen levels induced by Amicar. The patients taking Amicar had no intraoperative or postoperative thromboembolic complications. Conclusions. The results of this study confirmed that the use of intraoperative Amicar is a safe, effective, and inexpensive method to significantly reduce perioperative blood loss in patients with idiopathic scoliosis undergoing posterior spinal fusion and segmental spinal instrumentation. The results have allowed us to reduce our recommendation for perioperative autologous blood donation, thereby further decreasing costs.

The Effect of ε-Aminocaproic Acid on Perioperative Blood Loss in Patients With Idiopathic Scoliosis Undergoing Posterior Spinal Fusion : A Preliminary Prospective Study

Study Design. A prospective study evaluating the efficacy of &egr;-aminocaproic acid (EACA) in decreasing perioperative blood loss in idiopathic scoliosis. Objectives. To compare the perioperative blood loss and need for blood replacement in two groups of patients undergoing surgery for idiopathic scoliosis. One group received intraoperative EACA; the other did not and served as controls. Summary of Background Data. Excessive blood loss increases the operative time, risk for blood product disease transmission, postoperative complications, and costs associated with posterior spinal fusion and instrumentation. EACA is an antifibrinolytic agent that has been shown to be effective in reducing perioperative blood loss during pediatric cardiothoracic surgical procedures. We hypothesized that it would also be effective in lowering blood loss during posterior spinal fusion for idiopathic scoliosis. Methods. We compared the perioperative blood loss of 28 consecutive pediatric patients with idiopathic scoliosis who underwent posterior spinal fusion and received intraoperative EACA with 31 consecutive patients who did not receive this medication and served as a control group. Results. The patients in both groups were similar. Patients in the EACA group demonstrated statistically significant decreases in total estimated perioperative blood loss and the need for autologous blood transfusion. The patients in the EACA group had no intraoperative or postoperative complications related to the use of this medication. Conclusions. Based on these preliminary findings, we believe that EACA is helpful in decreasing blood loss in patients undergoing posterior spinal fusion and instrumentation, and may decrease the number of autologous units needed to maintain safe perioperative hemoglobin levels, thereby improving safety and lowering cost associated with scoliosis surgery.

Growing rod fractures: risk factors and opportunities for prevention.

Study Design. Review of a prospectively collected growing rod database. Objective. To define risk factors for and characterize the nature of growing rod fractures. Summary of Background Data. Rod fracture is a common complication of growing rod treatment. The project sought to analyze risk factors for rod breakage and develop preventive strategies. Methods. Records of 327 patients in a prospectively collected growing rod database were studied. Risk factors studied were studied as patient-related and rod-related. Multivariate analysis was performed. Results. Eighty-six rod fractures occurred in 49 patients (49 of 327, 15%). Sixteen patients had repeat fractures with eight patients having more than two fractures (maximum six). The most common fracture locations were above or below the tandem connectors (34 of 86) and near the thoracolumbar junction (35 of 86). Other locations were adjacent to anchors (12 of 86) and cross-links (2 of 86). Syndromic diagnoses had the highest rate of fracture; significantly greater than neuromuscular diagnoses (14% vs. 2%, P = 0.01). Patients who were ambulatory had a higher fracture rate (21% vs. 8.7%, P = 0.01). Single rods had a higher fracture rate than dual rods (36% vs. 11%, P < 0.001). Repeat fracture was also more common in patients with single rods (13% vs. 2%, P = 0.0002). In dual-rod constructs, the incidence of both rods breaking at the same time was 26% (7 of 27). Stainless steel rods had a higher fracture rate than titanium rods (29% vs. 18%, P = 0.02). The nonfracture group had larger diameter rods than the fracture group (P = 0.01). The fracture group had shorter tandem connectors than the nonfracture group (P < 0.001). Neither the size of preoperative scoliosis (P = 0.2) nor kyphosis (P = 0.4) was a risk factor for fracture. Length of instrumentation (P = 0.9), anchor type (P = 0.6), and pelvic fixation (P = 0.38) had no significant effect on fracture rates. Eight wound complications were reported, including three cases of skin breakdown at the rod fracture site. Conclusion. Risk factors for rod fractures include prior fracture, single rods, stainless steel rods, small diameter rods, proximity to tandem connectors, short tandem connectors, and preoperative ambulation. Repeat fractures are common, especially with single rods. Rod replacement, with larger diameter rods if appropriate, may be a preferred strategy over connecting the broken rods as fractures signal fatigue of the rod.

Submuscular Isola rod with or without limited apical fusion in the management of severe spinal deformities in young children: preliminary report.

Study Design. Retrospective review of the results of submuscular rod placement with and without limited apical fusion for the treatment of severe spinal deformities in young children. Objectives. To determine the success of this method for controlling severe deformities while allowing for spinal growth and to compare this method with previously reported results. Summary of Background Data. A variety of methods for controlling scoliosis in young children have been reported, but complications including spontaneous fusion, loss of correction, instrumentation failure, and limited spinal growth are common. Methods. The cases of 29 young children with progressive scoliosis or kyphoscoliosis as a result of a variety of diagnoses treated with a submuscular Isola rod and a postoperative orthosis were retrospectively reviewed. Eleven patients also had a short anterior and posterior apical fusion or convex hemiepiphysiodesis to aid in correction and stabilization of their deformity. The remaining 18 patients had a submuscular rod only. Results. The mean age at surgery was 6.7 years (range, 1–11 years). The initial preoperative mean magnitude of the major curve was 66° (range, 42–112°). After surgery this decreased to a mean of 38° (range, 16–70°). The most recent radiographs demonstrated a mean 47° curve (range, 28–79°). The mean number of lengthenings per patient has been two (range, 0–5). Nine patients have reached a suitable age and have been converted to a posterior spinal fusion and segmental spinal instrumentation. Nine complications have occurred in seven patients (24%). These included five hook displacements and three rod breakages. These were treated by hook reinsertion and rod exchange or sleeve and a repeat lengthening. There was one superficial infection treated medically. Conclusion. This technique is useful in the management of severe spinal deformities in young children who have either failed, or have a contraindication to, orthotic management. Complications are relatively frequent but well tolerated.

Compartment syndrome in ipsilateral humerus and forearm fractures in children

Ipsilateral fractures of the humerus and forearm are uncommon injuries in children. The incidence of compartment syndrome in association with these fractures is controversial. The authors reviewed 978 consecutive children admitted to the hospital with upper extremity long bone fractures during a 13-year period. Forty-three children with ipsilateral fractures of the humerus and forearm were identified. Of 33 children with a supracondylar humerus fracture and ipsilateral forearm fracture, three children (7%) had compartment syndrome develop and required forearm fasciotomies. All three cases of compartment syndrome occurred among nine children with ipsilateral displaced extension supracondylar humerus and displaced forearm fractures; the incidence of compartment syndrome was 33% in this group. These findings suggest that children who sustain a displaced extension supracondylar humerus fracture and displaced forearm fracture are at significant risk for compartment syndrome. These children should be monitored closely during the perioperative period for signs and symptoms of increasing intracompartmental pressures in the forearm.

A comparison of the thoracolumbosacral orthoses and providence orthosis in the treatment of adolescent idiopathic scoliosis: Results using the new SRS inclusion and assessment criteria for bracing studies

This is a retrospective cohort study comparing the effectiveness of the thoracolumbosacral orthosis (TLSO) and the Providence orthosis in the treatment of adolescent idiopathic scoliosis (AIS) using the new Scoliosis Research Society (SRS) Committee on Bracing and Nonoperative Management inclusion and assessment criteria for bracing studies. These new criteria will make future studies comparable and more valid and accurate. Methods We have used a custom TLSO (duration, 22 hours/day) and the Providence orthosis (duration, 8-10 hours/night) to control progressive AIS curves. Only 83 of 160 patients met the new SRS inclusion criteria: age of 10 years and older at initiation of bracing; initial curve of 25 to 40 degrees; Risser sign 0 to 2; female; premenarcheal or less than 1 year past menarche; and no previous treatment. There were 48 patients in the TLSO group and 35 in the Providence group. The new SRS assessment criteria of effectiveness included the percentage of patients who had 5 degrees or less and 6 degrees or more of curve progression at maturity, the percentage of patients whose curve progressed beyond 45 degrees, the percentage of patients who had surgery recommended or undertaken, and a minimum of 2 years of follow-up beyond maturity in those patients who were thought to have been successfully treated. All patients are evaluated regardless of compliance (intent to treat). Results There were no significant differences in age at brace initiation, initial primary curve magnitude, sex, or initial Risser sign between the 2 groups. In the TLSO group, only 7 patients (15%) did not progress (≤5 degrees), whereas 41 patients (85%) progressed by 6 degrees or more, including the 30 patients whose curves exceeded 45 degrees. Thirty-eight patients (79%) required surgery. In the Providence group, 11 patients (31%) did not progress, whereas 24 patients (69%) progressed by 6 degrees or more, including 15 patients whose curves exceeded 45 degrees. Twenty-one patients (60%) required surgery. However, when the initial curve at initiation of bracing was 25 to 35 degrees, the results improved. Five (15%) of 34 patients in the TLSO group and 10 (42%) of 24 patients in the Providence group did not progress, whereas 29 patients (85%) and 14 patients (58%), respectively, progressed by 6 degrees or more, and 26 patients (76%) and 11 patients (46%), respectively, required surgery. Conclusions Using the new SRS bracing criteria, the Providence orthosis was more effective for avoiding surgery and preventing curve progression when the primary initial curves at bracing was 35 degrees or less. However, the overall success of orthotic management for AIS in both groups was inferior to previous studies. Our results raise the question of the effectiveness of orthotic management in AIS and support the need for a multicenter, randomized study using these new criteria.