Benjamin D. Roye

Patient-based outcomes after clubfoot surgery.

Despite decades of experience in the area of clubfoot repair, considerable uncertainty remains regarding indications, surgical technique, and long-term results of treatment. Much of this uncertainty is due to the lack of a standardized and valid method for assessing postoperative outcomes of clubfoot repair. The current study used various end points to compare traditional and patient-based outcome measures and to develop a disease-specific instrument that is both meaningful to the patient and statistically valid. A cohort of 46 patients was identified, and several types of outcomes data were collected, including traditional end points of outcome (range of motion and radiographic criteria, qualitative patient-based data) and a previously validated instrument measuring pediatric functional status (FSIIr). At an average follow-up of 45 months, radiographic measures and range of motion were comparable to values published in previous studies. Postoperative functional status, as measured by the FSIIr, did not differ from that of age-matched controls. Psychometric analysis of these data allowed us to generate a 10-item disease-specific instrument (DSI), which conveyed patient-based attitudes toward outcome.

Idiopathic congenital talipes equinovarus.

The etiology of idiopathic congenital talipes equinovarus is unknown, and there is no consensus as to the best treatment. Increasingly, ultrasound is being used to diagnose the condition prenatally, but the diagnosis remains clinical postnatally. Radiographs can help confirm the diagnosis and ascertain the severity of the condition. There are many classification schemes, but none offers adequate prognostic value. The mainstay of treatment is manipulation and casting, usually followed by soft-tissue release. However, some patients have been successfully treated with intensive physiotherapy instead of surgery.

Psychosocial effects of repetitive surgeries in children with early-onset scoliosis: are we putting them at risk?

Background: The use of growing instrumentation in children with early-onset scoliosis (EOS) has created interest in determining if these repetitive procedures are prompting the development of lasting psychosocial problems. Given the increasing role of this treatment modality in the management of EOS, this study aimed to assess the psychological status of this patient population and to determine factors associated with worse scores in various psychosocial domains. Methods: A cross-sectional assessment of 34 EOS patients was performed utilizing 2 well-established, caregiver-completed psychiatric instruments: the Child Behavior Checklist (CBCL) and the Strength and Difficulties Questionnaire. Scores were calculated for 15 CBCL and 6 Strength and Difficulties Questionnaire domains and subdomains and grouped as “Normal” or “Abnormal” according to published normative values. The prevalence of abnormal scores was within each instrument subdomain and was compared with the national norms. Domain scores were also correlated with age at first scoliosis surgery, total number of operative procedures, and total number of growing instrumentation surgeries. Results: A higher prevalence of Abnormal scores were found in multiple psychosocial domains in our cohort as compared with national normative data. Children with Abnormal CBCL “Total Problems” domain scores were younger at the time of first scoliosis surgery (2.50 vs. 5.52 y). Normal and Abnormal scoring groups showed significant differences in the number of (1) total surgeries; (2) total scoliosis surgeries; and (3) growing instrumentation surgeries in multiple domains on both instruments. Aggression, Rule-breaking, and Conduct were positively correlated with total number of surgeries. Conclusions: Our findings showed a higher prevalence of Abnormal psychosocial scores in multiple domains in multioperated EOS patients as compared with national norms. Our findings suggest that EOS patients with abnormal psychosocial scores were younger at the time of their initial scoliosis surgery. The number of repetitive surgeries also correlated positively with 3 behavioral problem scores. Although healthier scores were seen in 1 positive behavioral domain in more operated children suggesting the potential for “posttraumatic growth,” the other findings of this study are concerning given the increasing use of this treatment modality and indicate a need for ongoing screening and mental health care in this high-risk population. Level of Evidence: Level III—case-control.

Does ScoliScore provide more information than traditional clinical estimates of curve progression

Study Design. Retrospective study comparing ScoliScore and clinical risk estimates. Objective. The purpose of this study was to compare risk stratification between ScoliScore and traditional clinical estimates to determine whether ScoliScore provides unique information. Summary of Background Data. ScoliScore is a genetic prognostic test designed to evaluate the risk of curve progression in skeletally immature patients with adolescent idiopathic scoliosis with Cobb angles of 10° to 25°. Clinicians are currently trying to better understand the role this test may play in guiding clinical decision making because current standards of curve progression are largely based on radiographical markers, such as curve magnitude and bone age. Methods. Ninety-one patients who received ScoliScore testing at our center and met study inclusion criteria were identified. Patients were given a “clinical risk” level using their Risser sign and Cobb angle. Assigned clinical risk levels were compared with the ScoliScore risk levels reported by the manufacturers scoring algorithm. Results. ScoliScore risk distribution in our population was 36% low risk, 55% intermediate risk, and 9% high risk. This compares with 2%, 51%, and 47%, respectively, for comparable clinical risk groupings. Only 25% of patients were in the same risk category for both systems. There were no significant correlations between ScoliScore and age, race, menarcheal status, Risser sign, or sex. There was a positive correlation between the Cobb angle and the ScoliScore (r = 0.581, P < 0.001). Cobb angle remained significant in the multivariate regression model (P < 0.001), and Cobb angle was found to account for 33.3% of ScoliScores variance. Conclusion. Only Cobb angle showed significant correlation with ScoliScore among the socioclinical variables studied. The risk distribution of the 2 risk estimation systems examined differed markedly: ScoliScore predicted nearly 16 times more low-risk patients and more than 5 times fewer high-risk patients. This demonstrates that ScoliScore provides unique information to traditional predictors of curve progression, advancing our understanding of the role of ScoliScore in the clinical setting.

Reduction in upper-extremity tone after lumbar selective dorsal rhizotomy in children with spastic cerebral palsy

OBJECT Randomized clinical trials have established that lumbar selective dorsal rhizotomy (SDR) reduces lower-extremity tone and improves functional outcome in children with spastic cerebral palsy. Significant data exist to support a secondary effect on upper-extremity function in patients with upper-extremity spasticity. The effects of SDR on upper-extremity tone, however, are not well characterized. In this report, the authors sought to assess changes in upper-extremity tone in individual muscle groups after SDR and tried to determine if these changes could be predicted preoperatively. METHODS The authors retrospectively reviewed 42 children who underwent SDR at Columbia University Medical Center/Morgan Stanley Childrens Hospital of NewYork-Presbyterian between 2005 and 2011. Twenty-five had upper-extremity spasticity. All underwent pre- and postoperative examination for measuring tone (Modified Ashworth Scale) and assessing functional outcome. Follow-up examinations with therapists were performed at least once at a minimum of 2 months postoperatively (mean 15 months). RESULTS In the upper extremities, 23 (92%) of 25 patients had improvements of at least 1 Ashworth point in 2 or more independent motor groups on the Modified Ashworth Scale, and 12 (71%) of 17 families surveyed reported increases in motor control or spontaneous movement. The mean Modified Ashworth Scale scores for all upper-extremity muscle groups demonstrated an improvement from 1.34 to 1.22 (p < 0.001). Patients with a mean preoperative upper-extremity tone of 1.25-1.75 were most likely to benefit from reduction in tone (p = 0.0019). Proximal and pronator muscle groups were most likely to demonstrate reduced tone. CONCLUSIONS In addition to improvements in lower-extremity tone and function, SDR has demonstrable effects on upper extremities. Greater than 90% of our patients with elevated upper-extremity tone demonstrated reduction in tone in at least 2 muscle groups postoperatively. Patients with a mean Modified Ashworth Scale upper-extremity score of 1.25-1.75 may encounter the greatest reduction in upper-extremity tone.

An Independent Evaluation of the Validity of a DNA-Based Prognostic Test for Adolescent Idiopathic Scoliosis.

BACKGROUND ScoliScore is a DNA-based prognostic test, designed and used to help to predict the risk of curve progression in patients with adolescent idiopathic scoliosis. The role of this test in clinical practice remains unclear as the published results of the ScoliScore have not been validated independently. The purpose of this study was to determine if the ScoliScore effectively predicted the risk of curve progression in patients with mild and moderate adolescent idiopathic scoliosis in two urban academic medical centers. METHODS One hundred and twenty-six patients with adolescent idiopathic scoliosis who met inclusion criteria at two centers were administered the ScoliScore test. Two groups were created: a progression group (those who had a Cobb angle of >40° or those who had undergone surgical fusion) and a non-progression group (those who had skeletal maturity without curve progression to 40°). ScoliScore values and risk levels were compared between the two groups. The negative predictive value was calculated for low-risk scores and the positive predictive value was calculated for high-risk scores. RESULTS There was no significant difference (p = 0.706) in the mean ScoliScore (and standard deviation) between patients with curve progression (107 ± 55 points) and those without curve progression (102 ± 62 points). There was also no significant difference (p = 0.399) in curve progression between patients with high-risk scores (26.7%) and those with low-risk scores (12.9%). The positive predictive value of the test was 0.27 (95% confidence interval, 0.09 to 0.55), and the negative predictive value was 0.87 (95% confidence interval, 0.69 to 0.96). ScoliScores and rates of progression were not affected by brace-wear. CONCLUSIONS ScoliScores did not differ between patients with and without curve progression, and the negative and positive predictive values were lower in our study than in the previously published validation study by the developers of the test. This may be due to differences in our test population, genetic variability, or failure of patients in the non-progression group to follow up.

Selection of appropriate outcomes instruments.

Patient based outcomes research continues to grow and expand, as evidenced by recent missions by the federal government and private organizations to fund this area of study. As orthopaedic surgeons, we can improve our ability to provide the highest level of care for our patients beyond the skills and tools available to us in the operating room. Understanding the advantages and disadvantages of using various patient based outcome measures can be a daunting task and could deter many orthopaedic surgeons from applying these useful tools to their practice. This article aims to summarize the importance and proper usage of the many outcomes instruments available to orthopedic surgeons.

Agreement Between Manual and Computerized Designation of Neutral Vertebra in Idiopathic Scoliosis

STUDY DESIGN Survey-based cross-sectional study. OBJECTIVES To describe interobserver agreement among experienced spine surgeons in choosing neutral vertebra (NV) based on manual measurements from radiographs. Secondarily, to use axial vertebral rotation (AVR) values obtained from low-dose stereoradiography (SR) post-processing software (SterEOS 2D/3D) to separately designate the NV in subject cases and to compare manually derived and software-derived NV designations. SUMMARY OF BACKGROUND DATA Investigators have previously suggested that parameters such as Lenke classification, stable vertebra level, end vertebra level, and NV level be used to decide on fusion levels in adolescent idiopathic scoliosis (AIS). Studies have revealed suboptimal interobserver reliability in these vertebral designations. SR post-processing software may represent a useful tool for standardizing NV designation. METHODS Thirty-two subjects with idiopathic scoliosis and Lenke 1-4 curves were assessed. Experienced surgeons (range of 7-35 years in practice) assigned NV based on preoperative radiographs. Interobserver reliability was quantified using the Fleiss Kappa statistic. Surgeon responses were compared with NV designations made using AVR values provided by SR postprocessing software. Agreement between these values was quantified using percentage agreement. RESULTS Surgeons exhibited moderate agreement in choosing NV based on radiographs (Kappa 0.444). Surgeon responses agreed with the SR-derived NV in 26.9% of cases, lay within 1 level in 82.1% of cases, and lay within 2 levels in 97.5% of cases. Surgeons were more likely to choose distal to the SR NV rather than proximal. CONCLUSIONS Variability in instrumented level selection and outcomes in idiopathic scoliosis may be partially related to inconsistency in selection of the NV. The use of SR post-processing software may provide a more reliable method for choosing NV. LEVEL OF EVIDENCE Level II.STUDY DESIGN Survey-based cross-sectional study. OBJECTIVES To describe interobserver agreement among experienced spine surgeons in choosing neutral vertebra (NV) based on manual measurements from radiographs. Secondarily, to use axial vertebral rotation (AVR) values obtained from low-dose stereoradiography (SR) post-processing software (SterEOS 2D/3D) to separately designate the NV in subject cases and to compare manually derived and software-derived NV designations. Investigators have previously suggested that parameters such as Lenke classification, stable vertebra level, end vertebra level, and NV level be used to decide on fusion levels in adolescent idiopathic scoliosis (AIS). Studies have revealed suboptimal interobserver reliability in these vertebral designations. SR post-processing software may represent a useful tool for standardizing NV designation. METHODS Thirty-two subjects with idiopathic scoliosis and Lenke 1-4 curves were assessed. Experienced surgeons (range of 7-35 years in practice) assigned NV based on preoperative radiographs. Interobserver reliability was quantified using the Fleiss Kappa statistic. Surgeon responses were compared with NV designations made using AVR values provided by SR postprocessing software. Agreement between these values was quantified using percentage agreement. RESULTS Surgeons exhibited moderate agreement in choosing NV based on radiographs (Kappa 0.444). Surgeon responses agreed with the SR-derived NV in 26.9% of cases, lay within 1 level in 82.1% of cases, and lay within 2 levels in 97.5% of cases. Surgeons were more likely to choose distal to the SR NV rather than proximal. CONCLUSIONS Variability in instrumented level selection and outcomes in idiopathic scoliosis may be partially related to inconsistency in selection of the NV. The use of SR post-processing software may provide a more reliable method for choosing NV. LEVEL OF EVIDENCE Level II.

Expert Consensus and Equipoise: Planning a Randomized Controlled Trial of Magnetically Controlled Growing Rods

STUDY DESIGN Expert consensus building using combined Delphi method and Nominal group technique. OBJECTIVES To identify the current state of equipoise surrounding the use of magnetically controlled growing rods (MCGRs) and to determine consensus for planning a randomized controlled trial (RCT) with MCGRs. BACKGROUND The use of MCGRs for the treatment of early-onset scoliosis (EOS) is a new technology. Optimal use has not been thoroughly investigated and much uncertainty exists. Areas of uncertainty include construct architecture, timing of lengthenings, and amount of distraction per lengthening. Expert discussion and consensus is useful at this early juncture and necessary when designing an RCT. METHODS Two rounds of surveys were administered to a group of experienced pediatric spine surgeons, followed by a 2-hour, face-to-face meeting in November 2015 and a 1-hour, face-to-face meeting in February 2016. The first survey used example cases to establish agreement around the proper use of MCGRs and identified areas of equipoise and disagreement. The second survey again used example cases-this time selected for their equipoise status-to solicit trial arms for a potential RCT of MCGRs and identified important open questions in the use of MCGRs. Lastly, the face-to-face meetings employed iterative voting to preliminarily plan an RCT of MCGRs. RESULTS Following the Delphi survey rounds and the two Nominal face-to-face meetings, the group of experts decided on an MCGR RCT design that standardized all patients to bidirectional constructs, and randomized to a lengthening interval of 6 versus 16 weeks with a standardized equation for calculating the total yearly lengthening that approximates normal spine growth. CONCLUSION This endeavor indicates expert support for the use of MCGR in children older than 6 years, with curves greater than 60°. The uncertainty surrounding frequency of lengthening justifies an RCT of MCGRs. LEVEL OF EVIDENCE Level V.STUDY DESIGN Expert consensus building using combined Delphi method and Nominal group technique. OBJECTIVES To identify the current state of equipoise surrounding the use of magnetically controlled growing rods (MCGRs) and to determine consensus for planning a randomized controlled trial (RCT) with MCGRs. BACKGROUND The use of MCGRs for the treatment of early-onset scoliosis (EOS) is a new technology. Optimal use has not been thoroughly investigated and much uncertainty exists. Areas of uncertainty include construct architecture, timing of lengthenings, and amount of distraction per lengthening. Expert discussion and consensus is useful at this early juncture and necessary when designing an RCT. METHODS Two rounds of surveys were administered to a group of experienced pediatric spine surgeons, followed by a 2-hour, face-to-face meeting in November 2015 and a 1-hour, face-to-face meeting in February 2016. The first survey used example cases to establish agreement around the proper use of MCGRs and identified areas of equipoise and disagreement. The second survey again used example cases-this time selected for their equipoise status-to solicit trial arms for a potential RCT of MCGRs and identified important open questions in the use of MCGRs. Lastly, the face-to-face meetings employed iterative voting to preliminarily plan an RCT of MCGRs. RESULTS Following the Delphi survey rounds and the two Nominal face-to-face meetings, the group of experts decided on an MCGR RCT design that standardized all patients to bidirectional constructs, and randomized to a lengthening interval of 6 versus 16 weeks with a standardized equation for calculating the total yearly lengthening that approximates normal spine growth. CONCLUSION This endeavor indicates expert support for the use of MCGR in children older than 6 years, with curves greater than 60°. The uncertainty surrounding frequency of lengthening justifies an RCT of MCGRs. LEVEL OF EVIDENCE Level V.

Comparison of Complications and unplanned OR visits between Magnetically Controlled Growing Rods and Vertical Expandable Prosthetic Titanium Rib

Patients undergoing primary insertion of magnetically controlled growing rod (MCGR) compared to Vertical Expandable Prosthetic Titanium Rib (VEPTR) have higher overall complication and implant-related complications per procedure despite similar complication risk per patient. While there was a reduction in total repetitive surgeries in patients with MCGR implants, there was no significant difference in mean unplanned OR visits per patient between the groups.