2011 SOSORT guidelines: Orthopaedic and Rehabilitation treatment of idiopathic scoliosis during growth.

BACKGROUND: The International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT), that produced its first Guidelines in 2005, felt the need to revise them and increase their scientific quality. The aim is to offer to all professionals and their patients an evidence-based updated review of the actual evidence on conservative treatment of idiopathic scoliosis (CTIS). METHODS: All types of professionals (specialty physicians, and allied health professionals) engaged in CTIS have been involved together with a methodologist and a patient representative. A review of all the relevant literature and of the existing Guidelines have been performed. Documents, recommendations, and practical approach flow charts have been developed according to a Delphi procedure. A methodological and practical review has been made, and a final Consensus Session was held during the 2011 Barcelona SOSORT Meeting. RESULTS: The contents of the document are: methodology; generalities on idiopathic scoliosis; approach to CTIS in different patients, with practical flow-charts; literature review and recommendations on assessment, bracing, physiotherapy, Physiotherapeutic Specific Exercises (PSE) and other CTIS. Sixty-five recommendations have been given, divided in the following topics: Bracing (20 recommendations), PSE to prevent scoliosis progression during growth (8), PSE during brace treatment and surgical therapy (5), Other conservative treatments (3), Respiratory function and exercises (3), Sports activities (6), Assessment (20). No recommendations reached a Strength of Evidence level I; 2 were level II; 7 level III; and 20 level IV; through the Consensus procedure 26 reached level V and 10 level VI. The Strength of Recommendations was Grade A for 13, B for 49 and C for 3; none had grade D. CONCLUSION: These Guidelines have been a big effort of SOSORT to paint the actual situation of CTIS, starting from the evidence, and filling all the gray areas using a scientific method. According to results, it is possible to understand the lack of research in general on CTIS. SOSORT invites researchers to join, and clinicians to develop good research strategies to allow in the future to support or refute these recommendations according to new and stronger evidence.

SpineCor treatment for Juvenile Idiopathic Scoliosis: SOSORT award 2010 winner.

INTRODUCTION: Juvenile idiopathic scoliosis is a condition used to describe patients who are least 4 years of age but younger than 10 when the deformity is first identified. In these patients, the condition is usually progressive and those that are diagnosed at five years or younger have a high chance of progression to a large curve, with additional pulmonary and cardiac complications. The main form of conservative treatment for juvenile scoliosis is the use of a bracing system. This prospective interventional study was conducted to evaluate the effectiveness of the Dynamic SpineCor orthosis for juvenile idiopathic scoliosis as well as to evaluate the stability of the spine after the weaning point. MATERIAL AND METHODS: For this study, 150 juvenile patients were treated by the SpineCor orthosis between 1993 and 2009. Of these, 67 patients had a definite outcome and 83 are still actively being treated. To determine the effectiveness of the brace the OUTCOME criteria recommended by the SRS was used. RESULTS: The results from our study showed that of the 67 patients with a definite outcome, 32.9% corrected their Cobb angle by at least 5° and 10.5% had a stabilization of their Cobb angle. Within the patients with a definite outcome, 37.3% of patients where recommended for surgery before authorized end of treatment. For this group of patients, surgery was postponed. Looking at the stability of the curves 2 years after the end of the treatment, we found 12.5% of the patients continued their correction without the brace being used and 71.4% remained stable. DISCUSSION: From our study we can clearly see that the effectiveness of the SpineCor orthosis in obtaining and maintaining the neuromuscular integration of the corrective movement can be achieved effectively for juvenile patients. Over 75% of all patients that finished the treatment had remained stable with a few continuing to correct their Cobb angle after the use of the SpineCor orthosis was discontinued. CONCLUSION: Our conclusion from this study is that the SpineCor orthosis is a very effective method of treatment of juvenile idiopathic scoliosis. The results obtained also indicate that treatment outcomes are better with early bracing. Most encouraging perhaps is the fact that the positive outcome appears to be maintained in the long term, and that surgery can be avoided or at least postponed.

Postural imbalance in non-treated adolescent idiopathic scoliosis at different periods of progression.

The aim of this study was to test the hypothesis that imbalance in patients with a severe deformity of the spine is associated with an increase in the sensory integration disorder. This paper is a case comparison study. Patients were divided into three groups: able-bodied (n = 53), observation (n = 23), and pre-brace (n = 26) groups. Time domain parameters (sway area, position and displacement) and structural posturographic parameters [mean distance (MD) and mean peak (MP)] were calculated from the COP excursion using a force platform. A sensory integration disorder could be an important factor in the progression of the scoliotic curve. Significant differences were found in time domain between observation, pre-brace and able-bodied groups. The results for the structural posturographic parameters showed significant differences between the pre-brace and the able-bodied groups (P = 0.018 MD and P = 0.02 MP) demonstrating a perturbation in sensory integration system by an increase of imbalance. The absence of statistical difference between the observation and the pre-brace groups for the structural posturographic parameters indicates a perturbation of sensory integration system associated with curve progression. Our study has demonstrated that the pre-brace group is less stable than the able-bodied group. The severity of scoliosis in pre-brace scoliotic girls could be related to an increase in the sensory integration disorder.

A new concept for the non-invasive treatment of Adolescent Idiopathic Scoliosis: the Corrective Movement principle integrated in the SpineCor System.

PURPOSE: To evaluate the change in spinal curvature and posture of Idiopathic Scoliosis patients when a curve specific 'Corrective Movement Principle' (CMP) is applied. METHODS: This prospective interventional study was carried out on a group of 639 patients (92.3% females) having idiopathic scoliosis treated with the SpineCor brace. All girls were premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness followed the SRS outcome criteria for bracing. The clinical, radiological and postural evaluations assisted to define the patient classification, which guided the unique application of the CMP to each type of curvature. RESULTS: A total of 583 patients met the outcome criteria. Overall, 349 patients have a definitive outcome. Successful treatment was achieved in 259 (74.2%) of the 349 patients from the fitting to the weaning of the brace. Some 51 immature patients (14.6%) required surgical fusion while receiving treatment. Eight mature patients out of 298 (2.7%) required surgery within 2 years of follow-up beyond skeletal maturity. CONCLUSION: The SpineCor brace is effective for the treatment of adolescent idiopathic scoliosis. Moreover, positive outcomes are maintained after 2 years because 151 (93.2%) of 162 patients stabilized or corrected their end of bracing Cobb angle up to 2 years after bracing.

Postural characteristics of adolescents with idiopathic scoliosis.

BACKGROUND: The objectives of this study were to compare the postural characteristics of idiopathic scoliosis (IS) patients with different types of spinal curvature and to compare a motion capture and a sequential digitization technique to estimate the postural characteristics of the IS patients. METHODS: A total of 57 IS patients underwent a radiological, clinical, and postural geometric evaluations in an upright standing position as part of their regular follow-up. The posteroanterior radiograph of the trunk was used to measure the amplitude of spinal curvature. The postural evaluation was performed using a motion capture and sequential digitization technique providing the necessary 3-dimensional positions of anatomical landmarks. These landmarks were used to calculate postural parameters defining the position and orientation of the pelvis, shoulders, and shoulder blades. These measurements included lateral shift and angular measures of rotation and tilt. RESULTS: Significant differences in the frontal and transverse planes were found between the right thoracic (RTh), left thoracolumbar, and RTh-left lumbar (RThLL) patients. These characteristics were most prominent in the transverse plane for RTh patients, in the frontal plane for left thoracolumbar patients, and in the frontal and transverse planes for the RThLL lumbar patients. A strong positive intraclass correlation was also found between the parameters estimated with the motion capture system and with the sequential digitization system. CONCLUSIONS: Unique postural characteristics that are related to the type of the spinal curvature are evident in adolescents who have IS. Further work is necessary to assess how these measures may be used to monitor the progression of the spinal deformity. CLINICAL RELEVANCE: Quantifying the postural alignment of IS patients using surface anthropometric landmarks provides an opportunity to characterize the unique postural attributes that accompany each type of spinal curvature.

Treatment of early adolescent idiopathic scoliosis using the SpineCor System.

The purpose of this prospective observational study was to evaluate the effectiveness of the Dynamic SpineCor System for adolescent idiopathic scoliosis in accordance with the standardized outcome criteria proposed by the Scoliosis Research Society Committee on Bracing and Nonoperative Management. The SpineCor System is the first and only truly dynamic brace, which provides a progressive correction of Idiopathic Scoliosis from 15 degrees Cobb angle and above. The new therapeutic approach is based on a new concept upon the etiology and pathogenesis of idiopathic scoliosis; a pathology of the neuro-musculoskeletal system in growth and maturation. This prospective observational study was carried out on a group of 639 patients (92.3% females) having idiopathic scoliosis treated with the SpineCor brace. Five hundred and eighty three patients met the criteria for inclusion, and 234 patients were still actively being treated. Overall, 349 patients have a definitive outcome. All girls were premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness included (1) percentage of patients who have 5 degrees or less curve progression, and percentage of patients who have 6 degrees or more progression; (2) percentage of patients who have been recommended/undergone surgery before skeletal maturity; (3) percentage of patients with curves exceeding 45 degrees at maturity (end of treatment); and (4) Two-year follow-up beyond maturity to determine the percentage of patients who subsequently underwent surgery. Successful treatment (correction, > 5 degrees, or stabilization, +/- 5 degrees) was achieved in 259 (74.2%) of the 349 patients from the time of the fitting of the SpineCor brace to the point in which it was discontinued (or at the time of the surgery). Fifty one immature patients (14.6%) required surgical fusion while receiving treatment. Eight mature patients out of 298 (2.7%) required surgery within 2 years of follow-up beyond skeletal maturity. The conclusion drawn from these findings is that the SpineCor brace is effective for the treatment of adolescent idiopathic scoliosis. Moreover, positive outcomes are maintained after 2 years because 151 (93.2%) of 162 patients stabilized or corrected their end of bracing Cobb angle up to 2 years after bracing.

Estimation of the centre of mass for the study of postural control in Idiopathic Scoliosis patients: a comparison of two techniques.

The objective of the present study is to quantify the position of the Centre of Mass (COM) during quiet standing using a force plate and compare this technique to the quantification of the COM with an anthropometric model. The postural control of 18 healthy adolescents and 22 IS patients was evaluated using an Optotrak 3D kinematic system, and two AMTI force plates during quiet standing. The position of anatomical landmarks tracked by the Optotrak system served to estimate the position of the COM of both groups using an anthropometric model (COM(anth)). The force plate served to estimate the position of the COM through double integration of the horizontal ground reaction forces (COM(gl)). The mean position and root mean square (RMS) amplitude of COM(gl, )in reference to the base of support (BOS) and the first sacral prominence (S1) were quantified in the Anterior-Posterior (A/P) and Medial-Lateral (M/L) directions. There was a significant difference between the control subjects and IS patients for the displacement of the COM(gl) in reference to the BOS in both the A/P and M/L directions. There was no difference between groups for the mean position of the COM(gl), however, 63% of the IS and 43% of the controls had a lateral position of the COM(gl )in reference to S1 of greater than 5 mm. There was a significant difference between groups in the A/P and M/L directions for the amplitude of error between the COM(gl) and COM(anth) techniques.

Effectiveness of the SpineCor brace based on the new standardized criteria proposed by the scoliosis research society for adolescent idiopathic scoliosis.

The purpose of this prospective observational study was to evaluate the effectiveness of the Dynamic SpineCor brace for adolescent idiopathic scoliosis in accordance with the standardized criteria proposed by the Scoliosis Research Society Committee on Bracing and Nonoperative Management. They proposed these guidelines to make the comparison among studies more valid and reliable. From 1993 to 2006, 493 patients were treated using the SpineCor brace. Two hundred forty-nine patients met the criteria for inclusion, and 79 patients were still actively being treated. Overall, 170 patients have a definitive outcome. All girls were premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness included (1) percentage of patients who have 5 degrees or less curve progression, and percentage of patients who have 6 degrees or more progression; (2) percentage of patients who have been recommended/undergone surgery before skeletal maturity; (3) percentage of patients with curves exceeding 45 degrees at maturity (end of treatment); and (4) Two-year follow-up beyond maturity to determine the percentage of patients who subsequently underwent surgery. Successful treatment (correction, >5 degrees, or stabilization, +/-5 degrees) was achieved in 101 (59.4%) of the 170 patients from the time of the fitting of the SpineCor brace to the point in which it was discontinued. Thirty-nine immature patients (22.9%) required surgical fusion while receiving treatment. Two (1.2%) of 170 patients had curves exceeding 45 degrees at maturity. One mature patient (2.1%) required surgery within 2 years of follow-up beyond skeletal maturity. The conclusion drawn from these findings is that the SpineCor brace is effective for the treatment of adolescent idiopathic scoliosis. Moreover, positive outcomes are maintained after 2 years because 45 (95.7%) of 47 patients stabilized or corrected their end of bracing Cobb angle up to 2 years after bracing. Therapeutic study-investigating the results of treatment: level II.

The spinal cord dura mater reaction to nitinol and titanium alloy particles: a 1-year study in rabbits.

This investigation was undertaken to simulate in an animal model the particles released from a porous nitinol interbody fusion device and to evaluate its consequences on the dura mater, spinal cord and nerve roots, lymph nodes (abdominal para-aortic), and organs (kidneys, spleen, pancreas, liver, and lungs). Our objective was to evaluate the compatibility of the nitinol particles with the dura mater in comparison with titanium alloy. In spite of the great use of metallic devices in spine surgery, the proximity of the spinal cord to the devices raised concerns about the effect of the metal debris that might be released onto the neural tissue. Forty-five New Zealand white female rabbits were divided into three groups: nitinol (treated: N = 4 per implantation period), titanium (treated: N = 4 per implantation period), and sham rabbits (control: N = 1 per observation period). The nitinol and titanium alloy particles were implanted in the spinal canal on the dura mater at the lumbar level L2-L3. The rabbits were sacrificed at 1, 4, 12, 26, and 52 weeks. Histologic sections from the regional lymph nodes, organs, from remote and implantation sites, were analyzed for any abnormalities and inflammation. Regardless of the implantation time, both nitinol and titanium particles remained at the implantation site and clung to the spinal cord lining soft tissue of the dura mater. The inflammation was limited to the epidural space around the particles and then reduced from acute to mild chronic during the follow-up. The dura mater, sub-dural space, nerve roots, and the spinal cord were free of reaction. No particles or abnormalities were found either in the lymph nodes or in the organs. In contact with the dura, the nitinol elicits an inflammatory response similar to that of titanium. The tolerance of nitinol by a sensitive tissue such as the dura mater during the span of 1 year of implantation demonstrated the safety of nitinol and its potential use as an intervertebral fusion device.

Evaluation of segmental postural characteristics during quiet standing in control and Idiopathic Scoliosis patients.

BACKGROUND: The complex skeletal deformations that accompany Idioapthic Scoliosis pose a challenge to the clinician to non-invasively discriminate Idiopathic Scoliosis patients from children with no pathology. Therefore, the focus of this study is to non-invasively evaluate the position and amplitude of displacement of the pelvis, shoulders and thorax during quiet standing of Idiopathic Scoliosis patients and control subjects. METHODS: The quiet standing posture of 18 healthy adolescent females and 22 Idiopathic Scoliosis subjects was evaluated using an Optotrak 3020 position sensor over a period of 120 s, with 4 repeat trials. Outcome measures included the mean position, root mean square amplitude and range over the duration of 120 s trials for both linear and angular measures of the pelvis, thorax and shoulders. Appropriate sample times were chosen and evaluated for stability over the 120 s period, and between trial reliability was evaluated. FINDINGS: There was a significant difference between groups for the mean position of the shoulder blade rotation in reference to the base of support and to the pelvis. The Idiopathic Scoliosis patients had a significantly larger root mean square amplitude of anterior-posterior displacement of the T1 and S1 spinous processes in reference to the base of support. There was no difference between the sample durations to estimate the mean position of the body segments, however the root mean square increased significantly. INTERPRETATION: This study demonstrates that postural abnormalities are evident during quiet standing in Idiopathic Scoliosis patients.

Porous titanium-nickel for intervertebral fusion in a sheep model: part 1. Histomorphometric and radiological analysis.

Porous titanium-nickel (PTN) implants represent an alternative to traditional intervertebral fusion cages. Indeed, PTN materials possess interconnecting pores with cell capillarity properties that may promote bone ingrowth and intervertebral fusion without the need for bone grafting. In this study, a PTN intervertebral fusion device was compared to a conventional TiAlV cage packed with autologous bone in a sheep model. The two devices were implanted at two noncontiguous intervertebral lumbar sites for 3, 6, and 12 months. PTN osseointegration showed a time-dependent trend increasing from 21.4% to 37.6% (3-12 months), whereas TiAlV cages remained at the same level of bone ingrowth (22.7%-25.4%; 3-12 months). Furthermore, PTN bone apposition (10.9%-24.2%; 3-12 months) was significantly higher than that of TiAlV implants (1.1%-5.1%; 3-12 months; p < 0.001, ANOVA). Radiological fusion scores increased with postsurgery time regardless of material type, but were consistently superior for PTN (12.5-18.5; 3-12 months) than for TiAlV cages (2.0-15.0; 3-12 months; p < 0.001, ANOVA). Implant materials were not significantly different according to the radiological interbody index based on preoperative disc height: Interbody index began at 132.6% (PTN) and 123.5% (TiAlV) immediately after surgery, then declined to 80.8% (PTN) and 91.0% (TiAlV) after 12 months. Nevertheless, ungrafted PTN constituted an excellent substrate for osteogenic cell integration and represents a new osteoconductive biomaterial with improved fusion characteristics in comparison to conventional TiAlV cages.

A new porous titanium-nickel alloy: Part 1. Cytotoxicity and genotoxicity evaluation.

Porous titanium-nickel (PTN) alloys represent new biomaterials for long-term implantation. Their porosity properties might confer them the capacity to trigger fluid capillarity, tissue ingrowth, as well as good tissue-implant apposition and fixation. Before PTN materials are used as long-term implants, their biocompatibility level must be assessed. In this study, porous titanium-nickel was therefore extracted in a saline semi-physiological solution and materials were evaluated for potential cytotoxicity and genotoxicity reactions. The cytocompatibility elution test was performed in order to determine PTN toxic potential at the in vitro cellular level: no reactivity was detected in cell layers exposed to PTN extracts or the negative controls. In parallel, the genocompatibility of porous titanium-nickel was evaluated using three different assays in order to assess potential damage at the DNA level: the test for chemical induction of chromosome aberrations, the Salmonella typhimurium and Escherichia coli reverse mutation assay, and the mouse micronucleus test. No significant increase in the number of chromosomal aberrations, bacterian revertant colonies, or micronuclei was observed in presence of PTN extracts when compared to negative control exposition. Based on the above results, porous titanium-nickel can be considered completely cytocompatible and genocompatible, and therefore represents a good candidate for long-term implantation.

In vivo biocompatibility testing of peek polymer for a spinal implant system: a study in rabbits.

We are developing a new spinal implant system (SIS) without fusion (bone graft). This SIS is made from two materials, metal and polyetheretherketone (PEEK) polymer. The Food and Drug Administration recommended testing in vivo, in an animal model, whether the PEEK polymer could be used in a SIS without any harm of wear debris to the nervous tissue (spinal cord and nerve roots). The objective was to evaluate the biological response of the spinal cord and nerve roots (dura mater) to PEEK polymer particles. Twenty-four female New Zealand white rabbits were used. The rabbits were divided into three groups: test (n = 12), control (n = 9), and sham (n = 3). During the surgery, the test group received the PEEK particle injections (5 x 10(7) particles per site, lumbar and thoracic), while the control group received only the vehicle (0.9% saline solution). The sham group had the same surgical approach without injection. In each group, the rabbits were euthanized at 1, 4, and 12 weeks postsurgery. The macroscopic and semiquantitative histologic analyses of the spinal cords (dura mater) showed normal vascularization and particle adherence to the connective tissue especially at the injection sites. Neither necrosis nor swelling of the dura mater and nerve roots was observed. The PEEK polymer is harmless to the spinal cord; thus it might be used as component in the spinal implant system.

Estimated kyphosis and lordosis changes at follow-up in patients with idiopathic scoliosis.

The objective of this study was to verify the accuracy of surface measurements to estimate the magnitude of sagittal curvature changes at follow-up. Ninety-seven patients with idiopathic scoliosis were evaluated at two different visits (interval: 15.7 months). Kyphosis and lordosis were measured on the lateral radiograph. Surface measurements rely on localization of spinous process landmarks using a video-based system. Multiple regression analyses were performed to estimate the sagittal curvatures on the second visit. The regression was significant for both kyphosis and lordosis. The mean absolute difference between the estimate and the radiologic measurement was 3.3 degrees for kyphosis and 3.2 degrees for lordosis. The difference between the estimated change and the observed change between visits showed mean absolute differences of 3.4 degrees and 2.7 degrees, respectively. The proposed strategy could be used during follow-up to reduce patient irradiation without loss of sagittal information.

A new porous titanium-nickel alloy: part 2. Sensitization, irritation and acute systemic toxicity evaluation.

Porous titanium-nickel (PTN) represents a new biomaterial with orthopedic applications as a long-term implant. Because of its nickel content, PTN was tested for its potential to stimulate sensitization, irritation, and systemic toxicity reactions after semi-physiological extraction. In order to do so, an in vivo biocompatibility evaluation was performed following three ISO-standardized methods using accepted animal models for immunity testing: the classical skin sensitization assay (Buehler patch test) in guinea pigs, the rabbit intracutaneous test, and the systemic injection test in mice. The Buehler patch test in guinea pigs revealed no significant change in skin reactions such as erythema or swelling between the induction and the challenge period. In the rabbit intracutaneous irritation test, no irritation or sensitization reactions were observed in saline-extracted PTN samples. Negligible to slight irritation was observed at some of the sites involving PTN samples extracted in cottonseed oil, however the resulting primary irritation index was similar to the one elicited by the blank solution itself. Finally, no toxic symptoms were observed with any of the mice injected with porous titanium-nickel extracts during the acute systemic toxicity test. Based on the above results, porous titanium-nickel is considered to be a non-sensitizing, non-irritant, and non-toxic biomaterial for medical applications.