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

Feinberg, Nicholas; Matsumoto, Hiroko; Hung, Chun Wai; Hilaire, Tricia St.; Pawelek, Jeff; Sawyer, Jeffrey R.; Akbarnia, Behrooz A.; Skaggs, David L.; Roye, Benjamin; Roye, David P.; Vitale, Michael G.

doi:10.1016/j.jspd.2017.11.002

Cited by 5 publications

(2 citation statements)

References 21 publications

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“…In addition, there are implant-associated factors, like metallosis and reduced gain in length over time, the consequences of which we do not yet have a clear understanding of. Propagated patient and treatment registries should be implemented, as should the proposal for a prospective randomized controlled trial, 36 to clarify these open questions and provide optimal protection for our patients.…”

Section: Discussionmentioning

confidence: 99%

Treatment of early onset spinal deformities with magnetically controlled growing rods: A single centre experience of 30 cases

Studer

Heidt

Büchler

et al. 2019

Journal of Children's Orthopaedics

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Purpose The treatment of early onset scoliosis continues to be a major challenge, even when using motorized growth-sparing implants. We report on 30 cases operated on with magnetically controlled growing rods (MCGRs) at our institution, analyzing radiological parameters and complications, comparing our results with the literature and presenting a special implant fixation technique. A separate focus highlights the challenges of conversion from previous non-motorized implants. Methods Consecutive case series. The nature and effects of complications were recorded for all patients. Radiographic evaluations were performed for patients with a minimum follow-up of two years. Separate analyses were carried out for patients who were previously treated with non-motorized growth-sparing implants Results There were 12 documented complications in 11/30 (37%) patients leading to 13 unplanned returns to the operating room. In all, 18/30 patients had a minimum follow-up of two years. Major curve and main kyphosis, as well as T1 to T12 and T1 to S1 distances significantly improved with MCGR implantation, however, less in patients converted from previous growth-sparing surgical treatment. While the achieved correction of the major curve was maintained, there was a loss of kyphosis correction with subsequent implant lengthening. Gain in implant length decreased with increasing number of extensions. Conclusion Despite improved patient’s comfort, MCGR show a considerable complication rate. Coronal plane deformities can be well controlled, but diminished implant lengthening is already apparent within two years after MCGR implantation. Central databases should help to clarify unresolved aspects and optimize the treatment of these young patients. Level of Evidence IV

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Section: Discussionmentioning

confidence: 99%

Treatment of early onset spinal deformities with magnetically controlled growing rods: A single centre experience of 30 cases

Studer

Heidt

Büchler

et al. 2019

Journal of Children's Orthopaedics

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“…There are some limitations to the present systematic review that warrant discussion. First, all included studies were case series, and none were randomized controlled trials [46]. Therefore, the current evidence is still of relative low quality.…”

Section: Discussionmentioning

confidence: 99%

Minimum 2-Year Experience with Magnetically Controlled Growing Rods for the Treatment of Early-Onset Scoliosis: A Systematic Review

Cheung

Lin

et al. 2019

Asian Spine J

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Magnetically controlled growing rods have been used to treat early-onset scoliosis for the last 9 years; however, few studies have been published, with only short-term follow-up. The aim of the present study is to systematically review the outcomes of magnetically controlled growing rods in the treatment of early-onset scoliosis with a minimum of 2-year follow-up. Studies were included if patients with early-onset scoliosis (scoliosis diagnosed before 10 years of age) underwent implantation of magnetically controlled growing rods with a minimum of 2-year follow-up. The literature review and data extraction followed the established preferred reporting items for systematic review and meta-analysis guidelines. Data of distraction frequency, number of distractions, distracted length, Cobb angle, kyphosis, T1–T12 length, and T1–S1 length preoperatively, postoperatively, and at final follow-up were collected. Data regarding complications and unplanned reoperations were also extracted. The mean values of these parameters were calculated, or pooled meta-analysis was performed if available. Ten articles were included in this systematic review, with a total of 116 patients and a follow-up period between 23 and 61 months. The mean preoperative Cobb angle and kyphosis angle were 60.1° and 38.0°, respectively, and improved to 35.4° and 26.1° postoperatively. At final follow-up, the Cobb and kyphosis angles were maintained at 36.9° and 36.0°, respectively. The average preoperative T1–T12 and T1–S1 lengths were 180.6 mm and 293.6 mm, respectively, and increased to 198.3 mm and 320.3 mm postoperatively. T1–T12 and T1–S1 lengths were 212.3 mm and 339.3 mm at final follow-up, respectively. The overall rate of patients with complications was 48% (95% confidence interval [CI], 0.38–0.58) and unplanned reoperation 44% (95% CI, 0.33–0.55) after sensitivity analysis. The current evidence from different countries with a minimum of a 2-year follow-up suggests that magnetically controlled growing rods are an effective technique to treat pediatric scoliosis and promote spine growth. However, nearly half of patients still developed complications or required unplanned reoperations.

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Expert Consensus for Early Onset Scoliosis Surgery

Hughes

Swarup

Makarewich

et al. 2019

Journal of Pediatric Orthopaedics

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Background: Despite a validated classification system, high-quality multicenter research databases (CSSG/GSSG), and a recent proliferation in publications, early-onset scoliosis (EOS) surgeons have no consensus on standards for surgical treatment. The 21st-century revolution in EOS care has only accelerated, with the arrival of a classification system, magnetically controlled growing rod, nusinersen, and improved nonoperative care (Mehta or Risser casting and compliance-monitored braces). This dizzying pace of change may have outstripped our ability to develop best-practice standards for EOS surgical indications. To learn where consensus is best (and worst) at this moment, we surveyed EOS world thought-leaders on a collection of representative cases. Methods: A 6-case survey was constructed and sent to 20 EOS world thought-leaders. The cases were selected to be representative of the major treatment categories: idiopathic, neuromuscular, syndromic, congenital, thoracic dysplasia, and spinal muscular atrophy (specifically to assess the impact of nusinersen and parasol deformity on surgical planning). Respondents were queried regarding treatment with specific attention to instrumentation and construct when surgery was selected. Responses regarding surgical timing and technique were analyzed for consensus (defined as >80%). χ2 analysis was performed to evaluate for differences in treatment preferences based on years of experience. Results: The survey response was 100%. Clinical experience ranged from 8 to 40 years (average 23.9 y). There was no consensus on any case. The greatest variability was on the congenital case; the closest to consensus was on the spinal muscular atrophy case. Three or more approaches were selected for all 6 cases; >4 approaches were selected for 5 cases. There is a trend towards screw fixation for proximal anchors. The management of thoracic dysplasia and parasol deformity is far from consensus. Conclusion: The lack of consensus for surgical treatment of 6 representative EOS cases demands a renewed effort and commitment to develop best-practice guidelines based on multicenter outcome data. Level of Evidence: Level V—Expert Opinion.

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

Abstract: Level V.

Cited by 5 publications

References 21 publications

Treatment of early onset spinal deformities with magnetically controlled growing rods: A single centre experience of 30 cases

Treatment of early onset spinal deformities with magnetically controlled growing rods: A single centre experience of 30 cases

Minimum 2-Year Experience with Magnetically Controlled Growing Rods for the Treatment of Early-Onset Scoliosis: A Systematic Review

Expert Consensus for Early Onset Scoliosis Surgery

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