“…Sixteen studies reported the major curve pre- and post-operation and at final follow-up 13,14,22,23,25,28–31,34,35,37,38,41,43,45 (Figure 3). Ten studies reported kyphosis angle pre- and post-operation and at final follow-up 13,14,23,28,30,34,37,38,41,45 (Figure 4). Figure 2.Illustration of vertebral body tethering.…”
Section: Resultsmentioning
confidence: 99%
“…14,22–24,26,27,29,31,32,34–36,39,43 Twelve studies involving 464 patients had a mean follow-up time of >36 months. 13,25,28,30,33,37,38,40–42,44,45…”
Section: Resultsmentioning
confidence: 99%
“…VBT can achieve certain deformity correction during the initial operation, control the patient's spinal growth potential, and make the concave side grow faster than the convex side, thereby realizing continuous correction during subsequent spinal growth while controlling the progression of deformity (Figure 2). Sixteen studies reported the major curve pre-and post-operation and at final follow-up 13,14,22,23,25,[28][29][30][31]34,35,37,38,41,43,45 (Figure 3). Ten studies reported kyphosis angle pre-and post-operation and at final follow-up 13,14,23,28,30,34,37,38,41,45 (Figure 4).…”
Purpose Over the past 12 years, vertebral body tethering (VBT) has been gradually promoted for treating scoliosis, but there are few published studies, with only short-term follow-up. This study aimed to systematically review VBT efficacy and safety for treating scoliosis. Methods PubMed, Web of Science, Embase, and the Cochrane Library were searched for studies on VBT treatment of scoliosis published up to November 2021. Two researchers independently screened the literature, extracted data, and assessed the risk of bias in included studies. Data on clinical efficacy, unplanned reoperations, and complications were extracted. The meta-analysis was performed with R 4.1.0. Results Twenty-six studies involving 1045 patients were included in the meta-analysis. The correction rate of major curve immediately post-operation was 46.6% ± 13.8% (16%–69%) and that at final follow-up was 53.2% ± 17.9% (16%–79%). The single-arm meta-analysis results of all included studies showed that VBT was effective in general. The overall clinical success rate was 73.02% (95% confidence interval [CI]: 68.31%–78.05%). The pooled overall unplanned reoperation rate was 8.66% (95% CI: 5.53%–13.31%). The overall incidence rate of complications was 36.8% (95% CI: 23.9%–49.7%). The subgroup analysis based on follow-up time indicated that patients with follow-up time >36 months had increased clinical success rate, unplanned reoperation rate, and incidence rate of complications compared with those with <36 months’ follow-up time. The preliminary results showed that after 36 months of follow-up, only 7.17% (95% CI: 4.81%–10.55%) of patients required posterior spinal fusion (PSF) surgery and nearly 93% of patients avoided spinal fusion surgeries. Conclusions The current evidence from at least 3-year follow-up in different countries indicates that VBT is an effective surgical approach for treating scoliosis, with 73.88% of patients achieving clinical success. Nevertheless, about one in seven patients (15.8%) required unplanned reoperations, but only 7.17% required PSF. About half (52.17%) of the patients experienced complications. Due to the limitation of the study number and quality, our conclusion may be biased and requires verification by further studies with longer follow-up times.
“…Sixteen studies reported the major curve pre- and post-operation and at final follow-up 13,14,22,23,25,28–31,34,35,37,38,41,43,45 (Figure 3). Ten studies reported kyphosis angle pre- and post-operation and at final follow-up 13,14,23,28,30,34,37,38,41,45 (Figure 4). Figure 2.Illustration of vertebral body tethering.…”
Section: Resultsmentioning
confidence: 99%
“…14,22–24,26,27,29,31,32,34–36,39,43 Twelve studies involving 464 patients had a mean follow-up time of >36 months. 13,25,28,30,33,37,38,40–42,44,45…”
Section: Resultsmentioning
confidence: 99%
“…VBT can achieve certain deformity correction during the initial operation, control the patient's spinal growth potential, and make the concave side grow faster than the convex side, thereby realizing continuous correction during subsequent spinal growth while controlling the progression of deformity (Figure 2). Sixteen studies reported the major curve pre-and post-operation and at final follow-up 13,14,22,23,25,[28][29][30][31]34,35,37,38,41,43,45 (Figure 3). Ten studies reported kyphosis angle pre-and post-operation and at final follow-up 13,14,23,28,30,34,37,38,41,45 (Figure 4).…”
Purpose Over the past 12 years, vertebral body tethering (VBT) has been gradually promoted for treating scoliosis, but there are few published studies, with only short-term follow-up. This study aimed to systematically review VBT efficacy and safety for treating scoliosis. Methods PubMed, Web of Science, Embase, and the Cochrane Library were searched for studies on VBT treatment of scoliosis published up to November 2021. Two researchers independently screened the literature, extracted data, and assessed the risk of bias in included studies. Data on clinical efficacy, unplanned reoperations, and complications were extracted. The meta-analysis was performed with R 4.1.0. Results Twenty-six studies involving 1045 patients were included in the meta-analysis. The correction rate of major curve immediately post-operation was 46.6% ± 13.8% (16%–69%) and that at final follow-up was 53.2% ± 17.9% (16%–79%). The single-arm meta-analysis results of all included studies showed that VBT was effective in general. The overall clinical success rate was 73.02% (95% confidence interval [CI]: 68.31%–78.05%). The pooled overall unplanned reoperation rate was 8.66% (95% CI: 5.53%–13.31%). The overall incidence rate of complications was 36.8% (95% CI: 23.9%–49.7%). The subgroup analysis based on follow-up time indicated that patients with follow-up time >36 months had increased clinical success rate, unplanned reoperation rate, and incidence rate of complications compared with those with <36 months’ follow-up time. The preliminary results showed that after 36 months of follow-up, only 7.17% (95% CI: 4.81%–10.55%) of patients required posterior spinal fusion (PSF) surgery and nearly 93% of patients avoided spinal fusion surgeries. Conclusions The current evidence from at least 3-year follow-up in different countries indicates that VBT is an effective surgical approach for treating scoliosis, with 73.88% of patients achieving clinical success. Nevertheless, about one in seven patients (15.8%) required unplanned reoperations, but only 7.17% required PSF. About half (52.17%) of the patients experienced complications. Due to the limitation of the study number and quality, our conclusion may be biased and requires verification by further studies with longer follow-up times.
“…With the HDE approval, there is now much greater ability to present and publish on results of VBT and for surgeons to learn from each other how to optimize the technique and the patient selection criteria to improve outcomes and reduce reoperations. Researchers have been able to publish on early complications, learning curve, preservation of spinal mobility, and disc health 15,18–22. Further, with the HDE approval, industry educational courses are now offered so that surgeons can be trained in the procedure.…”
Section: Discussionmentioning
confidence: 99%
“…Researchers have been able to publish on early complications, learning curve, preservation of spinal mobility, and disc health. 15,[18][19][20][21][22] Further, with the HDE approval, industry educational courses are now offered so that surgeons can be trained in the procedure. The FDA HDE approval of a device supports safety of a device, but not efficacy.…”
Surgeons should thoughtfully consider whether to introduce a new procedure into their practice. Considerations include the severity of the condition, potential risk of harm, treatment alternatives, patient population, ability to appropriately consent patient/families, and available clinical and institutional resources as well as published evidence and regulatory status. Whenever possible, new procedures should be standardized, studied, and reported upon so that the greater community can learn from experience and refine the indications to minimize risks for future patients. Small scale innovation can readily be introduced into practice. Surgeons should always strive to systemically study new procedures so as to be able to assess benefits and effects.
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