Dataset Information

Surgical treatment of neuromuscular Early Onset Scoliosis with a bilateral posterior one-way rod compared to the Spring Distraction System: study protocol for a limited-efficacy Randomized Controlled Trial (BiPOWR).

ABSTRACT:

Background

Early Onset Scoliosis (EOS) is a progressive spinal deformity in children, and a potentially life-threatening disease. "Growth-friendly" surgical techniques aim to control the deformity, while allowing the spine and trunk to maintain growth. Current "growth-friendly" systems such as the traditional growing rod (TGR) and magnetically controlled growing rod (MCGR) have limitations that reduce their efficacy and cost-effectiveness. Recently, two "growth-friendly" systems have been developed that mitigate many of these limitations, the Spring Distraction System (SDS) and the One Way Self-Expanding Rod (OWSER). The purpose of the multicenter BiPOWR trial is to investigate, describe and compare the 1-year limited-efficacy and -safety of both strategies in the treatment of neuromuscular EOS.

Methods

After informed consent, 28 neuromuscular EOS patients will be randomized to receive either the SDS or the OWSER. Patients and caregivers will be blinded to allocation until after surgery. Primary outcomes will be maintenance of coronal curve correction and the occurrence of serious adverse events. In addition, spinal growth, implant lengthening, and perioperative findings are recorded systematically. At each follow-up moment, the Early Onset Scoliosis Questionnaire (EOSQ-24) will be used to assess health-related quality of life. All outcomes will be compared between groups.

Discussion

The BiPOWR trial is the first randomized controlled trial that compares two specific "growth-friendly" implants in a specified EOS population. It will determine the 1-year limited-efficacy and safety of the SDS and OWSER implants.

Trial registration

Clinicaltrials.gov: NCT04021784 (13-06-2019). CCMO registry: NL64018.041.17 (06-05-2019).

SUBMITTER: Lemans JVC

PROVIDER: S-EPMC9830923 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Surgical treatment of neuromuscular Early Onset Scoliosis with a bilateral posterior one-way rod compared to the Spring Distraction System: study protocol for a limited-efficacy Randomized Controlled Trial (BiPOWR).

Lemans Justin V C JVC Tabeling Casper S CS Scholten E Pauline EP Stempels Hilde W HW Miladi Lotfi L Castelein René M RM Kruyt Moyo C MC

BMC musculoskeletal disorders 20230110 1

<h4>Background</h4>Early Onset Scoliosis (EOS) is a progressive spinal deformity in children, and a potentially life-threatening disease. "Growth-friendly" surgical techniques aim to control the deformity, while allowing the spine and trunk to maintain growth. Current "growth-friendly" systems such as the traditional growing rod (TGR) and magnetically controlled growing rod (MCGR) have limitations that reduce their efficacy and cost-effectiveness. Recently, two "growth-friendly" systems have bee ...[more]

PMID: 36627616

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Project description:BackgroundMagnetically controlled growing rods (MCGRs) offer non-invasive distractions in Early-Onset Scoliosis (EOS). However, implant-related complications are common, reducing its cost-effectiveness. To improve MCGRs functionality and cost-effectiveness, we often combine a single MCGR with a contralateral sliding rod (hybrid MCGR). Recently, we developed the spring distraction system (SDS) as an alternative, which provides continuous distraction forces through a helical spring. This study aims to identify complication rates and failure modes of EOS patients treated with either of these innovative systems.MethodsThis single-centre retrospective study included EOS patients treated with a (hybrid) MCGR or SDS between 2013 and 2018. Baseline demographics, and data regarding complications and implant growth were measured. Complication rate, complication profile, complication-free survival and implant growth were compared between groups.ResultsEleven hybrid- and three bilateral MCGR patients (4.1-year follow-up) and one unilateral, eleven hybrid and six bilateral SDS patients (3.0-year follow-up) were included. Groups had similar age, sex, aetiology distribution, and pre-operative Cobb angle. Complication rate was 0.35 complications/patient/year for MCGR patients and 0.33 complications/patient/year for SDS patients. The most common complications were failure to distract (MCGR-group; 8/20 complications) and implant prominence (SDS-group; 5/18 complications). Median complication-free survival was 2.6 years, with no differences between groups (p = 0.673). Implant growth was significantly higher in the SDS-group (10.1 mm/year), compared to the MCGR-group (6.3 mm/year).Conclusion(Hybrid) MCGR and SDS patients have similar complication rates and complication-free survival. Complication profile differs between the groups, with frequent failure to distract leading to significantly reduced implant growth in (hybrid) MCGR patients, whereas SDS patients frequently exhibit implant prominence and implant kyphosis.Level of evidenceIII.

Project description:BackgroundThe current surgical treatment for patients diagnosed with progressive and severe adolescent idiopathic scoliosis (AIS) consists of the correction of the spinal curvature, followed by posterior spinal fusion (PSF). However, research has uncovered short- and long-term complications of posterior spinal fusion in patients with AIS. Minimally invasive growing rod techniques have successfully been used to treat patients with early-onset scoliosis and neuromuscular scoliosis. It may be questioned if minimally invasive posterior spinal nonfusion (PSnF) surgery with bipolar instrumentation can be used for the treatment of AIS.ObjectiveThis study will be performed to monitor the efficacy and safety of PSnF surgery by using a commercially available Conformité Européenne-certified spinal implant consisting of bilateral bipolar one-way self-expanding rods (OWSER) for the treatment of patients diagnosed with AIS.MethodsIn 14 selected patients with AIS with Lenke 1-6 curves, minimally invasive PSnF surgery with the OWSER system is performed after the failure of conservative treatment (curve progression of >5° within 1 year). The patients are over 7 years of age, with a major Cobb angle of ≥30°, sufficient flexibility, and a Risser stage of ≤2. Patients will be followed over time, according to the standard medical care. Efficacy will be measured using radiological and patient satisfaction assessments and safety will be determined by the amount of perioperative complications.ResultsPatient inclusion started on November 17, 2021 and we hope to finalize patient inclusion by the beginning of 2025. The first results will be expected by the beginning of 2024.ConclusionsMinimally invasive PSnF in patients with AIS is presented as a less invasive surgical technique that prevents the progression of the scoliotic curve and that allows minor posture correction of coronal imbalance. This will be the first study to examine whether the PSnF bipolar OWSER instrumentation will be the next generation of surgical instrumentation in AIS.Trial registrationClinicalTrials.gov NCT04441411; https://clinicaltrials.gov/study/NCT04441411.International registered report identifier (irrid)DERR1-10.2196/47222.

Project description:BackgroundSurgical management of adolescent idiopathic scoliosis (AIS) can be performed using standard posterior spinal fusion (PSF) or with a posterior minimally invasive approach. Minimally invasive scoliosis surgery (MISS) has several theoretical advantages, such as less tissue dissection, less blood loss, and earlier recovery. However, the difference in safety and effectiveness between MISS and PSF still needs to be clarified. This updated meta-analysis aimed to compare the outcomes of MISS and standard PSF for the management of AIS.MethodsA comprehensive literature search of PubMed, EMBASE, MEDLINE, and Cochrane Library without time restriction was performed to identify relevant studies. MISS and PSF were compared in terms of radiographic parameters, estimated blood loss (EBL), blood transfusion rate, operative time (ORT), length of hospital stay (LOS), overall Scoliosis Research Society-22 (SRS-22) score, postoperative pain, and complication rate.ResultsA total of seven studies comprising 767 patients (329 MISS and 438 PSF) with AIS were included. MISS and PSF yielded comparable deformity correction at the last follow-up. There were no significant differences in the overall SRS-22 scores or complication rates between the groups. Nevertheless, greater restoration of thoracic kyphosis (WMD, 2.98; 95% CI 0.58 to 5.37, P = 0.015), less EBL (WMD, -218.76; 95% CI -256.41 to -181.11, P < 0.001), a lower blood transfusion rate (RR, 0.31; 95% CI 0.20 to 0.48, P < 0.001), a shorter LOS (WMD, -1.48; 95% CI -2.48 to -0.48, P = 0.004), less postoperative pain (WMD, 0.57; 95% CI 0.16 to 0.98, P = 0.006), and a longer ORT (WMD, 84.85; 95% CI 33.30 to 136.40, P = 0.001) were observed in the MISS group.ConclusionDespite its inherent technical challenges, MISS is a feasible and effective alternative to standard PSF for AIS patients with moderate and flexible curves. MISS was associated with adequate deformity correction, better restoration of sagittal alignment, less EBL, fewer transfusions, shorter LOS, and better pain management compared to PSF. Further research is required to determine the detailed indications for the MISS procedure.

Dataset Information

Surgical treatment of neuromuscular Early Onset Scoliosis with a bilateral posterior one-way rod compared to the Spring Distraction System: study protocol for a limited-efficacy Randomized Controlled Trial (BiPOWR).

Background

Methods

Discussion

Trial registration

Publications

Surgical treatment of neuromuscular Early Onset Scoliosis with a bilateral posterior one-way rod compared to the Spring Distraction System: study protocol for a limited-efficacy Randomized Controlled Trial (BiPOWR).

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