Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06279468
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-01-10
Brief Title:
Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis INDIRECT
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adolescent idiopathic scoliosis AIS poses challenges in achieving optimal three-dimensional correction While posterior fusion with pedicle screws has shown success osteotomy techniques such as Ponte osteotomy have further improved outcomes However residual vertebral rotation remains a concern impacting long-term complications Intervertebral disc release IDR presents a potential solution to enhance derotation and reduce fusion levels particularly in Lenke Type 5 AIS This prospective randomized controlled trial aims to evaluate the clinical effectiveness of IDR in treating Lenke 5 AIS comparing it to Ponte osteotomy The study focuses on axial vertebral rotation correction coronal curve improvement blood loss hospital stay and adverse events Participants aged 10-18 with Lenke 5 AIS will undergo either IDR or Ponte osteotomy randomly assigned Outcome measures include axial rotation correction rate radiographic parameters and clinical assessments A total of 132 participants will be recruited The IDR technique through posterior disc removal presents a promising approach to optimize derotation in Lenke 5 AIS While offering potential advantages challenges like limited working space and bleeding risks require careful consideration The studys findings aim to provide robust clinical evidence enhancing treatment strategies for Lenke 5 AIS and offering innovative approaches for AIS as a whole
Detailed Description:
Hypotheses To examine the clinical effectiveness of intervertebral disc release in treating Lenke 5 adolescent idiopathic scoliosis our working hypothesis posits that participants treated with intervertebral disc release achieve a higher rate of correction for axial vertebral rotation especially the rotation of the apex vertebrae demonstrate improved correction rate for coronal curve experience no additional blood loss or allogeneic transfusions and do not experience an increase in the length of hospital stay LOH or adverse event AE rate compared to individuals treated with Ponte osteotomy
Objectives Based on the aforementioned hypothesis this study aims to evaluate the clinical effectiveness of intervertebral disc release in treating Lenke 5 adolescent idiopathic scoliosis The evaluation includes assessing the efficacy of vertebral derotation and the change in Cobb angle following the correction surgery as well as perioperative blood loss transfusion volumerate length of hospital stay and the rate of adverse events AEs
Study setting and investigators The trial will take place at a tertiary care teaching hospital The study will be conducted in the wards and operating rooms of the orthopedic department which has 200 beds at this comprehensive hospital with a total of 2500 beds Participants will be recruited from the outpatient clinic by one investigator and will provide their consent to the investigators All investigators have practical experience in clinical orthopedic research projects A single team of surgeons who have completed a clinical fellowship in spinal surgery will perform the surgeries
Participants The study will enroll patients between the ages of 10 and 18 with an American Society of Anesthesiologists ASA physical status classification of I-II These patients will be diagnosed with Lenke 5 type adolescent idiopathic scoliosis and will require posterior correction internal fixation and bone graft fusion Enrollment in the study will be contingent upon signing a written informed consent
Patients with a history of previous corrective surgery or with sharp angulated short-segmental scoliosis and those with congenital scoliosis requiring 3-column osteotomy will be excluded Participants who experience dura mater laceration or unexpected massive bleeding during the operation will be excluded as well
Randomization and concealment Before commencing the study an independent researcher with no participant contact will utilize SAS 94 software SPSS Inc Chicago IL USA to generate a blocked random number table block size 4 This table will be used to allocate eligible participants in a 11 ratio to 2 groups A group designated as the IDR group will undergo subsequent intervertebral disc release following Ponte osteotomy on the predetermined vertebral levels whereas the PO group will solely undergo Ponte osteotomy
Data collection and monitoring The collected data will be entered into electronic case report forms eCRFs through a process of double data entry and logic validation Subsequently the eCRFs will be uploaded to a central server To uphold the trials quality standards a proficient clinical trial expert will be invited to perform audits of both the trial implementation process and data entry on a bimonthly basis The purpose of the regular audit is to ensure adherence to the protocol and Good Clinical Practices GCPs The expert may review source documents to verify the accuracy of the data recorded on CRFs During each audit all study records from the past 2 months will be thoroughly examined to ensure the quality of the trial conduct and the consistency between the source data and the data entered in the database This study will not include any interim analysis
Sample size and statistical analysis This trial will recruit 132 participants 66 participants per group to confirm the primary outcome equivalence between IDR group and PO group According to a prior study the correction rate of axial rotation of the apex vertebrae is 060023 Assuming that alpha 005 power 095 two-sided 95 CI and the follow-up loss 15 66 participants are needed for each group G-power software version 319 was used for calculating the sample size The primary outcome measures the correction rate of axial vertebral derotation The mean values and standard deviations of these outcomes will be calculated for both the intervention and control groups To assess the differences between the two groups independent sample t-tests or Mann-Whitney U tests will be performed Secondary outcomes measureå such as blood loss allogeneic transfusions length of hospital stay LOH and adverse events AEs will also be analyzed Continuous variables eg blood loss LOH will be analyzed using independent sample ttests or Mann-Whitney U tests while categorical variables eg allogeneic transfusions AEs will be analyzed using chi-square tests or Fishers exact tests as appropriate The difference between the IDR group and PO group will be reported as mean difference and lower one-sided 95 confidence interval CI along with a one-sided p 005 Statistical analyses will be conducted using SPSS
Dissemination plan The trial results will be submitted to an international peer-reviewed journal Additionally the findings will be presented at relevant national and international conferences
Objectives Based on the aforementioned hypothesis this study aims to evaluate the clinical effectiveness of intervertebral disc release in treating Lenke 5 adolescent idiopathic scoliosis The evaluation includes assessing the efficacy of vertebral derotation and the change in Cobb angle following the correction surgery as well as perioperative blood loss transfusion volumerate length of hospital stay and the rate of adverse events AEs
Study setting and investigators The trial will take place at a tertiary care teaching hospital The study will be conducted in the wards and operating rooms of the orthopedic department which has 200 beds at this comprehensive hospital with a total of 2500 beds Participants will be recruited from the outpatient clinic by one investigator and will provide their consent to the investigators All investigators have practical experience in clinical orthopedic research projects A single team of surgeons who have completed a clinical fellowship in spinal surgery will perform the surgeries
Participants The study will enroll patients between the ages of 10 and 18 with an American Society of Anesthesiologists ASA physical status classification of I-II These patients will be diagnosed with Lenke 5 type adolescent idiopathic scoliosis and will require posterior correction internal fixation and bone graft fusion Enrollment in the study will be contingent upon signing a written informed consent
Patients with a history of previous corrective surgery or with sharp angulated short-segmental scoliosis and those with congenital scoliosis requiring 3-column osteotomy will be excluded Participants who experience dura mater laceration or unexpected massive bleeding during the operation will be excluded as well
Randomization and concealment Before commencing the study an independent researcher with no participant contact will utilize SAS 94 software SPSS Inc Chicago IL USA to generate a blocked random number table block size 4 This table will be used to allocate eligible participants in a 11 ratio to 2 groups A group designated as the IDR group will undergo subsequent intervertebral disc release following Ponte osteotomy on the predetermined vertebral levels whereas the PO group will solely undergo Ponte osteotomy
Data collection and monitoring The collected data will be entered into electronic case report forms eCRFs through a process of double data entry and logic validation Subsequently the eCRFs will be uploaded to a central server To uphold the trials quality standards a proficient clinical trial expert will be invited to perform audits of both the trial implementation process and data entry on a bimonthly basis The purpose of the regular audit is to ensure adherence to the protocol and Good Clinical Practices GCPs The expert may review source documents to verify the accuracy of the data recorded on CRFs During each audit all study records from the past 2 months will be thoroughly examined to ensure the quality of the trial conduct and the consistency between the source data and the data entered in the database This study will not include any interim analysis
Sample size and statistical analysis This trial will recruit 132 participants 66 participants per group to confirm the primary outcome equivalence between IDR group and PO group According to a prior study the correction rate of axial rotation of the apex vertebrae is 060023 Assuming that alpha 005 power 095 two-sided 95 CI and the follow-up loss 15 66 participants are needed for each group G-power software version 319 was used for calculating the sample size The primary outcome measures the correction rate of axial vertebral derotation The mean values and standard deviations of these outcomes will be calculated for both the intervention and control groups To assess the differences between the two groups independent sample t-tests or Mann-Whitney U tests will be performed Secondary outcomes measureå such as blood loss allogeneic transfusions length of hospital stay LOH and adverse events AEs will also be analyzed Continuous variables eg blood loss LOH will be analyzed using independent sample ttests or Mann-Whitney U tests while categorical variables eg allogeneic transfusions AEs will be analyzed using chi-square tests or Fishers exact tests as appropriate The difference between the IDR group and PO group will be reported as mean difference and lower one-sided 95 confidence interval CI along with a one-sided p 005 Statistical analyses will be conducted using SPSS
Dissemination plan The trial results will be submitted to an international peer-reviewed journal Additionally the findings will be presented at relevant national and international conferences
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None