Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202404611444119 Date of Approval: 03/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study of low density versus high density pedicular screw implantations in management of adolescent idiopathic Scoliosis
Official scientific title Comparative study of low density versus high density pedicular screw implantations in management of adolescent idiopathic Scoliosis: A randomized clinical trial
Brief summary describing the background and objectives of the trial Adolescent idiopathic scoliosis (AIS) is considered the most common spinal deformity in adolescents, with an incidence of 1-3% in the 10-16 year age group, and its etiopathogenesis remains unknown. Because trans-pedicular spinal fusion (TPSF) provides better three-dimensional correction of AIS in terms of radiographic and clinical outcomes along with a lower revision rate compared to hybrid implantation, TPSF has become the primary surgical strategy for correction of most cases of AIS. The significant correlation between implant density (number of screws per vertebral level) and major curve correction has been reported, with high-density (HD) screws showing better restoration of thoracic kyphosis and better Spinal Appearance Questionnaire scores. However, numerous studies have shown that low-density (LD) implants (screw density ≤1.5) can provide similar radiographic and clinical outcomes with significant reductions in cost, hospital stay, operative time, and blood loss. Therefore, the purpose of this study was to compare LD pedicle screw implants with HD pedicle screw implants in the correction of deformity in adolescent idiopathic scoliosis with respect to clinical, radiologic, and Scoliosis Research Society-22 outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/06/2022
Actual trial start date 01/06/2022
Anticipated date of last follow up 31/01/2024
Actual Last follow-up date 31/01/2024
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group HD group During the surgery Patients underwent posterior spinal fusion and deformity correction with screw density more than 1.5 (screw density defined as number of screws inserted divided by number of fused levels. e.g.,19 screws inserted and 11 levels fused so implant density is 1.7) 10 Active-Treatment of Control Group
Experimental Group LD group During the surgery Patients underwent posterior spinal fusion and deformity correction with screw density ≤ 1.5 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients diagnosed as adolescent idiopathic scoliosis Age between 10 and 18 years old Posterior spinal fusion with all pedicle screw constructs Cobb angle < 40 degrees No previous spinal surgery Absence of thoracoplasty Nine months follow-up in radiographic and SRS−22 outcomes Non idiopathic scoliosis Cobb angle > 40 degrees Associated congenital anomalies Contraindication of anesthesia Coagulopathy Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 10 Year(s) 18 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/05/2022 Research Ethics Committee Faculty of Medicine Beni Suef University
Ethics Committee Address
Street address City Postal code Country
Qism Beni Suef Beni Suef 62511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cobb angle assessed radiologically preoperatively, postoperatively, and at final follow-up at 9-month
Primary Outcome Operating time, Implant density, Number of fused levels, and Number of screws assessed at the end of the surgery
Primary Outcome Hospital stay assessed at discharge of the patient
Secondary Outcome Quality of life Scoliosis assessed by the SRS-22r questionnaire preoperatively and at final follow-up at 9-month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Beni Suef University Hospital Qism Beni Suef Beni Suef Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Abdelrhman Moustafa Qism Beni Suef Beni Suef Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Beni Suef University Hospital Qism Beni Suef Beni Suef Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdelrhman Moustafa abdelrhman.s.moustafa@email.com +201145796506 Qism Beni Suef
City Postal code Country Position/Affiliation
Beni Suef Egypt Neurosurgery Department Faculty of Medicine Beni Suef University
Role Name Email Phone Street address
Scientific Enquiries Abdelrhman Moustafa abdelrhman.s.moustafa@email.com +201145796506 Qism Beni Suef
City Postal code Country Position/Affiliation
Beni Suef Egypt Neurosurgery Department Faculty of Medicine Beni Suef University
Role Name Email Phone Street address
Public Enquiries Ahmed Koheil ahmed.koheil@mail.com +201061277988 Qism Beni Suef
City Postal code Country Position/Affiliation
Beni Suef Egypt Neurosurgery Department Faculty of Medicine Beni Suef University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share individual de-identified participant data. The datasets generated and/or analyzed during the current study will be available from the corresponding author upon reasonable request, beginning 12 months and ending 24 months after publication of the article. Study Protocol From 12 to 24 months after article publication Data will be made available to researchers for use in systematic reviews or meta-analyses upon reasonable request to the corresponding author.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information