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IRCT20230907059376N3 IRCT 2023-12-09 Afridi Medical Complex, Peshawar Comparison of transpedicular fixation with fusion with transpedicular fixation alone in spondylolisthesis: A Randomized Control Trial Comparison of Transpedicular fixation with fusion with transpedicular fixation alone in spondylolisthesis 2021-08-21 anticipated 28 Complete https://irct.ir/trial/74090 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were grouped based on center and randomly assigned using a computer-generated permuted-block system. Allocations were kept in opaque, coded, and sealed envelopes by a data manager who was not engaged in the patient selection or allocation process. Following randomization, the prepared envelope was opened, the patient was told of the assigned intervention, and the necessary preparations were made for the assigned intervention, Blinding description: In the Randomized Controlled Trial (RCT), outcome assessors were blinded through a meticulous process where they were kept unaware of participants' assigned interventions. This ensured the assessments were conducted objectively, minimizing bias and enhancing the reliability of the trial's results. N/A Spondylolisthesis. Intervention 1: Intervention group: Participants randomized to intervention group, undergoing Transpedicular Fixation with Fusion, will receive bilateral transpedicular fixation using pedicle screws, coupled with interbody fusion employing autograft or suitable bone substitute. This will be complemented by posterior stabilization using rods and cross-links. Intervention 2: Control group: Group B, designated for Transpedicular Fixation Alone, will involve bilateral transpedicular fixation with pedicle screws without interbody fusion, followed by posterior stabilization using rods and cross-links. Yes - There is a plan to make this available What will be shared: Data will be available in the document under the title name, "Transpedicular fixation with fusion vs Transpedicular fixation alone in spondylolisthesis: A Randomized Control Trial" When: Data will be available after study is published for a year. To whom: Data will be available for researchers and neurosurgeons as well as neuro physicians. Conditions: Data will be used by giving credit to the Principal investigator, Dr. Muhammad Idris Khan consultant Neurosurgeon. Where to obtain: Documents will be provided through email to the Principal author Dr. Muhammad Idrees Khan (idrisnsw83@gmail.com) How to obtain: Documents will be provided through email to the Principal author Dr. Muhammad Idrees Khan (idrisnsw83@gmail.com) Comments:
public Mahboob Khan
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
Peshawar Pakistan 25150 +92 91 5711751 mehboob509@gmail.com Afridi Medical Complex, Peshawar scientific Mahboob Khan
Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa
Peshawar Pakistan 25150 +92 91 5711751 mehboob509@gmail.com Afridi Medical Complex, Peshawar Pakistan First and second grade degenerative lumbar spondylolisthesis patients Patients who would consent to participating in the study under ethical conditions Both Gender Male and Female Age 18-45 years 18 years 45 years Male Patients with additional lumbar spondylolisthesis types Patients with additional lumbar degenerative spondylolisthesis grades (3rd and 4th grades) Patients with additional spine pathology (lumbar fracture, disc prolapse) Patients who respond to conservative treatment M43.1 Spondylolisthesis Treatment - Surgery Treatment - Surgery Intervention group: Participants randomized to intervention group, undergoing Transpedicular Fixation with Fusion, will receive bilateral transpedicular fixation using pedicle screws, coupled with interbody fusion employing autograft or suitable bone substitute. This will be complemented by posterior stabilization using rods and cross-links. Control group: Group B, designated for Transpedicular Fixation Alone, will involve bilateral transpedicular fixation with pedicle screws without interbody fusion, followed by posterior stabilization using rods and cross-links. Lumbar spine disability. Timepoint: Post-surgery for baseline and then after 6 and 12 months. Method of measurement: Oswestry Disability Index (ODI). Pain. Timepoint: Post-surgery for baseline and then after 6 and 12 months. Method of measurement: Visual analogue scale (VAS). Afridi Medical Complex, Peshawar Approved 2021-07-09 Afridi medical complex ethical commette Afridi medical complex tehkal payan, University Rd, Tehkal, Peshawar, Khyber Pakhtunkhwa 25150 Peshawar Khyber Pakhtunkhwa Pakistan