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.: PACTR202211721074384 Date of Approval: 30/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Anterior Lumbar Interbody Fusion versus Posterior Transforaminal Lumbar Interbody Fusion for treatment of Lumbar Degenerative Diseases.
Official scientific title Anterior Lumbar Interbody Fusion versus Posterior Transforaminal Lumbar Interbody Fusion for treatment of Lumbar Degenerative Diseases.
Brief summary describing the background and objectives of the trial Degenerative lumbar spine diseases cause major functional disability. Fusion is the cornerstone of management for an unstable degenerative spinal disease; however, various techniques are available either anterior or posterior. The posterior approach is used to achieve posterior interbody fusion; however, to avoid direct manipulation of the nerves, Anterior Lumbar Interbody Fusion approaches were introduced to maintain spinal fusion and indirect decompression. Compared to open posterior surgery, these surgical approaches lessen postoperative back pain, surgical procedures time, and blood loss. The retroperitoneal approach in ALIF, is performed between the deep side of the rectus abdominis and the peritoneum, either right or left for L5S1 and left for upper or multiple levels L2-5; however in the anterior to psoas technique (ATP), it is through the external, internal oblique and transverse muscle fibres to the retroperitoneal space. In ALIF, the access to the disc space is direct anterior through anterior longitudinal ligament, however in ATP, it follows an oblique trajectory to the anterolateral side of the annulus. Both approaches can be used between L2 -S1 but ATP is more challenging at L5 - S1as high iliac crest, this can managed by folding the table towards the feet to create enough space and by using curved instruments which can go under the iliac crest (7). ATP tries to prevent disturbance of the psoas and lumbosacral plexus in the direct lateral trans-psoas approaches by following an oblique trajectory. ATP also avoids the vascular manipulation, which enables many spine surgeons to operate without vascular surgeon assistance. Our aim in this study is to investigate which technique is safer, less invasive and more effective in achieving patient satisfaction, sagittal realignment and higher fusion rate.
Type of trial CCT
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 25/10/2022
Actual trial start date 25/10/2022
Anticipated date of last follow up 24/07/2024
Actual Last follow-up date 04/12/2024
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Anterior lumbar fusion ALIF OLIF 2 years the outcome of the Anterior lumbar fusion ALIF OLIF compared with posterior fusion 50
Control Group Posterior TLIF 2 years Outcome of posterior fusion by TLIF 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All cases operated upon for degenerative lumbar spinal disorders by anterior lumbar fusion either ALIF or ATP during 2015 to 2023, in addition to, a group of TLIF cases matched the same criteria ( diagnosis, level, number of levels, age group,…) treated within the same period. All approaches are used for management of degenerative spinal diseases according to the surgical experience and preference - Previous abdominal surgery with severe adhesion. - Non degenerative spinal pathology or severe osteoporosis or severe peripheral vascular disease - Patient with incomplete files or in complete follow up Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 89 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
No 25/10/2022 Assiut University Fuculty of mwdicine
Ethics Committee Address
Street address City Postal code Country
Libraries Street, Markaz El-Fath, Assiut Governorate Assiut 71515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Lumbar fusion rate. Bridwell interbody fusion grading system is the basis for the fusion rate-grading criterion. Grades I and II as successful grades Lumbar fusion rate. Bridwell interbody fusion grading system is the basis for the fusion rate-grading criterion. Grades I and II as successful grades
Secondary Outcome • Radiological evaluation: including ADH, PDH, SLA, and FH before the surgery and at the last follow up along with cage position only at the post-operative serial follow up X. rays. • Surgical procedures and complications including operative time, blood loss, number of surgeries. Complications, intraoperative complication (anaesthesia, dural tear, neurological lesion, vascular injury or visceral injury), Postoperative complications: superficial infection, deep infection, neurological lesion, vascular lesion, hematoma, ipsilateral psoas paresis, ipsilateral quadriceps weakness, left lower abdominal pain, incomplete ileus, sympathetic chain symptom, metal malposition and cage shifting. Adverse effects: death, deep venous thrombosis, pulmonary embolism, pneumonia, urinary infection, acute respiratory insufficiency, multiple organ failure, sepsis, implant breakage or loosening, and need for reoperation. Radiological evaluation: including ADH, PDH, SLA, and FH
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut university Libraries Street, Markaz El-Fath, Assiut Governorate Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded Assiut university Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Assiut university Libraries Street, Markaz El-Fath, Assiut Governorate Assiut Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mostafa Abdelghafor mmghafoorhassanien@aun.edu.eg 00447719641922 Assiut, mahmoud rashwan st
City Postal code Country Position/Affiliation
Assiut Egypt Doctor
Role Name Email Phone Street address
Scientific Enquiries Mohammad ElSharkawi sharkoran@aun.edu.eg 00201005075855 assiut
City Postal code Country Position/Affiliation
Assiut Egypt Professor MD
Role Name Email Phone Street address
Public Enquiries Yousef Saleh youssef66@aun.edu.eg +20882413232 Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Vice Dean for Graduate Studies and Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data will be available including the Study Protocol, Statistical Analysis, and plan. This will be done after the deidentification of the participants, Immediately following the publication. Data will be available to researchers who provide a sound proposal. Statistical Analysis Plan,Study Protocol Immediately following publication( 3) years Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
After publication 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