Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05321186
Other study ID # Spinopelvic instability
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date June 1, 2023

Study information

Verified date April 2022
Source Assiut University
Contact Ahmed A A Hassan, MBBCh, MSc
Phone +201288103657
Email ahmedabdelazim2014@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the main aim of this study is to evaluate the results of performing minimally invasive surgical management for cases with traumatic spinopelvic instability and spinopelvic dissociation. This will include using percutaneous pedicle and S2 alar iliac screws, minimally invasive transforaminal lumbar interbody fusion and transtubular posterior decompression.


Description:

Study Procedure: 1. Patient enrollment and pre-operative evaluation: Upon Arrival, the patient will be managed in the emergency department according to the Advanced Trauma Life Support (ATLS) protocol. After achieving the haemodynamic stability, in cases of shock, X-rays (AP and lateral view of the lumbosacral region, inlet and outlet views of the pelvis) and CT scan of the pelvis will be performed. If the fracture pattern fits the inclusion criteria, the patient will be offered to enroll in the study and the patient will be prepared for surgery. 2. Surgery: The surgery will be performed under general anaesthesia and fluoroscopic guidance. The patients will be positioned prone on an open top of a radiolucent table with large bumps under the thighs to accentuate an extension force on the legs which will be the main reduction maneuver in the surgical procedure. Bilateral percutaneous L4 and L5 pedicle screws will be placed under fluoroscopic guidance with Jamshidi needles, and these were will also be used the iliac fixation via percutaneous S2 alar iliac screws. Cases presenting with significant instability, minimally invasive Transforaminal lumbar interbody fusion (MIS-TLIF) will be performed. Additionally, in cases with neurological deficit, posterior decompression will be performed. 3. Follow-up The patient will have four follow up visits (one and half month, 3month, 6month and 1 year) besides the discharge visit, during which the functional outcome scores will be filled out. AP and lateral view pelvis x-rays will be performed every visit. CT scan, AP and lateral scanograms will be only performed on the 1-year visit.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date June 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: Skeletally mature patients presenting with sacral fractures (provided that the fracture line passes below the level of S2) associated with lumbosacral instability showing one of the following: 1. Unilateral or bilateral L5-S1 facet fractures (AO classification type C1 and C2) 2. Spinopelvic dissociation (AO type C3) 3. Traumatic lumbosacral dislocation Exclusion Criteria: 1. unwillingness to participate in the study 2. pathological fractures 3. other medical comorbidities that preclude surgical intervention.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
minimally invasive spinopelvic fixation
Bilateral percutaneous L4 and L5 pedicle screws will be placed under fluoroscopic guidance with Jamshidi needles, and these were will also be used the iliac fixation via percutaneous S2 alar iliac screws. Cases presenting with significant instability, minimally invasive Transforaminal lumbar interbody fusion (MIS-TLIF) will be performed. Additionally, in cases with neurological deficit, posterior decompression will be performed.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Majeed pelvic score it is a patient reported outcome score used for functional assessment after pelvic fractures.The score ranges from 0 to 100 with 0 representing the most disability and 100 the best function. it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary Short Form 12 (SF-12) score it is a 12-item, patient-reported survey of patient health.The score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning. it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary Oswestry disability index (ODI): it is a Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary Visual analogue scale of pain (VAS) It is a patient reported tool for assessment of pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary AO PROST it is a specific patient reported outcome score designed for spine trauma patients.It consists of 19 questions on a broad range of aspects of functioning on a 0-100 numeric rating scale with 0 indicating no function at all and 100 the pre-injury level of function. it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary lumbar lordosis it will measured in degrees on plain standing lateral lumbosacral x-rays. it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary Gibbons' criteria it is a classification used to stratify patients with neurological deficit associated with pelvic injuries it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary pelvic incidence it will be measured in degrees on plain standing lateral lumbosacral x-rays. it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary AP translation it will be measured in millimetres on inlet and outlet pelvic x-rays. it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary vertical translation it will be measured in millimetres on plain standing AP pelvic x-rays. it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary sacral table angle it will be measured in degrees on plain standing lateral lumbosacral x-rays. it will be assessed at one and half month, three month, six month and one year after the surgery
Secondary sacral kyphosis angle it will be measured in degrees on plain standing lateral lumbosacral x-rays. it will be assessed at one and half month, three month, six month and one year after the surgery
See also
  Status Clinical Trial Phase
Recruiting NCT03253952 - A Study of Autonomic Dynamic Dysfunction to Predict Infections After Spinal Cord Injury.
Completed NCT06153511 - Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation N/A
Recruiting NCT03644407 - Galeazzi Spine Surgery RegistryGaleazzi Spine Registry: Prospective Study for Clinical Monitoring
Completed NCT03269851 - Parameters of Neurological Deficit After Thoracolumbar Fractures
Recruiting NCT03316703 - Surgical Treatment of the Thoracolumbar Spine Fractures. N/A
Completed NCT04123106 - Bilateral Erector Spinae Plane Block Versus Local Anesthetic Infiltration for Perioperative Analgesia in Spine Surgery. N/A
Completed NCT00994032 - Quality of Life After Vertebroplasty Versus Conservative Treatment in Patients With Painful Osteoporotic Vertebral Fractures N/A
Completed NCT00343252 - Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis Phase 3
Completed NCT02252185 - A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery N/A
Recruiting NCT05170815 - Clariance ErYs Registry
Not yet recruiting NCT04743869 - Calcium Phosphate Versus PMMA Cement in Thoracolumbar Fractures N/A
Terminated NCT03359941 - Acupuncture Treatment for Vertebral Compression Fracture N/A
Completed NCT03272243 - Short Segment vs Long Segment Fixation in Traumatic Dorsolumbar Spine Fractures N/A
Completed NCT00749242 - Comparative Study of Balloon Kyphoplasty and Conservative Treatment Phase 4
Not yet recruiting NCT03312998 - Incidence of Metal Failure During First Year Following Transpedicular Screws Fixation of Dorsolumbar Spine Fracture N/A
Recruiting NCT03911492 - Canadian-American Spinal Cord Perfusion Pressure and Biomarker Study N/A
Recruiting NCT05769114 - Surgical Versus Non-Surgical Treatment of Thoracolumbar Burst Fracture N/A
Recruiting NCT03593330 - Neurosurgical Transitional Care Programme N/A
Recruiting NCT06200298 - Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures N/A