Clinical trial NCT04559399: Smiley Face Shaped Rod Technique Versus Instrumented Posteriolateral Fusion in Treatment of Isthmic Lumbar Spondylolisthesis
Official title: Smiley Face Shaped Rod Technique Versus Instrumented Posteriolateral Fusion in Treatment of Isthmic Lumbar Spondylolisthesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Isthmic Spondylolisthesis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: all patients confirmed diagnosis and including criteria of intervention divided randomly in to 2 groups,control group include patients treat by transpedical screw and rod fixation and experimental group include patients treats smiley face rod technique and then clinical and radiological follow up for 6 month.

the varibals that will be measure are:

1. intraoperative variables :length of wound,blood loss and time of operation.
2. clinical outcome:pain and disability
3. radiological variables :fusion and degenerative of the adjacent level
Primary purpose: TREATMENT

Brief summary: Aim of research is to investigates clinical, surgical and radiological outcome of vertebral pars intetarticularis repair by used smile face shape rod technique and bone grafting and comparing that with posteriolateral fusion with used traditional transpedical screw and rod fixation in management of isthmic spondylistheisis

Detailed description: Isthmic spondylolisthesis is considered to represent a fatigue fracture of the pars interarticularis of the neural arch, The clinical symptom is activity-related back pain in young and athletic patients . The cause of Isthmic spondylolisthesis in these patients is repetitive stress of the pars interarticularis with subsequent microfracture, which in turn may lead to a bony defect and cause progressive spondylolisthesis in up to 25% of cases. Surgical intervention is indicated for patients who are not responsive despite adequate period of conservative management such as activity modification , physical therapy, and occasionally bracing .

Techniques for repair of a pars defect include Scott wiring , a Buck screw , a pedicle screw and hook , multiple segment fixations or a U-rod . After repair, radiographic healing rates range from 67 percent to 90 percent; asymptomatic and return to sports rates range from 80 percent to 90 percent.

These methods have achieved variable success .In Buck screw fusion surgery,it is not effect on flexion and axial rotation of the spine but bone healing is compromised.

Stabilization with wiring and titanium cable had less success rate than other methods and requires the use of lumbar brace or prolonged immobilization.

The pedicle screw-vertebral plate hook system may complicated by injury to the dural sac or nerves ensues.

Multiple segment fixation with pedicle screws and rods has good success of stabilization but it is effect on flexion and axial rotation of the spine, and may cause degenerative change in adjacent normal segments.

Smiley face shaped rod technique is new method used for repair of isthmic spodylolisthesis using pedical screw on effected segment and smiley face rod revolve around spinal process to stabilization of pars interarticularis of the same segment so it preserve axial rotation and flexion of spin also avoid degenerative change in adjacent levels.

Eligibility criteria: Inclusion Criteria:

1. age above 18 years old
2. Both sex
3. failure of conservative treatment for 3months
4. fit for surgery

Exclusion Criteria:

1. age less than 18
2. Not fit for surgery
3. pathological fracture of pars
4. assosciated pathology like disc degeneration, spinal canal stenosis, spondylolisthesis grad 2,3and 4

Primary outcomes:
measure: change pain
timeFrame: pain assess one week postoperation
measure: radiological fusion of pars defect
timeFrame: 6 month postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: Chen XS, Zhou SY, Jia LS, Gu XM, Fang L, Zhu W. A universal pedicle screw and V-rod system for lumbar isthmic spondylolysis: a retrospective analysis of 21 cases. PLoS One. 2013 May 17;8(5):e63713. doi: 10.1371/journal.pone.0063713. Print 2013.