Smiley Face Shaped Rod Technique Versus Instrumented Posteriolateral Fusion in Treatment of Isthmic Lumbar Spondylolisthesis

Not Applicable

• Conditions: Isthmic Spondylolisthesis

• Registration Number: NCT04559399
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-21
• Last Update Submitted: 2020-09-21
• Study First Posted: 2020-09-22
• Last Update Posted: 2020-09-22
• Study Start: 2020-10-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
change pain	pain assess one week postoperation	assessment of pain change one week postoperation by using visual analog scale (AVS) and MacNabs chart to assess degree of change
radiological fusion of pars defect	6 month postoperative	using CT scan for fusion percentage assess at 6 month of postoperation.