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

Isthmic Spondylolisthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04559399
• Other study ID #: isthmic spondylolisthesis
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: Najib Al-shaea, MD
• Phone: 00201002784058
• Email: nageebalshaya[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Isthmic Spondylolisthesis
• Spondylolisthesis

Intervention

Procedure:
• smiley face shape rod
For treatment of isthmic spondylolithesis a transpedical screws for the same level and rod revolve around spinal process to stabilization of pars interarticularis of the same segment after removes bone at the margine of defects pars till reach to healthy bleed margine then put bone graft at the defect then stablizing pars and bone graft by rods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Bell DF, Ehrlich MG, Zaleske DJ. Brace treatment for symptomatic spondylolisthesis. Clin Orthop Relat Res. 1988 Nov;(236):192-8. — View Citation

Bonnici AV, Koka SR, Richards DJ. Results of Buck screw fusion in grade I spondylolisthesis. J R Soc Med. 1991 May;84(5):270-3. — View 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. — View Citation

Debnath UK, Freeman BJ, Gregory P, de la Harpe D, Kerslake RW, Webb JK. Clinical outcome and return to sport after the surgical treatment of spondylolysis in young athletes. J Bone Joint Surg Br. 2003 Mar;85(2):244-9. Review. — View Citation

Herman MJ, Pizzutillo PD, Cavalier R. Spondylolysis and spondylolisthesis in the child and adolescent athlete. Orthop Clin North Am. 2003 Jul;34(3):461-7, vii. Review. — View Citation

Karatas AF, Dede O, Atanda AA, Holmes L Jr, Rogers K, Gabos P, Shah SA. Comparison of Direct Pars Repair Techniques of Spondylolysis in Pediatric and Adolescent Patients: Pars Compression Screw Versus Pedicle Screw-Rod-Hook. Clin Spine Surg. 2016 Aug;29(7):272-80. doi: 10.1097/BSD.0b013e318277cb7d. — View Citation

Standaert CJ, Herring SA. Spondylolysis: a critical review. Br J Sports Med. 2000 Dec;34(6):415-22. Review. — View Citation

Widi GA, Williams SK, Levi AD. Minimally invasive direct repair of bilateral lumbar spine pars defects in athletes. Case Rep Med. 2013;2013:659078. doi: 10.1155/2013/659078. Epub 2013 Apr 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change pain	assessment of pain change one week postoperation by using visual analog scale (AVS) and MacNabs chart to assess degree of change	pain assess one week postoperation
Primary	radiological fusion of pars defect	using CT scan for fusion percentage assess at 6 month of postoperation.	6 month postoperative