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

NCT04559399 | Unknown

• 1 other identifier: isthmic spondylolisthesis
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Isthmic Spondylolisthesis

Outcome Measures

Primary Outcomes (2)

• 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

• radiological fusion of pars defect

  using CT scan for fusion percentage assess at 6 month of postoperation.

  6 month postoperative

Interventions

smiley face shape rod PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age above 18 years old
• Both sex
• failure of conservative treatment for 3months
• fit for surgery

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Standaert CJ, Herring SA. Spondylolysis: a critical review. Br J Sports Med. 2000 Dec;34(6):415-22. doi: 10.1136/bjsm.34.6.415.

  PMID: 11131228 BACKGROUND

• 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.

  PMID: 23737800 BACKGROUND

• 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. doi: 10.1302/0301-620x.85b2.13074.

  PMID: 12678361 BACKGROUND

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

  PMID: 3180570 BACKGROUND

• 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. doi: 10.1177/014107689108400509.

  PMID: 2041003 BACKGROUND

• 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. doi: 10.1016/s0030-5898(03)00034-8.

  PMID: 12974495 BACKGROUND

• 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.

  PMID: 23075858 BACKGROUND

• 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.

  PMID: 23691090 BACKGROUND

Central Study Contacts

Najib Al-shaea, MD

CONTACT

00201002784058; nageebalshaya@gmail.com

mohammed Taghyan

CONTACT

00201006876892; taghian@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator,assistant lecturer

Model Details: 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

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 22, 2020

Record last verified: 2020-09