Percutaneous Trans-facet Spine Fixation

NCT07001969 | Enrolling By Invitation DMC

• 1 other identifier: EGY-2025-PTFF-MGT-001
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Percutaneous Trans-facet Fixation Massoud-Goel Technique and Theory for Treatment of Degenerative Spine

Conditions

Degenerative Spine; Degeneration of Lumbar Intervertebral Disc; Degenerative Cervical Disc Disease; Ligamentum Flavum Hypertrophy; Spinal Canal Stenosis; Spine Instability

Keywords

Percutaneous; Trans-facet; Fixation; Massoud-Goel; Technique and Theory for Treatment of Degenerative Spine

Outcome Measures

Primary Outcomes (1)

• Pain relief

  Relief of pain from neuralgia (sciatica \& brachialgia) also claudication pain assessment by visual analogue scale 1-10

  3 months

Secondary Outcomes (4)

• Functional recovery

  3 months

• Less complications

  1 year

• Spinal stability

  6 months

• Neurological decompression indirectly

  6 months

Study Arms (1)

Percutaneous Trans-Facet Fixation Using the Massoud-Goel Technique and Theory for Degenerative Spine

EXPERIMENTAL

This study arm involves the use of Percutaneous Trans-Facet Fixation (PTFF) with the Massoud-Goel Technique and Theory (MGT) for the treatment of degenerative spine conditions, Looking for signs of instability. In this arm will undergo minimally invasive trans-facet screw fixation to provide spinal stability while preserving mobility and reducing soft tissue disruption. The intervention includes: * Preoperative Assessment: MRI and CT scans to evaluate facet joint degeneration and spinal instability. * Surgical Technique: Percutaneous placement of facet screws under fluoroscopic guidance, following the principles of the Massoud-Goel Technique. * Postoperative Care: Patients will follow a structured rehabilitation program, including pain management and physiotherapy, to assess functional recovery and long-term outcomes. The study aims to evaluate radiological fusion rates, pain relief (VAS scores), functional improvement (ODI scores), and complication rates associations.

Procedure: Massoud-Goel Technique and Theory; Procedure: Percutaneous Trans-facet Fixation for Treatment of Degenerative Spine

Interventions

Massoud-Goel Technique and Theory PROCEDURE

Percutaneous Trans-facet Fixation Massoud-Goel Technique and Theory for Treatment of Degenerative Spine

Percutaneous Trans-Facet Fixation Using the Massoud-Goel Technique and Theory for Degenerative Spine

Percutaneous Trans-facet Fixation for Treatment of Degenerative Spine PROCEDURE

Percutaneous Trans-facet Fixation (Developmental of Dr Atul goel technique of transfacet fixation by open surgery using Magrel technique) Massoud-Goel Technique and Theory for Treatment of Degenerative Spine

Percutaneous Trans-Facet Fixation Using the Massoud-Goel Technique and Theory for Degenerative Spine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For Lumbar Sub-axial cervical instability Clinical radicular symptoms can indicate the level of spinal instability. The presence of osteophytes. Reduction of the intervertebral disc space. Disc prolapse. Ligamentum flavum buckling. For atlantoaxial instability Cervical myelopathy clinical Alteration of atlantodental interval on dynamic flexion-extension images.

You may not qualify if:

• Cauda equine syndrome
• Progressive motor weakness
• Failed damage control method
• Spondylolisthesis, Spondyolysis.

Sponsors & Collaborators

• Mahmoud Massoud: lead
• Cairo University: collaborator
• Military Academy for Medical Sciences: collaborator

Study Sites (1)

434

Cairo, Shorouk, 41639, Egypt

Location

Related Publications (7)

• Borm W, Konig RW, Albrecht A, Richter HP, Kast E. Percutaneous transarticular atlantoaxial screw fixation using a cannulated screw system and image guidance. Minim Invasive Neurosurg. 2004 Apr;47(2):111-4. doi: 10.1055/s-2004-818449.

  PMID: 15257485 BACKGROUND

• Magerl FP. Stabilization of the lower thoracic and lumbar spine with external skeletal fixation. Clin Orthop Relat Res. 1984 Oct;(189):125-41.

  PMID: 6478690 BACKGROUND

• BOUCHER HH. A method of spinal fusion. J Bone Joint Surg Br. 1959 May;41-B(2):248-59. doi: 10.1302/0301-620X.41B2.248. No abstract available.

  PMID: 13641310 BACKGROUND

• KING D. Internal fixation for lumbosacral fusion. J Bone Joint Surg Am. 1948 Jul;30A(3):560-5. No abstract available.

  PMID: 18109577 BACKGROUND

• Goel A. Goel's classification of atlantoaxial "facetal" dislocation. J Craniovertebr Junction Spine. 2014 Jan;5(1):3-8. doi: 10.4103/0974-8237.135206. No abstract available.

  PMID: 25013340 BACKGROUND

• Satoskar SR, Goel AA, Mehta PH, Goel A. Quantitative morphometric analysis of the lumbar vertebral facets and evaluation of feasibility of lumbar spinal nerve root and spinal canal decompression using the Goel intraarticular facetal spacer distraction technique: A lumbar/cervical facet comparison. J Craniovertebr Junction Spine. 2014 Oct;5(4):157-62. doi: 10.4103/0974-8237.147079.

  PMID: 25558146 BACKGROUND

• Goel A. From "only decompression" to "only fixation:" A century-long journey of surgical treatment for spinal spondylosis. J Craniovertebr Junction Spine. 2018 Oct-Dec;9(4):219-220. doi: 10.4103/jcvjs.JCVJS_118_18. No abstract available.

  PMID: 30783342 BACKGROUND

Related Links

• Collection of auther about the theory and the technique

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer Orthopedic surgery department Orthopedic Surgery AFCM Cairo Egypt, Consultant spine surgery Helmya Military hospital, Spine unit.

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: June 3, 2025
• Study Start: July 7, 2024
• Primary Completion: February 7, 2025
• Study Completion (Estimated): July 7, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 7 years
• Access Criteria: IPD Sharing Access Criteria for the Study:\*\* \*\*"Percutaneous Trans-Facet Fixation Using the Massoud-Goel Technique for Treatment of Degenerative Spine" 1. Data Availability: * De-identified Individual Participant Data (IPD) will be made available for academic and research purposes. * Shared data will include patient demographics, radiographic outcomes, clinical assessments (VAS, ODI scores), and surgical parameters\*\*. 2. Access Requirements: * Researchers must submit a formal request with a brief research proposal outlining the intended use of the data. * Approval from an \*\*Institutional Review Board (IRB) or Ethics Committee is mandatory. * A Data Use Agreement (DUA) must be signed to ensure compliance with ethical and legal regulations. 3. Timing of Data Sharing: * Data will be available 6 months after the primary publication of study results. * The sharing period will extend for 5 years post-publ

Locations

EG (1)