Percutaneous Trans-facet Spine Fixation

Not Applicable

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

• Registration Number: NCT07001969
• Lead Sponsor: Mahmoud Massoud

Brief Summary

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

Detailed Description

Massoud-Goel' as rationale treatment for treatment spinal degeneration affected spinal segments using trans-articular screws, without physically distracting the facets, or removal of any part of the bone or ligament.

Following fixing of the segment, all the secondary phenomenon reverse, effectively increasing the canal size and reversing the effects of spinal degeneration and spinal canal stenosis.

Stabilizes the region and provides an environment for resorption of the herniated disc and ultimate arthrodesis of the spinal segments.

Study Timeline

• Study Start: 2024-07-07
• Primary Completion: 2025-02-07
• Study First Submitted: 2025-02-13
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-24
• Last Update Submitted: 2025-05-24
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03
• Study Completion: 2027-07-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

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.

Exclusion Criteria

1. Cauda equine syndrome
2. Progressive motor weakness
3. Failed damage control method
4. Spondylolisthesis, Spondyolysis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain relief	3 months	Relief of pain from neuralgia (sciatica \& brachialgia) also claudication pain assessment by visual analogue scale 1-10

Secondary Outcome Measures

Name	Time	Method
Functional recovery	3 months	functional improvement postoperatively. Secondary outcomes include functional recovery (Oswestry Disability Index score)
Less complications	1 year	fusion rates (CT scan), and complication rates, assessing both efficacy and safety.; Additional measures like hospital stay duration and patient satisfaction provide insights into procedural efficiency and patient-reported outcomes.
Spinal stability	6 months	By CT spine we can assess facet fusion, stabilization of spine segmental instability
Neurological decompression indirectly	6 months	Early by position of patients intraoperative and stabilization, late by healing of pathological state of ligament flavum hypertrophic changes, disc degeneration, spinal canal stenosis by Magnetic resonance imaging follow-up

Trial Locations

Locations (1)

434; 🇪🇬 Cairo, Shorouk, Egypt