Degenerative SpineMassoud-GoelNCT07001969
Percutaneous Trans-facet Spine Fixation
A study testing Massoud-Goel Technique and Theory and Percutaneous Trans-facet Fixation for Treatment of Degenerative Spine in people with Degenerative Spine and Degeneration of Lumbar Intervertebral Disc, run by Mahmoud Massoud at 1 site in Egypt.
Trial summary
Percutaneous Trans-facet Fixation Massoud-Goel Technique and Theory for Treatment of Degenerative Spine Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Spine, Degeneration of Lumbar Intervertebral Disc, Degenerative Cervical Disc Disease
- What is being tested?
- Massoud-Goel Technique and Theory and Percutaneous Trans-facet Fixation for Treatment of Degenerative Spine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jul 2024to 7 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cauda equine syndrome
- Progressive motor weakness
- Failed damage control method
- Spondylolisthesis, Spondyolysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Massoud-Goel Technique and Theory: Percutaneous Trans-facet Fixation for Treatment of Degenerative Spine
Percutaneous Trans-facet Fixation Massoud-Goel Technique and Theory for Treatment of Degenerative Spine
Read the 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.
- Conditions
- Degenerative Spine, Degeneration of Lumbar Intervertebral Disc, Degenerative Cervical Disc Disease, Ligamentum Flavum Hypertrophy, Spinal Canal Stenosis, Spine Instability
- Being tested
- Massoud-Goel Technique and Theory, Percutaneous Trans-facet Fixation for Treatment of Degenerative Spine
- Keywords
- Percutaneous, Trans-facet, Fixation, Massoud-Goel, Technique and Theory for Treatment of Degenerative Spine
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massoud-Goel Technique and TheoryProcedure or surgery
Percutaneous Trans-facet Fixation Massoud-Goel Technique and Theory for Treatment of Degenerative Spine
Percutaneous Trans-facet Fixation for Treatment of Degenerative SpineProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Massoud-Goel Technique and Theory; Procedure: Percutaneous Trans-facet Fixation for Treatment of Degenerative Spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Relief of pain from neuralgia (sciatica \& brachialgia) also claudication pain assessment by visual analogue scale 1-10
Measured: 3 months
Secondary outcomes (4)
Functional recovery
functional improvement postoperatively. Secondary outcomes include functional recovery (Oswestry Disability Index score)
Measured: 3 months
Less complications
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.
Measured: 1 year
Spinal stability
By CT spine we can assess facet fusion, stabilization of spine segmental instability
Measured: 6 months
Neurological decompression indirectly
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start7 Jul 2024
- Primary completion7 Feb 2025
- Study completion7 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Degenerative SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Massoud
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Military Academy for Medical Sciences
- Responsible party
- Sponsor-investigator, Mahmoud Massoud, Armed Forces College of Medicine, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001969
- Sponsor's protocol ID
- EGY-2025-PTFF-MGT-001
- Acronym
- Massoud-Goel
- Status last verified
- May 2025
- First submitted
- 13 Feb 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: New researches
Publications
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.
PubMed 15257485Magerl FP. Stabilization of the lower thoracic and lumbar spine with external skeletal fixation. Clin Orthop Relat Res. 1984 Oct;(189):125-41.
PubMed 6478690BOUCHER 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.
PubMed 13641310KING D. Internal fixation for lumbosacral fusion. J Bone Joint Surg Am. 1948 Jul;30A(3):560-5. No abstract available.
PubMed 18109577Goel 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.
PubMed 25013340Satoskar 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.
PubMed 25558146Goel 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.
PubMed 30783342
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massoud-Goel Technique and Theory: Percutaneous Trans-facet Fixation for Treatment of Degenerative Spine
- ClinicalTrials.gov ID
- NCT07001969
- Acronym / sponsor ID
- Massoud-Goel / EGY-2025-PTFF-MGT-001
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Mahmoud MassoudUniversity, hospital or other
- Collaborators
- Cairo University, Military Academy for Medical Sciences
- Study start
- 7 Jul 2024 (actual)
- Primary completion
- 7 Feb 2025 (actual)
- Study completion
- 7 Jul 2027 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Trans-Facet Fixation Using the Massoud-Goel Technique and Theory for Degenerative Spine | Experimental | Procedure: Massoud-Goel Technique and Theory, Procedure: Percutaneous Trans-facet Fixation for Treatment of Degenerative SpineThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Cauda equine syndrome
- Progressive motor weakness
- Failed damage control method
- Spondylolisthesis, Spondyolysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massoud-Goel Technique and TheoryPercutaneous Trans-facet Fixation Massoud-Goel Technique and Theory for Treatment of Degenerative Spine | Procedure or surgery | Percutaneous Trans-Facet Fixation Using the Massoud-Goel Technique and Theory for Degenerative Spine |
| Percutaneous Trans-facet Fixation for Treatment of Degenerative SpinePercutaneous 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 | Procedure or surgery | Percutaneous Trans-Facet Fixation Using the Massoud-Goel Technique and Theory for Degenerative Spine |
Primary outcome
Pain relief
Time frame: 3 months
Relief of pain from neuralgia (sciatica \& brachialgia) also claudication pain assessment by visual analogue scale 1-10
4 secondary outcomes
Functional recovery
Time frame: 3 months
Less complications
Time frame: 1 year
Spinal stability
Time frame: 6 months
Neurological decompression indirectly
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 15257485Borm 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.
- Background: PubMed 6478690Magerl FP. Stabilization of the lower thoracic and lumbar spine with external skeletal fixation. Clin Orthop Relat Res. 1984 Oct;(189):125-41.
- Background: PubMed 13641310BOUCHER 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.
- Background: PubMed 18109577KING D. Internal fixation for lumbosacral fusion. J Bone Joint Surg Am. 1948 Jul;30A(3):560-5. No abstract available.
- Background: PubMed 25013340Goel 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.
- Background: PubMed 25558146Satoskar 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.
- Background: PubMed 30783342Goel 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.
- Collection of auther about the theory and the techniqueLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. New researches
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massoud-Goel Technique and Theory and Percutaneous Trans-facet Fixation for Treatment of Degenerative Spine in people with Degenerative Spine and Degeneration of Lumbar Intervertebral Disc, run by Mahmoud Massoud at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07001969, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.