Cervical Spine FracturesMALMOSNCT07905573
MALMOS Technique for Selected Subaxial Cervical Spine Fractures
A study testing Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS) Technique With Neutralization H-Plate Fixation in people with Cervical Spine Fractures, run by Assiut University at 1 site in Egypt.
Trial summary
This prospective study will evaluate the clinical and radiological outcomes of the MALMOS technique with neutralization H-plate fixation in patients with selected subaxial cervical spine fractures. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cervical Spine Fractures
- What is being tested?
- Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS) Technique With Neutralization H-Plate Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 30 Sep 2028
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 years or older.
- Acute subaxial cervical spine fracture involving C3 to C7.
- AO Spine type A3 or A4 fracture.
- Presentation within 2 weeks of injury.
- One or more eligible fracture levels.
- Any neurological status.
Who cannot join
- Pathological or osteoporotic fracture.
- Previous major cervical spine surgery at the affected level.
- Failure to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University Trauma Hospital
Asyut, Asyut Governorate
Mina Safwat Fekry, Assistant Lecturer, +201280880281, MinaS.Fekry@aun.edu.eg
Mohamed A El-Meshtawy, MD, mohamedel-meshtawy@aun.edu.eg
About this study
Official title: Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS) With Neutralization H-Plate Fixation for Selected Subaxial Cervical Spine Fractures: Description of a New Surgical Technique and Case Series
This prospective study will evaluate the clinical and radiological outcomes of the MALMOS technique with neutralization H-plate fixation in patients with selected subaxial cervical spine fractures. The study will assess fracture healing, maintenance of cervical alignment, functional and neurological outcomes, complications, and the need for additional surgery during follow-up
Read the detailed description
Trauma to the cervical spine is a common cause of spinal cord injury. Subaxial cervical spine trauma refers to injuries involving the C3 to C7 levels, with a substantial proportion occurring in the lower cervical spine.
The AO Spine Subaxial Cervical Spine Injury Classification System provides a standardized framework for describing these injuries according to fracture morphology, facet injury, neurological status, and clinical modifiers. Type A injuries represent compression injuries with an intact tension band. Type A3 fractures are burst injuries involving one endplate and the posterior vertebral body wall, whereas type A4 fractures involve both endplates and may be associated with more extensive vertebral body disruption. These injuries, particularly more extensive A4 fractures, may result in loss of vertebral body height and secondary kyphotic deformity, making restoration and maintenance of sagittal alignment important treatment considerations.
In selected severely comminuted subaxial cervical burst fractures, anterior corpectomy with anterior column reconstruction may be considered, particularly when direct decompression or removal of an unsalvageable vertebral body is required. However, corpectomy involves removal of the native vertebral body and subsequent anterior column reconstruction.
Prof. Mohamed El-Meshtawy of Egypt described the concept of anterior ligamentotaxis combined with direct reduction and osteosynthesis of selected A3 and A4 subaxial cervical fractures. The technique, termed Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS), is designed to facilitate reduction and fixation of the fractured vertebral body itself, with the aim of preserving the native vertebral body and potentially preserving segmental motion following fracture healing and subsequent implant removal when clinically appropriate.
This prospective case series will systematically evaluate the clinical and radiological outcomes of MALMOS with neutralization H-plate fixation in selected subaxial cervical spine fractures. The study will assess maintenance of sagittal alignment, fracture healing, vertebral body height, pain, functional and neurological outcomes, complications, implant-related outcomes, and the need for secondary surgery during follow-up.
- Conditions
- Cervical Spine Fractures
- Being tested
- Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS) Technique With Neutralization H-Plate Fixation
- Keywords
- MALMOS, Subaxial cervical spine fractures, Anterior cervical fixation, AO Spine type A3, AO Spine type A4, miniplate osteosynthesis, ligamentotaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS) Technique With Neutralization H-Plate FixationProcedure or surgery
A surgical technique described by Prof. Mohamed El-Meshtawy in Assiut, Egypt, for the treatment of selected subaxial cervical spine fractures, involving anterior ligamentotaxis and miniplate osteosynthesis with neutralization H-plate fixation.
| Study group | Role | What they receive |
|---|---|---|
| MALMOS Treatment | Experimental | Participants will undergo surgical treatment using Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS) technique with neutralization H-plate fixation for selected subaxial cervical spine fractures. Receives: Procedure: Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS) Technique With Neutralization H-Plate Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segmental Cobb Angle (Degrees)
Change in segmental Cobb angle from the immediate postoperative measurement to the final assessment at CT-confirmed fracture healing.
Measured: Preoperatively, immediately postoperatively, and through 6 months postoperatively or until CT-confirmed fracture healing, whichever occurs first.
Secondary outcomes (6)
Vertebral Body Height (precentage)
Change in anterior and posterior vertebral body height from the immediate postoperative assessment to the final radiological assessment.
Measured: Preoperatively, immediately postoperatively, and through 6 months postoperatively or until CT-confirmed fracture healing, whichever occurs first.
Pain Intensity (Visual Analog Scale Score)
Visual Analog Scale for Neck Pain (VAS): Scores range from 0 to 10, with higher scores indicating greater pain and a worse outcome.
Measured: through study completion, an average of 6 months
Neck Disability
Neck Disability Index (NDI): Total scores range from 0 to 50, with higher scores indicating greater neck-related disability and a worse outcome.
Measured: through study completion, an average of 6 months
Neurological Status
American Spinal Injury Association (ASIA) Impairment Scale (AIS): Grades range from A to E, with Grade A indicating a complete spinal cord injury and Grade E indicating normal sensory and motor function. Higher grades indicate better neurological function and a better outcome.
Measured: through study completion, an average of 6 months
Complications
Incidence of perioperative and postoperative complications
Measured: through study completion, an average of 6 months
Secondary Surgery
Incidence of Secondary Surgery
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Sep 2028 (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 Cervical Spine FracturesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina S. Fekry, Assiut University
- Investigators
- Mohamed A El-Meshtawy, MD, Study chair, Assiut University, EgyptAli M Khalil, MD, Study director, Assiut University, EgyptEssam M El-Morshedi, MD, Study director, Assiut University, EgyptMina Safwat Fekry, MSc, Principal investigator, Assiut University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905573
- Sponsor's protocol ID
- AUN-MALMOS-2026
- Acronym
- MALMOS
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because of participant privacy and confidentiality considerations.
Publications
Sharif S, Ali MYJ, Sih IMY, Parthiban J, Alves OL. Subaxial Cervical Spine Injuries: WFNS Spine Committee Recommendations. Neurospine. 2020 Dec;17(4):737-758. doi: 10.14245/ns.2040368.184. Epub 2020 Dec 31.
PubMed 33401854Schleicher P, Kobbe P, Kandziora F, Scholz M, Badke A, Brakopp F, Ekkerlein H, Gercek E, Hartensuer R, Hartung P, Jarvers JS, Matschke S, Morrison R, Muller CW, Pishnamaz M, Reinhold M, Schmeiser G, Schnake KJ, Stein G, Ullrich B, Weiss T, Zimmermann V. Treatment of Injuries to the Subaxial Cervical Spine: Recommendations of the Spine Section of the German Society for Orthopaedics and Trauma (DGOU). Global Spine J. 2018 Sep;8(2 Suppl):25S-33S. doi: 10.1177/2192568217745062. Epub 2018 Sep 7.
PubMed 30210958Madan A, Thakur M, Sud S, Jain V, Singh Thakur RP, Negi V. Subaxial Cervical Spine Injuries: Outcomes after Anterior Corpectomy and Instrumentation. Asian J Neurosurg. 2019 Jul-Sep;14(3):843-847. doi: 10.4103/ajns.AJNS_331_17.
PubMed 31497112Aebi M. Surgical treatment of upper, middle and lower cervical injuries and non-unions by anterior procedures. Eur Spine J. 2010 Mar;19 Suppl 1(Suppl 1):S33-9. doi: 10.1007/s00586-009-1120-8. Epub 2009 Oct 14.
PubMed 19826842Foreman M, Foster D, Gillam W, Ciesla C, Lamprecht C, Lucke-Wold B. Management Considerations for Cervical Corpectomy: Updated Indications and Future Directions. Life (Basel). 2024 May 21;14(6):651. doi: 10.3390/life14060651.
PubMed 38929635Bono CM, Vaccaro AR, Fehlings M, Fisher C, Dvorak M, Ludwig S, Harrop J. Measurement techniques for lower cervical spine injuries: consensus statement of the Spine Trauma Study Group. Spine (Phila Pa 1976). 2006 Mar 1;31(5):603-9. doi: 10.1097/01.brs.0000201273.39058.dd.
PubMed 16508560Vaccaro AR, Koerner JD, Radcliff KE, Oner FC, Reinhold M, Schnake KJ, Kandziora F, Fehlings MG, Dvorak MF, Aarabi B, Rajasekaran S, Schroeder GD, Kepler CK, Vialle LR. AOSpine subaxial cervical spine injury classification system. Eur Spine J. 2016 Jul;25(7):2173-84. doi: 10.1007/s00586-015-3831-3. Epub 2015 Feb 26.
PubMed 25716661
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS) With Neutralization H-Plate Fixation for Selected Subaxial Cervical Spine Fractures: Description of a New Surgical Technique and Case Series
- ClinicalTrials.gov ID
- NCT07905573
- Acronym / sponsor ID
- MALMOS / AUN-MALMOS-2026
- Conditions
- Cervical Spine Fractures
- Keywords
- MALMOS, Subaxial cervical spine fractures, Anterior cervical fixation, AO Spine type A3, AO Spine type A4, miniplate osteosynthesis, ligamentotaxis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 29 Oct 2026 (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.
This prospective study will evaluate the clinical and radiological outcomes of the MALMOS technique with neutralization H-plate fixation in patients with selected subaxial cervical spine fractures. The study will assess fracture healing, maintenance of cervical alignment, functional and neurological outcomes, complications, and the need for additional surgery during follow-up
Detailed description
Trauma to the cervical spine is a common cause of spinal cord injury. Subaxial cervical spine trauma refers to injuries involving the C3 to C7 levels, with a substantial proportion occurring in the lower cervical spine.
The AO Spine Subaxial Cervical Spine Injury Classification System provides a standardized framework for describing these injuries according to fracture morphology, facet injury, neurological status, and clinical modifiers. Type A injuries represent compression injuries with an intact tension band. Type A3 fractures are burst injuries involving one endplate and the posterior vertebral body wall, whereas type A4 fractures involve both endplates and may be associated with more extensive vertebral body disruption. These injuries, particularly more extensive A4 fractures, may result in loss of vertebral body height and secondary kyphotic deformity, making restoration and maintenance of sagittal alignment important treatment considerations.
In selected severely comminuted subaxial cervical burst fractures, anterior corpectomy with anterior column reconstruction may be considered, particularly when direct decompression or removal of an unsalvageable vertebral body is required. However, corpectomy involves removal of the native vertebral body and subsequent anterior column reconstruction.
Prof. Mohamed El-Meshtawy of Egypt described the concept of anterior ligamentotaxis combined with direct reduction and osteosynthesis of selected A3 and A4 subaxial cervical fractures. The technique, termed Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS), is designed to facilitate reduction and fixation of the fractured vertebral body itself, with the aim of preserving the native vertebral body and potentially preserving segmental motion following fracture healing and subsequent implant removal when clinically appropriate.
This prospective case series will systematically evaluate the clinical and radiological outcomes of MALMOS with neutralization H-plate fixation in selected subaxial cervical spine fractures. The study will assess maintenance of sagittal alignment, fracture healing, vertebral body height, pain, functional and neurological outcomes, complications, implant-related outcomes, and the need for secondary surgery during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MALMOS Treatment | Experimental | Procedure: Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS) Technique With Neutralization H-Plate FixationParticipants will undergo surgical treatment using Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS) technique with neutralization H-plate fixation for selected subaxial cervical spine fractures. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 12 years or older.
- Acute subaxial cervical spine fracture involving C3 to C7.
- AO Spine type A3 or A4 fracture.
- Presentation within 2 weeks of injury.
- One or more eligible fracture levels.
Key exclusion criteria (3 listed)
- Pathological or osteoporotic fracture.
- Previous major cervical spine surgery at the affected level.
- Failure to provide informed consent.
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 |
|---|---|---|
| Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS) Technique With Neutralization H-Plate FixationA surgical technique described by Prof. Mohamed El-Meshtawy in Assiut, Egypt, for the treatment of selected subaxial cervical spine fractures, involving anterior ligamentotaxis and miniplate osteosynthesis with neutralization H-plate fixation. | Procedure or surgery | MALMOS Treatment |
Primary outcome
Segmental Cobb Angle (Degrees)
Time frame: Preoperatively, immediately postoperatively, and through 6 months postoperatively or until CT-confirmed fracture healing, whichever occurs first.
Change in segmental Cobb angle from the immediate postoperative measurement to the final assessment at CT-confirmed fracture healing.
6 secondary outcomes
Vertebral Body Height (precentage)
Time frame: Preoperatively, immediately postoperatively, and through 6 months postoperatively or until CT-confirmed fracture healing, whichever occurs first.
Pain Intensity (Visual Analog Scale Score)
Time frame: through study completion, an average of 6 months
Neck Disability
Time frame: through study completion, an average of 6 months
Neurological Status
Time frame: through study completion, an average of 6 months
Complications
Time frame: through study completion, an average of 6 months
Secondary Surgery
Time frame: through study completion, an average of 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 29 Oct 2026.
- Background: PubMed 33401854Sharif S, Ali MYJ, Sih IMY, Parthiban J, Alves OL. Subaxial Cervical Spine Injuries: WFNS Spine Committee Recommendations. Neurospine. 2020 Dec;17(4):737-758. doi: 10.14245/ns.2040368.184. Epub 2020 Dec 31.
- Background: PubMed 30210958Schleicher P, Kobbe P, Kandziora F, Scholz M, Badke A, Brakopp F, Ekkerlein H, Gercek E, Hartensuer R, Hartung P, Jarvers JS, Matschke S, Morrison R, Muller CW, Pishnamaz M, Reinhold M, Schmeiser G, Schnake KJ, Stein G, Ullrich B, Weiss T, Zimmermann V. Treatment of Injuries to the Subaxial Cervical Spine: Recommendations of the Spine Section of the German Society for Orthopaedics and Trauma (DGOU). Global Spine J. 2018 Sep;8(2 Suppl):25S-33S. doi: 10.1177/2192568217745062. Epub 2018 Sep 7.
- Background: PubMed 31497112Madan A, Thakur M, Sud S, Jain V, Singh Thakur RP, Negi V. Subaxial Cervical Spine Injuries: Outcomes after Anterior Corpectomy and Instrumentation. Asian J Neurosurg. 2019 Jul-Sep;14(3):843-847. doi: 10.4103/ajns.AJNS_331_17.
- Background: PubMed 19826842Aebi M. Surgical treatment of upper, middle and lower cervical injuries and non-unions by anterior procedures. Eur Spine J. 2010 Mar;19 Suppl 1(Suppl 1):S33-9. doi: 10.1007/s00586-009-1120-8. Epub 2009 Oct 14.
- Background: PubMed 38929635Foreman M, Foster D, Gillam W, Ciesla C, Lamprecht C, Lucke-Wold B. Management Considerations for Cervical Corpectomy: Updated Indications and Future Directions. Life (Basel). 2024 May 21;14(6):651. doi: 10.3390/life14060651.
- Background: PubMed 16508560Bono CM, Vaccaro AR, Fehlings M, Fisher C, Dvorak M, Ludwig S, Harrop J. Measurement techniques for lower cervical spine injuries: consensus statement of the Spine Trauma Study Group. Spine (Phila Pa 1976). 2006 Mar 1;31(5):603-9. doi: 10.1097/01.brs.0000201273.39058.dd.
- Background: PubMed 25716661Vaccaro AR, Koerner JD, Radcliff KE, Oner FC, Reinhold M, Schnake KJ, Kandziora F, Fehlings MG, Dvorak MF, Aarabi B, Rajasekaran S, Schroeder GD, Kepler CK, Vialle LR. AOSpine subaxial cervical spine injury classification system. Eur Spine J. 2016 Jul;25(7):2173-84. doi: 10.1007/s00586-015-3831-3. Epub 2015 Feb 26.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers because of participant privacy and confidentiality considerations.
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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.
Mohamed A El-Meshtawy, MD study chair
Assiut University, Egypt
Ali M Khalil, MD study director
Assiut University, Egypt
Essam M El-Morshedi, MD study director
Assiut University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meshtawy's Anterior Ligamentotaxis and Miniplate Osteosynthesis (MALMOS) Technique With Neutralization H-Plate Fixation in people with Cervical Spine Fractures, run by Assiut University 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 Oct 2026. 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?
Contact Mina Safwat Fekry, Assistant Lecturer (01280880281, MinaS.Fekry@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Segmental Cobb Angle (Degrees) (time frame: Preoperatively, immediately postoperatively, and through 6 months postoperatively or until CT-confirmed fracture healing, whichever occurs first.). 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 NCT07905573, 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 29 Oct 2026.