Cervical Instabilities SpineNCT03250611
Occipito-Cervical Stabilization Using Occipital Condyle Screw
A study testing Occipital Condyle Screw in people with Cervical Instabilities Spine, run by Assiut University.
Trial summary
The Occipito-Cervical (OC) junction is the most cephalad portion of the spinal axis, with anatomical osseous complex that allows significant mobility while maintaining biomechanical stability. OC instability is a rare disorder with potentially life-threatening consequences. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cervical Instabilities Spine
- What is being tested?
- Occipital Condyle Screw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with occipito-cervical instability of any cause, indicated for occipito-cervical fusion
Who cannot join
- Fractured occipital condyle
- Congenital malformation of occipital condyle
- Congenital anomaly of the horizontal segment of the vertebral artery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Occipito-Cervical Stabilization Using Occipital Condyle as a Cranial Anchor
The Occipito-Cervical (OC) junction is the most cephalad portion of the spinal axis, with anatomical osseous complex that allows significant mobility while maintaining biomechanical stability. OC instability is a rare disorder with potentially life-threatening consequences. Instability may manifest as disabling pain, cranial nerve dysfunction, paralysis, or even sudden death. The most common acute presentation is secondary to major trauma. Other pathologic processes that may lead to chronic instability include rheumatoid arthritis, infections, tumors, and even congenital malformations; OC fusion in aforementioned cases each according is then indicated.
Stabilization of the OC junction remains a challenge, owing to the regional anatomy and poor occipital bone purchase. OC stabilization techniques have undergone continuous refinement. Early techniques involving simple posterior only bone grafts demonstrated a high rate of failure and have largely been replaced by rigid posterior fixation systems using rods/screws or plates, providing superior biomechanical stability and higher rates of fusion. One of the very modern modalities of fixation methods is the Occipital Condyle Screw (OCS) as a sole cranial anchor; believing that decreasing the length of lever arm of the construct, increasing the length of the screw purchase, and decreasing stresses addressed on the rod with no need to excessively bend it for the occipital slope may enhance the construct rigidity, and leaving a greater clear metal-free area of the occiput for graft contact may have a real potential benefits in fusion rates.
Read the detailed description
Clinical Evaluation: of patients with 1- Visual Analogue Scale (VAS), 2- Neck Disability Index (NDI), 3- Modified Japanese Orthopaedic Association Cervical Myelopathy Score (mJOA.CMS), 4- American Spinal Injury Association Score (ASIAs). Immediate preoperative functional scoring, and 6 weeks, 3 months, 6 months, and 1 year postoperative.
Surgical Technique: The patient is handled in prone position after successful general anaesthesia with supported head to ensure that the Occipito-Cervical junction maintains in neutral position. The Occipito-Cervical junction is then exposed through a traditional midline longitudinal posterior skin incision extends from the external occipital protuberance to the C3-C4 level. The nuchal ligament is divided in the midline, and the occipital and cervical musculature is dissected subperiosteally. The suboccipital and cervical paraspinous muscles are retracted laterally to expose the underlying bony architecture. The posterior arch of C1 is exposed and the dissection is continued laterally in a subperiosteal manner to identify the horizontal segment of the vertebral arteries (VAs) which is enveloped in a dense venous plexus. The atlanto-occipital joint capsule is to be approx. 3 mm. Cranial to the superior margin of tht VA. Attention is then focused on the foramen magnum. Using curettes, the atlanto-occipital membrane is gently dissected from the foramen magnum laterally until the medial aspect of the occipital condyle is reached. At this point, the dissection continues laterally, maintaining bone contact to prevent injury to the horizontal segment of the VA along the condylar fossa, until the posterior condylar foramen and emissary vein are identified. The condylar foramen and vein represent the lateral extent of the dissection. At this stage, the operative field is prepared for instrumentation. Inserting the cervical screws first provides useful information about the axial location of the occipital condyles. The condylar entry point (CEP) is defined using a combination of radiographic and anatomic landmarks. The CEP is located (4 to 5 mm) lateral to the posteromedial edge of the condyle, and (2 mm) above the atlanto-occipital joint line. Pilot hole is then made at the entry point using an awl with slight cranial angulation to avoid injury to the horizontal segment of the VA. The pilot hole is then drilled under image-guidance in a convergent trajectory with (12 to 22 degrees) of medial angulation and (5 degrees) cranial angulation in the sagittal plane with the tip of the drill directed toward the basion, advancing slowly until the anterior cortical edge of the condyle is breached. The hole is tapped, and a (3.5 mm) polyaxial screw of an appropriate length (30 to 34 mm) is inserted bicortically into the occipital condyle. Approximately (12 mm) portion of the screw remains superficial to the posterior cortex of the condyle, allowing the polyaxial portion of the screw to lie above the posterior arch of C1, minimizing any chance of irritation of the VA by the rods.
Radiological Evaluation: 1- Preoperative: Plain X-ray (PXR) Antero-posterior (AP) and Lateral (Lat.) views to study the upper cervical instability indices and measurements, Multi-Slice Computed Tomography (MSCT) to study the boney Occipito-Cervical architecture for any fractures or anomalies, CT Angiography (CTA) to study the vertebral artery for anomaly especially in the horizontal segment of the VA, and Magnetic Resonance Imaging (MRI) to study the spinal cord for any compression signs. 2- Postoperative: Immediate (PXR) AP. and Lat. views for overall global assessment of the reduction and the construct installation. Then at 3 months, 6 months, and 1 year after surgery with flexion extension lateral view bending stress films for assessment of stability. Immediate (MSCT) to study the crucial screws placement estate for any breaches or successfulness, and after 1year for assessment of the fusion rate achieved.
Serial Follow-Up: after 6 weeks for clinical evaluation and functional scoring. At 3 and 6 months for radiological evaluation of stability, clinical evaluation and functional re-scoring. At 1 year for evaluation of fusion rate, clinical evaluation and over all resultant functional scores.
- Conditions
- Cervical Instabilities Spine
- Being tested
- Occipital Condyle Screw
- Keywords
- Occipital condyle, Occipital condyle screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occipital Condyle ScrewProcedure or surgery
Occipito-Cervical Screw-Rod Fixation Technique
| Study group | Role | What they receive |
|---|---|---|
| Occipito-Cervical Instability | Experimental | Stabilization of the occipito-cervical junction by Occipital Condyle Screw (OCS) as a sole cranial anchor, with posterior bone graft. Receives: Procedure: Occipital Condyle Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT based classification for assessment of biological graft fusion
A new assessment method of bony union using high-speed spiral CT imaging is proposed which reflects the gradually increasing biological stability of the construct. Grade I (complete fusion) implies cortical union of the allograft and central trabecular continuity. Grade II (partial fusion) implies cortical union of the structural allograft with partial trabecular incorporation. Grade III (unipolar pseudarthrosis) denotes superior or inferior cortical non-union of the central allograft with partial trabecular discontinuity centrally and Grade IV (bipolar pseudarthrosis) suggests both superior and inferior cortical non-union with a complete lack of central trabecular continuity.
Measured: At 6 months postoperative
Secondary outcomes (4)
Visual Analogue Scale for Pain (VAS Pain)
Operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
Measured: Baseline measure, then at 2 weeks, 3 months and 6 months postoperative
Neck Disability Index (NDI)
Each of 10 items, which are 1. Pain intensity 2. Personal care 3. Lifting 4. Reading 5. Headaches 6. Concentration 7. Work 8. Driving 9. Sleeping 10. Recreation, is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. Occasionally, a respondent will not complete one question or another. The average of all other items is then added to the completed items.
The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability, 5 - 14 = mild, 15 - 24 = moderate, 25 - 34 = severe, and above 34 = complete.
Measured: Baseline measure, then at 2 weeks, 3 months and 6 months postoperative
American Spinal Injury Association Score (ASIAs)
A score developed by the American Spinal Injury Association for essential minimal elements of neurologic assessment for all patients with a spinal injury.
(A). Complete loss of motor and sensory function below the level of injury, including the anal saddle shaped area.
(B). Spared all/some sensory function below the level of injury, including the anal saddle shaped area.
(C). Spared all/some motor function below the level of injury, but cannot move against gravity.
(D). Spared all/some motor function below the level of injury, with ability to move against gravity.
(E). Neurologically free.
Measured: Baseline and 3 months postoperative
Modified Japanese Orthopaedic Association Cervical Spondylotic Myelopathy Score (mJOA.CSM)
Motor dysfunction Upper extremities
- Doesn't move hands
- Doesn't eat with a spoon, moves hands
- Doesn't button shirt, eats with a spoon
- Buttons shirt with great difficulty
- Buttons shirt with slight difficulty
- No dysfunction
Motor dysfunction Lower extremities
- Complete loss motor \& sensory
- Sensory preservation, doesn't move legs
- Moves legs, doesn't walk
- Walks on flat floor with walking aid
- Walks up or downstairs w/aid of a handrail
- Moderate-to-significant lack of stability, walks up or downstairs without handrail
- Mild lack of stability, walks unaided with smooth reciprocation
- No dysfunction
Sensory dysfunction Upper extremities
- Complete loss of hand sensation
- Severe sensory loss or pain
- Mild sensory loss
- No sensory loss
Sphincter dysfunction
- Unable to micturate voluntarily
- Marked difficulty in micturition
- Mild-to-moderate difficulty in micturition
- Normal micturition
Measured: Baseline and 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study startSep 2017 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cervical Instabilities SpineStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Almessry, Assiut University
- Investigators
- Mohamed El-Meshtawy, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250611
- Sponsor's protocol ID
- OC.Screw
- Status last verified
- Aug 2017
- First submitted
- 10 Aug 2017
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uribe JS, Ramos E, Vale F. Feasibility of occipital condyle screw placement for occipitocervical fixation: a cadaveric study and description of a novel technique. J Spinal Disord Tech. 2008 Dec;21(8):540-6. doi: 10.1097/BSD.0b013e31816d655e.
PubMed 19057245Uribe JS, Ramos E, Youssef AS, Levine N, Turner AW, Johnson WM, Vale FL. Craniocervical fixation with occipital condyle screws: biomechanical analysis of a novel technique. Spine (Phila Pa 1976). 2010 Apr 20;35(9):931-8. doi: 10.1097/BRS.0b013e3181c16f9a.
PubMed 20375778Uribe JS, Ramos E, Baaj A, Youssef AS, Vale FL. Occipital cervical stabilization using occipital condyles for cranial fixation: technical case report. Neurosurgery. 2009 Dec;65(6):E1216-7; discussion E1217. doi: 10.1227/01.NEU.0000349207.98394.FA.
PubMed 19934947La Marca F, Zubay G, Morrison T, Karahalios D. Cadaveric study for placement of occipital condyle screws: technique and effects on surrounding anatomic structures. J Neurosurg Spine. 2008 Oct;9(4):347-53. doi: 10.3171/SPI.2008.9.10.347.
PubMed 18939920Ahmadian A, Dakwar E, Vale FL, Uribe JS. Occipitocervical fusion via occipital condylar fixation: a clinical case series. J Spinal Disord Tech. 2014 Jun;27(4):232-6. doi: 10.1097/BSD.0b013e31825bfeea.
PubMed 24866907Tan GH, Goss BG, Thorpe PJ, Williams RP. CT-based classification of long spinal allograft fusion. Eur Spine J. 2007 Nov;16(11):1875-81. doi: 10.1007/s00586-007-0376-0. Epub 2007 May 12.
PubMed 17497188
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occipito-Cervical Stabilization Using Occipital Condyle as a Cranial Anchor
- ClinicalTrials.gov ID
- NCT03250611
- Acronym / sponsor ID
- OC.Screw
- Conditions
- Cervical Instabilities Spine
- Keywords
- Occipital condyle, Occipital condyle screw
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 15 Aug 2017 (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.
The Occipito-Cervical (OC) junction is the most cephalad portion of the spinal axis, with anatomical osseous complex that allows significant mobility while maintaining biomechanical stability. OC instability is a rare disorder with potentially life-threatening consequences. Instability may manifest as disabling pain, cranial nerve dysfunction, paralysis, or even sudden death. The most common acute presentation is secondary to major trauma. Other pathologic processes that may lead to chronic instability include rheumatoid arthritis, infections, tumors, and even congenital malformations; OC fusion in aforementioned cases each according is then indicated.
Stabilization of the OC junction remains a challenge, owing to the regional anatomy and poor occipital bone purchase. OC stabilization techniques have undergone continuous refinement. Early techniques involving simple posterior only bone grafts demonstrated a high rate of failure and have largely been replaced by rigid posterior fixation systems using rods/screws or plates, providing superior biomechanical stability and higher rates of fusion. One of the very modern modalities of fixation methods is the Occipital Condyle Screw (OCS) as a sole cranial anchor; believing that decreasing the length of lever arm of the construct, increasing the length of the screw purchase, and decreasing stresses addressed on the rod with no need to excessively bend it for the occipital slope may enhance the construct rigidity, and leaving a greater clear metal-free area of the occiput for graft contact may have a real potential benefits in fusion rates.
Detailed description
Clinical Evaluation: of patients with 1- Visual Analogue Scale (VAS), 2- Neck Disability Index (NDI), 3- Modified Japanese Orthopaedic Association Cervical Myelopathy Score (mJOA.CMS), 4- American Spinal Injury Association Score (ASIAs). Immediate preoperative functional scoring, and 6 weeks, 3 months, 6 months, and 1 year postoperative.
Surgical Technique: The patient is handled in prone position after successful general anaesthesia with supported head to ensure that the Occipito-Cervical junction maintains in neutral position. The Occipito-Cervical junction is then exposed through a traditional midline longitudinal posterior skin incision extends from the external occipital protuberance to the C3-C4 level. The nuchal ligament is divided in the midline, and the occipital and cervical musculature is dissected subperiosteally. The suboccipital and cervical paraspinous muscles are retracted laterally to expose the underlying bony architecture. The posterior arch of C1 is exposed and the dissection is continued laterally in a subperiosteal manner to identify the horizontal segment of the vertebral arteries (VAs) which is enveloped in a dense venous plexus. The atlanto-occipital joint capsule is to be approx. 3 mm. Cranial to the superior margin of tht VA. Attention is then focused on the foramen magnum. Using curettes, the atlanto-occipital membrane is gently dissected from the foramen magnum laterally until the medial aspect of the occipital condyle is reached. At this point, the dissection continues laterally, maintaining bone contact to prevent injury to the horizontal segment of the VA along the condylar fossa, until the posterior condylar foramen and emissary vein are identified. The condylar foramen and vein represent the lateral extent of the dissection. At this stage, the operative field is prepared for instrumentation. Inserting the cervical screws first provides useful information about the axial location of the occipital condyles. The condylar entry point (CEP) is defined using a combination of radiographic and anatomic landmarks. The CEP is located (4 to 5 mm) lateral to the posteromedial edge of the condyle, and (2 mm) above the atlanto-occipital joint line. Pilot hole is then made at the entry point using an awl with slight cranial angulation to avoid injury to the horizontal segment of the VA. The pilot hole is then drilled under image-guidance in a convergent trajectory with (12 to 22 degrees) of medial angulation and (5 degrees) cranial angulation in the sagittal plane with the tip of the drill directed toward the basion, advancing slowly until the anterior cortical edge of the condyle is breached. The hole is tapped, and a (3.5 mm) polyaxial screw of an appropriate length (30 to 34 mm) is inserted bicortically into the occipital condyle. Approximately (12 mm) portion of the screw remains superficial to the posterior cortex of the condyle, allowing the polyaxial portion of the screw to lie above the posterior arch of C1, minimizing any chance of irritation of the VA by the rods.
Radiological Evaluation: 1- Preoperative: Plain X-ray (PXR) Antero-posterior (AP) and Lateral (Lat.) views to study the upper cervical instability indices and measurements, Multi-Slice Computed Tomography (MSCT) to study the boney Occipito-Cervical architecture for any fractures or anomalies, CT Angiography (CTA) to study the vertebral artery for anomaly especially in the horizontal segment of the VA, and Magnetic Resonance Imaging (MRI) to study the spinal cord for any compression signs. 2- Postoperative: Immediate (PXR) AP. and Lat. views for overall global assessment of the reduction and the construct installation. Then at 3 months, 6 months, and 1 year after surgery with flexion extension lateral view bending stress films for assessment of stability. Immediate (MSCT) to study the crucial screws placement estate for any breaches or successfulness, and after 1year for assessment of the fusion rate achieved.
Serial Follow-Up: after 6 weeks for clinical evaluation and functional scoring. At 3 and 6 months for radiological evaluation of stability, clinical evaluation and functional re-scoring. At 1 year for evaluation of fusion rate, clinical evaluation and over all resultant functional scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occipito-Cervical Instability | Experimental | Procedure: Occipital Condyle ScrewStabilization of the occipito-cervical junction by Occipital Condyle Screw (OCS) as a sole cranial anchor, with posterior bone graft. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with occipito-cervical instability of any cause, indicated for occipito-cervical fusion
Key exclusion criteria (3 listed)
- Fractured occipital condyle
- Congenital malformation of occipital condyle
- Congenital anomaly of the horizontal segment of the vertebral artery
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 |
|---|---|---|
| Occipital Condyle ScrewOccipito-Cervical Screw-Rod Fixation Technique | Procedure or surgery | Occipito-Cervical Instability |
Primary outcome
CT based classification for assessment of biological graft fusion
Time frame: At 6 months postoperative
A new assessment method of bony union using high-speed spiral CT imaging is proposed which reflects the gradually increasing biological stability of the construct. Grade I (complete fusion) implies cortical union of the allograft and central trabecular continuity. Grade II (partial fusion) implies cortical union of the structural allograft with partial trabecular incorporation. Grade III (unipolar pseudarthrosis) denotes superior or inferior cortical non-union of the central allograft with partial trabecular discontinuity centrally and Grade IV (bipolar pseudarthrosis) suggests both superior and inferior cortical non-union with a complete lack of central trabecular continuity.
4 secondary outcomes
Visual Analogue Scale for Pain (VAS Pain)
Time frame: Baseline measure, then at 2 weeks, 3 months and 6 months postoperative
Neck Disability Index (NDI)
Time frame: Baseline measure, then at 2 weeks, 3 months and 6 months postoperative
American Spinal Injury Association Score (ASIAs)
Time frame: Baseline and 3 months postoperative
Modified Japanese Orthopaedic Association Cervical Spondylotic Myelopathy Score (mJOA.CSM)
Time frame: Baseline and 3 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
- Background: PubMed 19057245Uribe JS, Ramos E, Vale F. Feasibility of occipital condyle screw placement for occipitocervical fixation: a cadaveric study and description of a novel technique. J Spinal Disord Tech. 2008 Dec;21(8):540-6. doi: 10.1097/BSD.0b013e31816d655e.
- Background: PubMed 20375778Uribe JS, Ramos E, Youssef AS, Levine N, Turner AW, Johnson WM, Vale FL. Craniocervical fixation with occipital condyle screws: biomechanical analysis of a novel technique. Spine (Phila Pa 1976). 2010 Apr 20;35(9):931-8. doi: 10.1097/BRS.0b013e3181c16f9a.
- Background: PubMed 19934947Uribe JS, Ramos E, Baaj A, Youssef AS, Vale FL. Occipital cervical stabilization using occipital condyles for cranial fixation: technical case report. Neurosurgery. 2009 Dec;65(6):E1216-7; discussion E1217. doi: 10.1227/01.NEU.0000349207.98394.FA.
- Background: PubMed 18939920La Marca F, Zubay G, Morrison T, Karahalios D. Cadaveric study for placement of occipital condyle screws: technique and effects on surrounding anatomic structures. J Neurosurg Spine. 2008 Oct;9(4):347-53. doi: 10.3171/SPI.2008.9.10.347.
- Background: PubMed 24866907Ahmadian A, Dakwar E, Vale FL, Uribe JS. Occipitocervical fusion via occipital condylar fixation: a clinical case series. J Spinal Disord Tech. 2014 Jun;27(4):232-6. doi: 10.1097/BSD.0b013e31825bfeea.
- Background: PubMed 17497188Tan GH, Goss BG, Thorpe PJ, Williams RP. CT-based classification of long spinal allograft fusion. Eur Spine J. 2007 Nov;16(11):1875-81. doi: 10.1007/s00586-007-0376-0. Epub 2007 May 12.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mohamed El-Meshtawy, MD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Occipital Condyle Screw in people with Cervical Instabilities Spine, run by Assiut University.
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 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: status not confirmed, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Shawky, MD (+201010212222, ahsh313@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT based classification for assessment of biological graft fusion (time frame: At 6 months postoperative). 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 NCT03250611, which also lists 6 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 15 Aug 2017.