Thoracolumbar SpineNCT05456633
Clinical and Radiographic Outcomes of Spine Surgeries Utilizing Capri Cervical and Thoracolumbar Corpectomy Cage Systems
An observational study of Thoracolumbar Spine and Cervical Spine Injury, run by K2M, Inc..
Trial summary
This is a retrospective and prospective observational, multi center study of subjects who have undergone or will undergo vertebral body replacement surgery in the cervical or thoracolumbar spine utilizing Stryker Capri Corpectomy Cages. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thoracolumbar Spine, Cervical Spine Injury
- What is being tested?
- Capri Cervical Static, CAPRI Static Expandable and Capri Thoracolumbar
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Aug 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The sample size for this study will be a total of 126 subjects planned to receive one of the Capri Corpectomy systems mentioned below at up to 20 sites in the United State: * 42 subjects for Capri Cervical 3D Static * 42 subjects for Capri Cervical 3D Expandable * 42 subjects for Capri Thoracolumbar Expandable This sample size allows for up to a 15% loss-to-follow-up at 24 months. The sample size analysis below indicates that N=36 per device are needed for 80% power to meet the a priori performance goal
Who may be able to join
- Skeletally mature
- Willingness and ability to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent form. For fully retrospective enrollments, i.e., subjects that already have 24-month follow-up data available, the Principal Investigator will request a waiver of the written informed consent requirement.
- Has undergone or will undergo VBR in the cervical spine (C2 to T1 in the USA, C3 to C7 outside of the USA) using either Capri Cervical 3D Static OR Capri Cervical 3D Expandable to replace diseased or damaged vertebral bodies due to tumor, trauma (i.e., fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spine cord and neural tissues in cervical degenerative disorders -OR- Has undergone or will undergo VBR in the thoracolumbar spine (T1 to L5) using Capri Thoracolumbar Expandable to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture)
- Score at least 30 points on the ODI or at least 30 points on the NDI at screening (or before surgery for retrospective enrollment) (on a 100-point scale)
Who cannot join
- Presence of infection, except within the spinal indications for use of this product
- Pregnancy (pregnant at the time of enrollment or intends to become pregnant during the course of the study)
- Metabolic disorders of calcified tissues
- Grossly distorted anatomy
- Inadequate tissue coverage
- Drug / alcohol abuse
Show all 20Show fewer
- Mental illness such as a psychiatric or cognitive impairment, that in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements or patient reported outcomes (e.g., Alzheimer's Disease)
- General neurological conditions
- Immunosuppressive disorders
- Subjects with known sensitivities to materials in the device
- Obesity defined as a BMI greater than 30
- Subjects who are unwilling to restrict activities or follow medical advice
- Any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery
- Biological factors such as smoking, use of nonsteroidal anti-inflammatory agents, use of anticoagulants, etc.
- Subjects that adhere to the specified washout period detailed below can be enrolled: Smoking cessation must occur at a minimum of 4 weeks prior to surgery; Nonsteroidal anti-inflammatories (NSAIDs) should be stopped at a minimum of 7 days prior to surgery; Anticoagulants should be stopped at the discretion of the operating surgeon as the washout period varies for each medication
- Trauma subjects that are unable to adhere to the washout period can be enrolled; however, the aforementioned biological factors will need to be documented during data collection
- Prior fusion at the level(s) to be treated
- Incarcerated at the time of study enrollment
- Current participation in an investigational study that may impact study outcomes
- Involved in current or pending spinal litigation or a workman compensation claim
About this study
Official title: Multi-Center, Retrospective and Prospective Evaluation for Clinical and Radiographic Outcomes of Spine Surgeries Utilizing Capri Cervical and Thoracolumbar Corpectomy Cage Systems: Observational Post Market Clinical Follow-Up Study
This is a retrospective and prospective observational, multi center study of subjects who have undergone or will undergo vertebral body replacement surgery in the cervical or thoracolumbar spine utilizing Stryker Capri Corpectomy Cages.
The primary study hypothesis to determine effectiveness, is that the mean improvement in NDI (cervical) or ODI (thoracolumbar) score from baseline meets or exceeds 15-points at 24 months for Stryker Capri Corpectomy Cage systems individually.
Read the detailed description
Corpectomy procedures are utilized to treat a variety of spinal pathologies including tumor, often as a result of metastatic spine disease, fracture frequently attributed to trauma, osteomyelitis (infection), and degenerative disorders which require reconstruction to achieve decompression of the spinal cord or neural tissues. Patients may present with pain, spinal instability, and neurological deficits. Corpectomy involves a resection or excision of the affected vertebrae and intervertebral disc(s), followed by placement of a vertebral body replacement (VBR) to reconstruct the anterior column of the spine and restore stability and alignment.
Common indications for VBR procedures include spinal instability due to vertebral fractures, vertebral compression fractures, and fractures related to malignancy or infection and control of disease, such as metastatic disease in the spine. Causes of spinal fractures may include falls, sports, and motor vehicle accidents. Spinal tumors are often caused by metastases of the skeletal system, which commonly affect the spine. Additionally, VBR procedures may be considered in response to cervical spondylotic myelopathy which is a progressive degenerative disease and a common cause of cervical spinal cord dysfunction and cervical myelopathy in people over the age of 55. Corpectomy (or vertebrectomy) with reconstruction has become a common surgical procedure used for decompression and reconstruction of the spine. Traditionally, reconstruction has included autograft, allograft, and bone substitutes; however, the use of grafts alone have been reported to lead to complications such as donor site morbidity, high rates of pseudarthrosis, and delayed union. The evolution of corpectomy cages has led to improvements in both clinical and radiographic outcomes. Titanium mesh cages were one of the earliest types of non-graft-based corpectomy cages, providing a biocompatible method of rapidly stabilizing the affected segments, reducing donor site morbidity, and improving outcomes.
This study will examine use of the Capri Corpectomy Cage systems in cervical and/or thoracolumbar cases in the treatment of trauma, tumor, infection (cervical only), or degeneration (cervical only) using static (cervical only) or expandable (cervical and thoracolumbar) cages. Clinical efficacy and safety will be assessed in this post-market study through evaluation of patient outcomes in comparison to baseline, pre-operative conditions.
Capri Corpectomy system implants are VBR devices that are designed in a variety of lengths, widths, and heights to match the patient's anatomy. The caudal and cephalad ends of the implant have teeth which are designed to engage with the vertebral body endplates. The side walls of the implants contain windows that may be used for graft incorporation. Instruments are used for inserting the associated implant components using standard surgical techniques. There are curettes, scrapers, and box chisels for preparing the disc spaces and vertebral body endplates. Insertion instruments are available for inserting the implant. Capri Corpectomy Cage systems are available as cervical static cages (comprised of titanium alloy) and cervical or thoracolumbar adjustable (i.e., expandable) cages (comprised of titanium alloy and cobalt chrome). Devices may be implanted via posterior, anterior, or lateral approaches.
- Conditions
- Thoracolumbar Spine, Cervical Spine Injury
- Being tested
- Capri Cervical Static, CAPRI Static Expandable, Capri Thoracolumbar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capri Cervical StaticDevice
When used in the cervical spine (C2-T1), CAPRI Static cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders.
CAPRI Static ExpandableOther
When used in the cervical spine (C2-T1), CAPRI Static Expandable cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders.
Capri ThoracolumbarDevice
Intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture).
| Study group | Role | What they receive |
|---|---|---|
| Capri Cervical 3D Static | Subjects who have undergone or will undergo VBR in the cervical spine (C2 to T1 in the USA, C3 to C7 outside of the USA) to replace diseased or damaged vertebral bodies due to tumor, trauma (i.e., fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spine cord and neural tissues in cervical degenerative disorders Receives: Device: Capri Cervical Static | |
| Capri Cervical 3D Expendable | Subjects who have undergone or will undergo VBR in the cervical spine (C2 to T1 in the USA, C3 to C7 outside of the USA) to replace diseased or damaged vertebral bodies due to tumor, trauma (i.e., fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spine cord and neural tissues in cervical degenerative disorders Receives: Other: CAPRI Static Expandable | |
| Capri Thoracolumbar Expandable | Subjects who have undergone or will undergo VBR in the thoracolumbar spine (T1 to L5) with Capri Thoracolumbar Expandable to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture) Receives: Device: Capri Thoracolumbar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean improvement in NDI score
Mean improvement in NDI score over baseline that meets or exceeds 15 points (on a 100 point scale) at 24 months (cervical)
Measured: 24 Months
Mean ODI improvement
Mean ODI improvement over baseline that meets or exceeds 15 points (on a 100-point scale) at 24 months (thoracolumbar)
Measured: 24 Months
Secondary outcomes (19)
NDI or ODI
Patient-Reported Outcome Measures
Measured: Initial Post-Op to 24 Months
Visual Analogue Scale (VAS)
Patient-Reported Outcome Measures
Measured: Initial Post-Op to 24 Months
EuroQol-5 Dimensions-5 Levels (EQ 5D-5L)
Patient-Reported Outcome Measures
Measured: Initial Post-Op to 24 Months
Fusion or non-union
Radiographic Assessments: Effectiveness
Measured: 24 Months
Range of motion
Radiographic Assessments: Effectiveness
Measured: 24 Months
Translational motion
Radiographic Assessments: Effectiveness
Measured: 24 Months
Disc height
Radiographic Assessments: Effectiveness
Measured: 24 Months
Surgery Time
Clinical Observations
Measured: During Surgery
Anesthesia Time
Clinical Observations
Measured: During Surgery
Estimated blood loss
Clinical Observations
Measured: During Surgery
Length of hospital stay on day of Surgery / Pre-Discharge
Clinical Observations
Measured: During Surgery
Patient Satisfaction at 12 Month
Clinical Observations
Measured: 12 Months
Patient Satisfaction
Clinical Observations
Measured: 24 Months
Use of pain medication post surgery at all visits
Clinical Observations
Measured: Post surgery - 24 Months
Neurological Examination
Clinical Observations
Measured: 12 Months
Subsidence
X-Ray Safety Assessment
Measured: 12 and 24 Months
Device Migration
X-Ray Safety Assessment
Measured: 12 and 24 Months
Adjacent Segment Degeneration
X-Ray Safety Assessment
Measured: 12 and 24 Months
Device and supplemental fixation breakage
X-Ray Safety Assessment
Measured: 12 and 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study startOct 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2026 (estimated)
Why it stopped: The study has been withdrawn and no participant was enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracolumbar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- K2M, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VB Spine, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456633
- Sponsor's protocol ID
- CAS-031
- Status last verified
- Sep 2023
- First submitted
- 11 Jul 2022
- Last updated
- 25 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Retrospective and Prospective Evaluation for Clinical and Radiographic Outcomes of Spine Surgeries Utilizing Capri Cervical and Thoracolumbar Corpectomy Cage Systems: Observational Post Market Clinical Follow-Up Study
- ClinicalTrials.gov ID
- NCT05456633
- Acronym / sponsor ID
- CAS-031
- Conditions
- Thoracolumbar Spine, Cervical Spine Injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study has been withdrawn and no participant was enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- K2M, Inc.Industry (pharma, biotech, devices)
- Collaborators
- VB Spine, LLC
- Study start
- Oct 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 Jul 2022 (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 is a retrospective and prospective observational, multi center study of subjects who have undergone or will undergo vertebral body replacement surgery in the cervical or thoracolumbar spine utilizing Stryker Capri Corpectomy Cages.
The primary study hypothesis to determine effectiveness, is that the mean improvement in NDI (cervical) or ODI (thoracolumbar) score from baseline meets or exceeds 15-points at 24 months for Stryker Capri Corpectomy Cage systems individually.
Detailed description
Corpectomy procedures are utilized to treat a variety of spinal pathologies including tumor, often as a result of metastatic spine disease, fracture frequently attributed to trauma, osteomyelitis (infection), and degenerative disorders which require reconstruction to achieve decompression of the spinal cord or neural tissues. Patients may present with pain, spinal instability, and neurological deficits. Corpectomy involves a resection or excision of the affected vertebrae and intervertebral disc(s), followed by placement of a vertebral body replacement (VBR) to reconstruct the anterior column of the spine and restore stability and alignment.
Common indications for VBR procedures include spinal instability due to vertebral fractures, vertebral compression fractures, and fractures related to malignancy or infection and control of disease, such as metastatic disease in the spine. Causes of spinal fractures may include falls, sports, and motor vehicle accidents. Spinal tumors are often caused by metastases of the skeletal system, which commonly affect the spine. Additionally, VBR procedures may be considered in response to cervical spondylotic myelopathy which is a progressive degenerative disease and a common cause of cervical spinal cord dysfunction and cervical myelopathy in people over the age of 55. Corpectomy (or vertebrectomy) with reconstruction has become a common surgical procedure used for decompression and reconstruction of the spine. Traditionally, reconstruction has included autograft, allograft, and bone substitutes; however, the use of grafts alone have been reported to lead to complications such as donor site morbidity, high rates of pseudarthrosis, and delayed union. The evolution of corpectomy cages has led to improvements in both clinical and radiographic outcomes. Titanium mesh cages were one of the earliest types of non-graft-based corpectomy cages, providing a biocompatible method of rapidly stabilizing the affected segments, reducing donor site morbidity, and improving outcomes.
This study will examine use of the Capri Corpectomy Cage systems in cervical and/or thoracolumbar cases in the treatment of trauma, tumor, infection (cervical only), or degeneration (cervical only) using static (cervical only) or expandable (cervical and thoracolumbar) cages. Clinical efficacy and safety will be assessed in this post-market study through evaluation of patient outcomes in comparison to baseline, pre-operative conditions.
Capri Corpectomy system implants are VBR devices that are designed in a variety of lengths, widths, and heights to match the patient's anatomy. The caudal and cephalad ends of the implant have teeth which are designed to engage with the vertebral body endplates. The side walls of the implants contain windows that may be used for graft incorporation. Instruments are used for inserting the associated implant components using standard surgical techniques. There are curettes, scrapers, and box chisels for preparing the disc spaces and vertebral body endplates. Insertion instruments are available for inserting the implant. Capri Corpectomy Cage systems are available as cervical static cages (comprised of titanium alloy) and cervical or thoracolumbar adjustable (i.e., expandable) cages (comprised of titanium alloy and cobalt chrome). Devices may be implanted via posterior, anterior, or lateral approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Capri Cervical 3D Static | – | Device: Capri Cervical StaticSubjects who have undergone or will undergo VBR in the cervical spine (C2 to T1 in the USA, C3 to C7 outside of the USA) to replace diseased or damaged vertebral bodies due to tumor, trauma (i.e., fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spine cord and neural tissues in cervical degenerative disorders |
| Capri Cervical 3D Expendable | – | Other: CAPRI Static ExpandableSubjects who have undergone or will undergo VBR in the cervical spine (C2 to T1 in the USA, C3 to C7 outside of the USA) to replace diseased or damaged vertebral bodies due to tumor, trauma (i.e., fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spine cord and neural tissues in cervical degenerative disorders |
| Capri Thoracolumbar Expandable | – | Device: Capri ThoracolumbarSubjects who have undergone or will undergo VBR in the thoracolumbar spine (T1 to L5) with Capri Thoracolumbar Expandable to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The sample size for this study will be a total of 126 subjects planned to receive one of the Capri Corpectomy systems mentioned below at up to 20 sites in the United State: * 42 subjects for Capri Cervical 3D Static * 42 subjects for Capri Cervical 3D Expandable * 42 subjects for Capri Thoracolumbar Expandable This sample size allows for up to a 15% loss-to-follow-up at 24 months. The sample size analysis below indicates that N=36 per device are needed for 80% power to meet the a priori performance goal
Key inclusion criteria (5 listed)
- Skeletally mature
- Willingness and ability to comply with the requirements of the protocol including follow-up requirements
- Willing and able to sign a study specific informed consent form. For fully retrospective enrollments, i.e., subjects that already have 24-month follow-up data available, the Principal Investigator will request a waiver of the written informed consent requirement.
- Has undergone or will undergo VBR in the cervical spine (C2 to T1 in the USA, C3 to C7 outside of the USA) using either Capri Cervical 3D Static OR Capri Cervical 3D Expandable to replace diseased or damaged vertebral bodies due to tumor, trauma (i.e., fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spine cord and neural tissues in cervical degenerative disorders -OR- Has undergone or will undergo VBR in the thoracolumbar spine (T1 to L5) using Capri Thoracolumbar Expandable to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture)
- Score at least 30 points on the ODI or at least 30 points on the NDI at screening (or before surgery for retrospective enrollment) (on a 100-point scale)
Key exclusion criteria (20 listed)
- Presence of infection, except within the spinal indications for use of this product
- Pregnancy (pregnant at the time of enrollment or intends to become pregnant during the course of the study)
- Metabolic disorders of calcified tissues
- Grossly distorted anatomy
- Inadequate tissue coverage
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 |
|---|---|---|
| Capri Cervical StaticWhen used in the cervical spine (C2-T1), CAPRI Static cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. | Device | Capri Cervical 3D Static |
| CAPRI Static ExpandableWhen used in the cervical spine (C2-T1), CAPRI Static Expandable cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. | Other | Capri Cervical 3D Expendable |
| Capri ThoracolumbarIntended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). | Device | Capri Thoracolumbar Expandable |
Primary outcome
Mean improvement in NDI score
Time frame: 24 Months
Mean improvement in NDI score over baseline that meets or exceeds 15 points (on a 100 point scale) at 24 months (cervical)
Mean ODI improvement
Time frame: 24 Months
Mean ODI improvement over baseline that meets or exceeds 15 points (on a 100-point scale) at 24 months (thoracolumbar)
19 secondary outcomes
NDI or ODI
Time frame: Initial Post-Op to 24 Months
Visual Analogue Scale (VAS)
Time frame: Initial Post-Op to 24 Months
EuroQol-5 Dimensions-5 Levels (EQ 5D-5L)
Time frame: Initial Post-Op to 24 Months
Fusion or non-union
Time frame: 24 Months
Range of motion
Time frame: 24 Months
Translational motion
Time frame: 24 Months
Disc height
Time frame: 24 Months
Surgery Time
Time frame: During Surgery
Anesthesia Time
Time frame: During Surgery
Estimated blood loss
Time frame: During Surgery
Length of hospital stay on day of Surgery / Pre-Discharge
Time frame: During Surgery
Patient Satisfaction at 12 Month
Time frame: 12 Months
Patient Satisfaction
Time frame: 24 Months
Use of pain medication post surgery at all visits
Time frame: Post surgery - 24 Months
Neurological Examination
Time frame: 12 Months
Subsidence
Time frame: 12 and 24 Months
Device Migration
Time frame: 12 and 24 Months
Adjacent Segment Degeneration
Time frame: 12 and 24 Months
Device and supplemental fixation breakage
Time frame: 12 and 24 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracolumbar Spine and Cervical Spine Injury, run by K2M, Inc..
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 5 inclusion and 20 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: withdrawn, as of the sponsor's last update on 25 Sep 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean improvement in NDI score (time frame: 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2023.