Cervical DeformitySymphonyNCT04912674
Evaluation of Symphony™ Posterior Cervical System for Surgical Treatment of Adult Cervical Deformity
An observational study of Cervical Deformity, run by International Spine Study Group Foundation at 6 sites in United States.
Trial summary
Multi-center, prospective, non-randomized study to evaluate Symphony™ Posterior Cervical System in the setting of surgical treatment of adult cervical deformity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Deformity
- What is being tested?
- Symphony OCT System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Jul 2021to 12 Jul 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cervical deformity patients from spine surgeon clinic
Who may be able to join
- ≥18 years old at time of treatment
- Patient undergoing a posterior cervical instrumented fusion using the DePuy Synthes SymphonyTM OCT System for the treatment of adult cervical deformity, defined as any of below criteria:
- Loss of cervical lordosis (≤ 0° cervical lordosis C2-7)
- ≥ 5° of kyphosis across any 1 or 2 cervical segments
- ≥ 10° of cervical scoliosis
- C2-C7 SVA ≥ 4cm
Show all 11Show fewer
- T1 Slope minus Cervical Lordosis ≥ 20°
- Grade I or greater Spondylolisthesis at any segment C1-T1
- Horizontal Gaze ≤ 0 or ≥ 11
- Plan for surgical correction of cervical deformity in the next 6 months
- Willing to provide consent and complete study forms at baseline and follow-up intervals
Who cannot join
- Active spine tumor or infection
- Deformity due to acute trauma
- Unwilling to provide consent or to complete study forms
- Prisoner
- Pregnant or immediate plans to get pregnant
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Virginia
Charlottesville, Virginia, 22908
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, Colorado, 80128
Duke University
Durham, North Carolina, 27710
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
University of California Davis
Sacramento, California, 95817
Washington University
St Louis, Missouri, 63110
About this study
Official title: Prospective Evaluation of Symphony™ Posterior Cervical System for Surgical Treatment of Adult Cervical Deformity: A Multi-Center Study
Multi-center, prospective, non-randomized study to evaluate Symphony™ Posterior Cervical System in the setting of surgical treatment of adult cervical deformity.
Read the detailed description
Specific Aims:
- Evaluate outcomes for operative treatment of adult cervical deformity patients treated with posterior spinal fusion using SymphonyTM posterior cervical system at 6 weeks, 1 year, and 2 year follow up. Outcome metrics will include standardized patient reported outcome measures, radiographic analysis of deformity correction and spinal alignment.
- Evaluate rates and risk factors for perioperative complications and need for revision surgery at 6 weeks, 1 year, and 2 years postoperatively.
- Develop and validate a surgical invasiveness index for cervical deformity surgical procedures
- Validate the cervical deformity frailty index previously developed by the ISSG and further optimize this index
- Establish adult cervical deformity specific thresholds for minimal clinically important difference (MCID) for standard outcomes measures using a patient satisfaction anchor
- Develop a series of predictive models for adult cervical deformity surgery, including outcomes (e.g. overall change and achievement of MCID), occurrence of complications, and radiographic changes
- Assess the psychological impact of adult cervical deformity, how psychological measures change following surgical treatment, and whether there are correlations between baseline psychological factors and outcomes following surgery
- Assess baseline functional measures (e.g. grip strength) for adult cervical deformity patients presenting for surgery, assess how these functional measures change following surgery, and assess whether there are correlations between baseline functional measures and likelihood to improve following surgery
- Assess baseline narcotic use among adult cervical deformity patients presenting for surgery
- Assess changes in narcotic use from baseline to follow-up intervals after surgical treatment for adult cervical deformity
- Assess for correlations between narcotic use (baseline and follow-up) and outcomes following surgical treatment for adult cervical deformity
- Assess the impact of osteopenia and osteoporosis on patient frailty, complications, and maintenance of deformity correction
- Define clinical and demographic features of the population afflicted with cervical deformity (e.g., age, gender, comorbidities, disability, health-related quality of life)
- Assess for correlations between radiographic parameters and degree of disability/pain at baseline
- Assess and describe surgical strategies used to address cervical deformity
- Define complications and rates of complications (perioperative and delayed) associated with the surgical treatment of cervical deformity
- Assess the role/need for pre/post operative tracheostomy and PEG
- Evaluate and compare radiographic changes of sagittal spinal alignment (focal, regional, and global) and pelvic parameters pre and post cervical deformity surgery.
- Develop predictive formulas of post-operative alignments based on surgical techniques employed for correction
- Identify risk factors related to poor clinical outcomes
- Define potential impact of complications on clinical/radiographic outcomes
- Determine reoperation rates over two-year follow-up period
- Assess change in subaxial alignment after occiput to C2 fusion
- Assess the effect of C1-2 lordosis and C1-2 fusion on subaxial alignment and outcome
- Assess outcomes of long fusions involving the occiput related to head center of gravity and regional and global balance
- Assess outcomes of occipital-cervical-thoracic fusion on cervical alignment and global alignment
- Evaluate clinical outcomes (short- and long-term) following cervical deformity surgery
- Assess cost-effectiveness of adult cervical deformity surgery
- Correlate different measures of frailty, including Edmonton, CHSA, and ISSG.
- Conditions
- Cervical Deformity
- Being tested
- Symphony OCT System
- Keywords
- Cervical deformity, Kyphosis, Scoliosis
- Medical subject headings
- Kyphosis, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symphony OCT SystemDevice
Surgical intervention will be patient specified by treating surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Operative | Inclusion Criteria:
1. ≥18 years old at time of treatment
2. Patient undergoing a posterior cervical instrumented fusion using the DePuy Synthes SymphonyTM OCT System for the treatment of adult cervical deformity, defined as any of below criteria:
1. Loss of cervical lordosis (≤ 0° cervical lordosis C2-7)
2. ≥ 5° of kyphosis across any 1 or 2 cervical segments
3. ≥ 10° of cervical scoliosis
4. C2-C7 SVA ≥ 4cm
5. T1 Slope minus Cervical Lordosis ≥ 20°
6. Grade I or greater Spondylolisthesis at any segment C1-T1
7. Horizontal Gaze ≤ 0 or ≥ 11
3. Plan for surgical correction of cervical deformity in the next 6 months
4. Willing to provide consent and complete study forms at baseline and follow-up intervals
Exclusion Criteria:
1. Active spine tumor or infection
2. Deformity due to acute trauma
3. Unwilling to provide consent or to complete study forms
4. Prisoner
5. Pregnant or immediate plans to get pregnant Receives: Device: Symphony OCT System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Numeric rating scale (NRS) - Headaches
Self reported pain in Head where 0=no pain/10=severe pain
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Pain Numeric rating scale (NRS) - Neck
Self-reported pain in Neck where 0=no pain/10=severe pain
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Pain Numeric rating scale (NRS) - Upper extremity
Self-reported pain in Arms where 0=no pain/10=severe pain
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Pain Numeric rating scale (NRS) - Lower extremity
Self-reported pain in Legs where 0=no pain/10=severe pain
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Pain Numeric rating scale (NRS) - Back
Self-reported pain in Back where 0=no pain/10=severe pain
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Neck Disability Index (NDI)
Patient reported neck disability tool
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Veterans RAND 12 Item Health Survey (VR-12)
Patient reported outcome
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
Computer adaptive PROs
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
Computer adaptive PROs
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference
Computer adaptive PROs
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function
Computer adaptive PROs
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (Role)
Computer adaptive PROs
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)
Computer adaptive PROs
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Spine Radiographs
Radiographic parameters (Cervical lordosis, Kyphosis, Scoliosis; Global balance in coronal and sagittal planes of the spine; pelvic parameters (pelvic incidence, tilt, slope) and bony fusion status
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Modified Japanese Orthopaedic Association Scale (mJOA)
Patient reported outcome measuring functional status using scale of 0 to 18. The higher the score, the less disability.
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Secondary outcomes (6)
EAT-10
Measures swallowing difficulties as reported by the patient.
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Voice Handicap Index (VHI-10)
Measures voice handicap as reported by the patient.
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Adverse events
Any adverse events that occur during study participation \& meeting study established reporting criteria
Measured: 6 weeks, 1 year, and 2 years
Edmonton Frail Scale
Frailty scale from 0 to 17 where the higher the score the more frail the patient
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
CHSA Frail Scale
Clinical Frailty Scale from 1 to 9 where the higher the score, the more frail the patient
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Dynamometer Hand Grip Strength test
With patient seated, patient will squeeze the dynamometer as hard as he/she can with each hand.
Measured: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start12 Jul 2021
- Primary completion12 Jul 2027 (estimated)
- Study completion12 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DeformityStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Spine Study Group Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes
- Responsible party
- Sponsor
- Investigators
- Justin Smith, MD, PhD, Principal investigator, University of VirginiaChristopher Shaffrey, MD, Principal investigator, Duke UniversityShay Bess, MD, Principal investigator, Denver Int'l Spine Center, Rocky Mountain Hospital for Children & Presbyterian St. Luke's MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912674
- Sponsor's protocol ID
- 2140
- Acronym
- Symphony
- Status last verified
- Feb 2026
- First submitted
- 28 May 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Symphony™ Posterior Cervical System for Surgical Treatment of Adult Cervical Deformity: A Multi-Center Study
- ClinicalTrials.gov ID
- NCT04912674
- Acronym / sponsor ID
- Symphony / 2140
- Conditions
- Cervical Deformity
- Keywords
- Cervical deformity, Kyphosis, Scoliosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- International Spine Study Group FoundationUniversity, hospital or other
- Collaborators
- DePuy Synthes
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 12 Jul 2027 (estimated)
- Study completion
- 12 Jul 2027 (estimated)
- First posted
- 3 Jun 2021 (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.
Multi-center, prospective, non-randomized study to evaluate Symphony™ Posterior Cervical System in the setting of surgical treatment of adult cervical deformity.
Detailed description
Specific Aims:
- Evaluate outcomes for operative treatment of adult cervical deformity patients treated with posterior spinal fusion using SymphonyTM posterior cervical system at 6 weeks, 1 year, and 2 year follow up. Outcome metrics will include standardized patient reported outcome measures, radiographic analysis of deformity correction and spinal alignment.
- Evaluate rates and risk factors for perioperative complications and need for revision surgery at 6 weeks, 1 year, and 2 years postoperatively.
- Develop and validate a surgical invasiveness index for cervical deformity surgical procedures
- Validate the cervical deformity frailty index previously developed by the ISSG and further optimize this index
- Establish adult cervical deformity specific thresholds for minimal clinically important difference (MCID) for standard outcomes measures using a patient satisfaction anchor
- Develop a series of predictive models for adult cervical deformity surgery, including outcomes (e.g. overall change and achievement of MCID), occurrence of complications, and radiographic changes
- Assess the psychological impact of adult cervical deformity, how psychological measures change following surgical treatment, and whether there are correlations between baseline psychological factors and outcomes following surgery
- Assess baseline functional measures (e.g. grip strength) for adult cervical deformity patients presenting for surgery, assess how these functional measures change following surgery, and assess whether there are correlations between baseline functional measures and likelihood to improve following surgery
- Assess baseline narcotic use among adult cervical deformity patients presenting for surgery
- Assess changes in narcotic use from baseline to follow-up intervals after surgical treatment for adult cervical deformity
- Assess for correlations between narcotic use (baseline and follow-up) and outcomes following surgical treatment for adult cervical deformity
- Assess the impact of osteopenia and osteoporosis on patient frailty, complications, and maintenance of deformity correction
- Define clinical and demographic features of the population afflicted with cervical deformity (e.g., age, gender, comorbidities, disability, health-related quality of life)
- Assess for correlations between radiographic parameters and degree of disability/pain at baseline
- Assess and describe surgical strategies used to address cervical deformity
- Define complications and rates of complications (perioperative and delayed) associated with the surgical treatment of cervical deformity
- Assess the role/need for pre/post operative tracheostomy and PEG
- Evaluate and compare radiographic changes of sagittal spinal alignment (focal, regional, and global) and pelvic parameters pre and post cervical deformity surgery.
- Develop predictive formulas of post-operative alignments based on surgical techniques employed for correction
- Identify risk factors related to poor clinical outcomes
- Define potential impact of complications on clinical/radiographic outcomes
- Determine reoperation rates over two-year follow-up period
- Assess change in subaxial alignment after occiput to C2 fusion
- Assess the effect of C1-2 lordosis and C1-2 fusion on subaxial alignment and outcome
- Assess outcomes of long fusions involving the occiput related to head center of gravity and regional and global balance
- Assess outcomes of occipital-cervical-thoracic fusion on cervical alignment and global alignment
- Evaluate clinical outcomes (short- and long-term) following cervical deformity surgery
- Assess cost-effectiveness of adult cervical deformity surgery
- Correlate different measures of frailty, including Edmonton, CHSA, and ISSG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operative | – | Device: Symphony OCT SystemInclusion Criteria: 1. ≥18 years old at time of treatment 2. Patient undergoing a posterior cervical instrumented fusion using the DePuy Synthes SymphonyTM OCT System for the treatment of adult cervical deformity, defined as any of below criteria: 1. Loss of cervical lordosis (≤ 0° cervical lordosis C2-7) 2. ≥ 5° of kyphosis across any 1 or 2 cervical segments 3. ≥ 10° of cervical scoliosis 4. C2-C7 SVA ≥ 4cm 5. T1 Slope minus Cervical Lordosis ≥ 20° 6. Grade I or greater Spondylolisthesis at any segment C1-T1 7. Horizontal Gaze ≤ 0 or ≥ 11 3. Plan for surgical correction of cervical deformity in the next 6 months 4. Willing to provide consent and complete study forms at baseline and follow-up intervals Exclusion Criteria: 1. Active spine tumor or infection 2. Deformity due to acute trauma 3. Unwilling to provide consent or to complete study forms 4. Prisoner 5. Pregnant or immediate plans to get pregnant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cervical deformity patients from spine surgeon clinic
Key inclusion criteria (11 listed)
- ≥18 years old at time of treatment
- Patient undergoing a posterior cervical instrumented fusion using the DePuy Synthes SymphonyTM OCT System for the treatment of adult cervical deformity, defined as any of below criteria:
- Plan for surgical correction of cervical deformity in the next 6 months
- Willing to provide consent and complete study forms at baseline and follow-up intervals
Key exclusion criteria (5 listed)
- Active spine tumor or infection
- Deformity due to acute trauma
- Unwilling to provide consent or to complete study forms
- Prisoner
- Pregnant or immediate plans to get pregnant
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 |
|---|---|---|
| Symphony OCT SystemSurgical intervention will be patient specified by treating surgeon. | Device | Operative |
Primary outcome
Pain Numeric rating scale (NRS) - Headaches
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Self reported pain in Head where 0=no pain/10=severe pain
Pain Numeric rating scale (NRS) - Neck
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Self-reported pain in Neck where 0=no pain/10=severe pain
Pain Numeric rating scale (NRS) - Upper extremity
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Self-reported pain in Arms where 0=no pain/10=severe pain
Pain Numeric rating scale (NRS) - Lower extremity
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Self-reported pain in Legs where 0=no pain/10=severe pain
Pain Numeric rating scale (NRS) - Back
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Self-reported pain in Back where 0=no pain/10=severe pain
Neck Disability Index (NDI)
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient reported neck disability tool
Veterans RAND 12 Item Health Survey (VR-12)
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient reported outcome
Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Computer adaptive PROs
Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Computer adaptive PROs
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Computer adaptive PROs
Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Computer adaptive PROs
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (Role)
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Computer adaptive PROs
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Computer adaptive PROs
Spine Radiographs
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Radiographic parameters (Cervical lordosis, Kyphosis, Scoliosis; Global balance in coronal and sagittal planes of the spine; pelvic parameters (pelvic incidence, tilt, slope) and bony fusion status
Modified Japanese Orthopaedic Association Scale (mJOA)
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Patient reported outcome measuring functional status using scale of 0 to 18. The higher the score, the less disability.
6 secondary outcomes
EAT-10
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Voice Handicap Index (VHI-10)
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Adverse events
Time frame: 6 weeks, 1 year, and 2 years
Edmonton Frail Scale
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
CHSA Frail Scale
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
Dynamometer Hand Grip Strength test
Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up
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 17 Feb 2026.
- 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.
Justin Smith, MD, PhD principal investigator
University of Virginia
Christopher Shaffrey, MD principal investigator
Duke University
Shay Bess, MD principal investigator
Denver Int'l Spine Center, Rocky Mountain Hospital for Children & Presbyterian St. Luke's MC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Deformity, run by International Spine Study Group Foundation at 6 sites in United States.
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 11 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 Numeric rating scale (NRS) - Headaches (time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up). The study lists 15 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 17 Feb 2026.