Cervical DeformityPCD 2NCT04194996
Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0
An observational study of Cervical Deformity, run by International Spine Study Group Foundation at 16 sites in United States.
Trial summary
Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal 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?
- Surgical intervention
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Aug 2019to 31 Jul 2030
- 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: Spine Surgeon Clinic
Who may be able to join
- ≥18 years old at time of treatment
- Diagnosis of cervical deformity- must meet one or more of the following criteria:
- C2-C7 sagittal kyphosis (Cobb > 15 degrees)
- T1S-CL > 35o
- Segmental cervical kyphosis > 10 degrees between any 2 vertebra between C2-T1 or > 15 degrees across any 3 vertebra between C2-T1
- Cervical scoliosis > 10 degrees (Cobb angle must include end vertebra within the cervical spine)
Show all 14Show fewer
- C2-C7 SVA > 4cm
- McGregor's slope > 20 degrees or CBVA > 25 degrees OR
- Planned Revision surgery for proximal junctional failure with an anticipated UIV in the cervical spine and an anticipated LIV in the thoracic or lumbar spine.
- 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
- Upright AP/Lateral entire spine (EOS or 36")
- Upright AP/Lateral C spine ONLY IF C spine is not completely visible on entire spine films
- Flex/Ext lateral C spine. Admin may allow exceptions w/ valid documentation.
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
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ray Pinteric contact
16 sites in 1 country
United States16 sites, 13 recruiting
- Completed
University of Michigan, Department of Neurosurgery
Ann Arbor, Michigan, 48109
- Recruiting
Johns Hopkins University, Department of Neurological Surgery
Baltimore, Maryland, 21224
Ahmed Sulieman, asuliem2@jh.edu
Khaled Kebaish, MD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Lorrie Sipe, 434-924-8775, lag3k@virginia.edu
Justin Smith, MD
- Withdrawn
Rush University, Department of Neurosurgery
Chicago, Illinois, 60612
- Recruiting
Medical City Spine Hospital - Southwest Scoliosis Institute
Dallas, Texas, 75243
Mona Hedra, MD, 214-663-5622, Mona.Hedra@HCAhealthcare.com
Richard Hostin, MD
- Recruiting
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, Colorado, 80128
Breton Line, BS, 303.762.3472, breton.line@gmail.com
Shay Bess, MD
- Recruiting
Duke University Health System
Durham, North Carolina, 27708
Ronald Pegues, ronald.pegues@duke.edu
Christopher I Shaffrey, MD
- Recruiting
University of Kansas Medical Center, Department of Orthopedic Surgery
Kansas City, Kansas, 66160
Dave Turkowitch, dturkowitch@kumc.edu
Brandon Carlson, MD
- Recruiting
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, 92037
Paulina de la Garza, 858-554-7124, delaGarza.Paulina@scrippshealth.org
Roslyn Kackman, Kackman.Roslyn@scrippshealth.org
- Recruiting
Leatherman Spine Center, Department of Orthopedic Surgery
Louisville, Kentucky, 40202
Morgan Brown, morgan.brown2@nortonhealthcare.org
Jeffrey Gum, MD
- Recruiting
Hospital for Special Surgery, Department of Orthopedic Surgery
New York, New York, 10003
Christopher Yoo, yooch@hss.edu
Han Jo Kim, MD
- Recruiting
New York University, Department of Orthopedic Surgery
New York, New York, 10003
Connie Maglaras, constance.maglaras@nyulangone.org
Themistocles Protopsaltis, MD
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Meghana Vulapalli, mv2748@cumc.columbia.edu
Daniel K Riew, MD
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
Lauren Puccio, pucciolm@upmc.edu
Thomas Buell, MD
- Active, not recruiting
University of California Davis, Department of Orthopedic Surgery
Sacramento, California, 95817
- Recruiting
University of California-San Francisco Medical Center
San Francisco, California, 94143
Adrian Fu, 925-202-9682, Adrian.Fu@ucsf.edu
Christopher Ames, MD
About this study
Official title: Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0
Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.
Read the detailed description
Adult cervical deformity (ACD) is an uncommon but potentially severely debilitating condition with a broad range of causes that include but are not limited to spondylosis, inflammatory arthropathy, trauma, infection, iatrogenic, neoplastic, congenital, and neuromuscular processes. In general, sagittal plane deformities typically produce kyphosis, and coronal plane deformities result in scoliosis. Cervical kyphotic deformities are most commonly encountered in the setting of prior surgical destabilization, while cervical scoliosis is most commonly associated with congenital and neuromuscular conditions.
Cervical kyphosis may be progressive and can result in neurological symptoms, including myelopathy. The most severe forms, such as those associated with spondylotic arthropathies, can produce "chin-on-chest" deformity, which can compromise horizontal gaze, swallowing, and breathing. Even in the absence of these conditions, cervical deformity is often associated with pain and functional disability. For adult thoracolumbar deformities, substantial efforts have been made to characterize clinical presentations, develop standardized classification systems, define optimal treatment approaches, describes operative complication rates, and to present structured clinical outcomes. However, despite the potential for profound impact of cervical deformity on function and health-related quality of life, there remains a remarkable paucity of high-quality studies that address these complex conditions.
Health professionals providing nonoperative and surgical care for these patients are left to make important treatment decisions based on a combination of personal experience, anecdotal experience of colleagues and experts, and relatively small, often single-surgeon or single-center, retrospective case reports or case series in the literature. Recent systematic reviews have high-lighted the lack of studies relevant to cervical deformity and have failed to identify any prospective studies.
The International Spine Study Group (ISSG) consists of orthopedic and neurological spine surgeons with a practice emphasis on spinal deformity patients. These surgeons, from 12 busy surgical centers, meet regularly to design and perform clinical research focused on spinal deformity, including successful prospective enrollment of more than 1,000 adult thoracolumbar deformity patients into the ISSG database. This group has a proven track record and regularly presents a substantial number of abstracts to the major spine meetings and has an extensive publication record.
The ISSG members have currently enrolled more than 150 patients into the first generation prospective cervical deformity database and have produced approximately 50 abstracts and more than 25 manuscripts to date with the resulting data. The group has learned extensively from this first-generation database, but there is much yet to learn, as the literature remains relatively sparse on the topic of adult cervical deformity. Based on what we have learned from the first generation database; we have substantially modified the inclusion criteria for this second generation database. In addition, several new outcomes measures and functional assessments will be collected at baseline and follow-up intervals as part of this current proposal.
The resources of the ISSG offer an unprecedented opportunity to create a prospectively collected multicenter database of cervical deformity patients that includes standardized health-related quality of life measures at baseline and regular follow-up, clinical and surgical parameters, and complications. The database and questionnaires have been carefully redesigned based on what we have learned in order to better collect data that will help to clarify many of the unresolved issues that are important for the care of cervical deformity patients. This project has substantial potential to significantly impact the field of cervical deformity and the care of deformity patients beyond what we have already been able to accomplish based on the first generation cervical deformity database. Herein we propose the second iteration for this project that promises to further advance our evolving understanding of these complex deformities.
- Conditions
- Cervical Deformity
- Being tested
- Surgical intervention
- 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.
Surgical interventionProcedure or surgery
Surgical interventions 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. Diagnosis of cervical deformity- must meet one or more of the following criteria:
* C2-C7 sagittal kyphosis (Cobb > 15o)
* T1S-CL > 35o
* Segmental cervical kyphosis > 10o between any 2 vertebra between C2-T1 or > 15o across any 3 vertebra between C2-T1
* Cervical scoliosis > 10o (Cobb angle must include end vertebra within the cervical spine)
* C2-C7 SVA > 4cm
* McGregor's slope > 20 degrees or CBVA > 25 degrees
3. Plan for surgical correction of cervical deformity in the next 6 months Receives: Procedure: Surgical intervention |
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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Neck Disability Index (NDI)
Patient reported neck disability tool
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Veterans RAND 12 Item Health Survey (VR-12)
Patient reported outcome
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
Computer adaptive PROs
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
Computer adaptive PROs
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference
Computer adaptive PROs
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function
Computer adaptive PROs
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (Role)
Computer adaptive PROs
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)
Computer adaptive PROs
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Secondary outcomes (6)
EAT-10
Measures swallowing difficulties as reported by the patient.
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Voice Handicap Index (VHI-10)
Measures voice handicap as reported by the patient.
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Adverse evnts
Any adverse events occurring \& meeting study established reporting criteria
Measured: 3 months and 1, 2, 5 & 10 year post treatment
Edmonton Frail Scale
Frailty scale from 0 to 17 where the higher the score the more frail the patient
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
CHSF Frail Scale
Clinical Frailty Scale from 1 to 9 where the higher the score, the more frail the patient
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Dynamometer Hand Grip Strength test
With patient seated, patient will squeeze dynamometer as hard as he/she can with each hand.
Measured: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 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 posted11 Dec 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2030 (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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Spine Study Group Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes, Orthofix Inc.
- Responsible party
- Sponsor
- Investigators
- Justin Smith, MD, Principal investigator, University of Virginia, Department of NeurosurgeryChristopher Ames, MD, Principal investigator, University of California, San Francisco, Department on NeurosurgeryChristopher I Shaffrey, MD, Principal investigator, Duke University, Departments of Neurosurgery and Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194996
- Sponsor's protocol ID
- 2131
- Acronym
- PCD 2
- Status last verified
- Feb 2026
- First submitted
- 25 Nov 2019
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0
- ClinicalTrials.gov ID
- NCT04194996
- Acronym / sponsor ID
- PCD 2 / 2131
- Conditions
- Cervical Deformity
- Keywords
- Cervical deformity, Kyphosis, Scoliosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- International Spine Study Group FoundationUniversity, hospital or other
- Collaborators
- DePuy Synthes, Orthofix Inc.
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 11 Dec 2019 (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 outcomes of surgically treated patients with adult cervical spinal deformity.
Detailed description
Adult cervical deformity (ACD) is an uncommon but potentially severely debilitating condition with a broad range of causes that include but are not limited to spondylosis, inflammatory arthropathy, trauma, infection, iatrogenic, neoplastic, congenital, and neuromuscular processes. In general, sagittal plane deformities typically produce kyphosis, and coronal plane deformities result in scoliosis. Cervical kyphotic deformities are most commonly encountered in the setting of prior surgical destabilization, while cervical scoliosis is most commonly associated with congenital and neuromuscular conditions.
Cervical kyphosis may be progressive and can result in neurological symptoms, including myelopathy. The most severe forms, such as those associated with spondylotic arthropathies, can produce "chin-on-chest" deformity, which can compromise horizontal gaze, swallowing, and breathing. Even in the absence of these conditions, cervical deformity is often associated with pain and functional disability. For adult thoracolumbar deformities, substantial efforts have been made to characterize clinical presentations, develop standardized classification systems, define optimal treatment approaches, describes operative complication rates, and to present structured clinical outcomes. However, despite the potential for profound impact of cervical deformity on function and health-related quality of life, there remains a remarkable paucity of high-quality studies that address these complex conditions.
Health professionals providing nonoperative and surgical care for these patients are left to make important treatment decisions based on a combination of personal experience, anecdotal experience of colleagues and experts, and relatively small, often single-surgeon or single-center, retrospective case reports or case series in the literature. Recent systematic reviews have high-lighted the lack of studies relevant to cervical deformity and have failed to identify any prospective studies.
The International Spine Study Group (ISSG) consists of orthopedic and neurological spine surgeons with a practice emphasis on spinal deformity patients. These surgeons, from 12 busy surgical centers, meet regularly to design and perform clinical research focused on spinal deformity, including successful prospective enrollment of more than 1,000 adult thoracolumbar deformity patients into the ISSG database. This group has a proven track record and regularly presents a substantial number of abstracts to the major spine meetings and has an extensive publication record.
The ISSG members have currently enrolled more than 150 patients into the first generation prospective cervical deformity database and have produced approximately 50 abstracts and more than 25 manuscripts to date with the resulting data. The group has learned extensively from this first-generation database, but there is much yet to learn, as the literature remains relatively sparse on the topic of adult cervical deformity. Based on what we have learned from the first generation database; we have substantially modified the inclusion criteria for this second generation database. In addition, several new outcomes measures and functional assessments will be collected at baseline and follow-up intervals as part of this current proposal.
The resources of the ISSG offer an unprecedented opportunity to create a prospectively collected multicenter database of cervical deformity patients that includes standardized health-related quality of life measures at baseline and regular follow-up, clinical and surgical parameters, and complications. The database and questionnaires have been carefully redesigned based on what we have learned in order to better collect data that will help to clarify many of the unresolved issues that are important for the care of cervical deformity patients. This project has substantial potential to significantly impact the field of cervical deformity and the care of deformity patients beyond what we have already been able to accomplish based on the first generation cervical deformity database. Herein we propose the second iteration for this project that promises to further advance our evolving understanding of these complex deformities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operative | – | Procedure: Surgical interventionInclusion criteria: 1. ≥18 years old at time of treatment 2. Diagnosis of cervical deformity- must meet one or more of the following criteria: * C2-C7 sagittal kyphosis (Cobb > 15o) * T1S-CL > 35o * Segmental cervical kyphosis > 10o between any 2 vertebra between C2-T1 or > 15o across any 3 vertebra between C2-T1 * Cervical scoliosis > 10o (Cobb angle must include end vertebra within the cervical spine) * C2-C7 SVA > 4cm * McGregor's slope > 20 degrees or CBVA > 25 degrees 3. Plan for surgical correction of cervical deformity in the next 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spine Surgeon Clinic
Key inclusion criteria (14 listed)
- ≥18 years old at time of treatment
- Diagnosis of cervical deformity- must meet one or more of the following 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
- Upright AP/Lateral entire spine (EOS or 36")
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 |
|---|---|---|
| Surgical interventionSurgical interventions will be patient specified by treating surgeon. | Procedure or surgery | Operative |
Primary outcome
Pain Numeric rating scale (NRS) - Headaches
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Patient reported neck disability tool
Veterans RAND 12 Item Health Survey (VR-12)
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Patient reported outcome
Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PROs
Patient-Reported Outcome Measurement Information System (PROMIS) - Depression
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PROs
Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PROs
Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PROs
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (Role)
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PROs
Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Computer adaptive PROs
Spine Radiographs
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Voice Handicap Index (VHI-10)
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Adverse evnts
Time frame: 3 months and 1, 2, 5 & 10 year post treatment
Edmonton Frail Scale
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
CHSF Frail Scale
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Dynamometer Hand Grip Strength test
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 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.
Ray Pinteric contact
Justin Smith, MD principal investigator
University of Virginia, Department of Neurosurgery
Christopher Ames, MD principal investigator
University of California, San Francisco, Department on Neurosurgery
Christopher I Shaffrey, MD principal investigator
Duke University, Departments of Neurosurgery and Orthopaedic Surgery
16 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 16 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 14 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: looking for participants now, 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 16 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?
Contact Christine Baldus, MS (6184444130, baldusc@wustl.edu), or a site near the patient. 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 3 months, 6 months and 1, 2, 5 & 10 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.