An observational study in Cervical Deformity, sponsored by International Spine Study Group Foundation. Recruiting at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by International Spine Study Group Foundation · Observational
Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.
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.
132 studies on the registry are indexed under Kyphosis; 31 are open to participants now.
This study's planned enrollment of 200 is above the median of 62 across 45 observational studies indexed under Kyphosis.
Browse Kyphosis studies →International Spine Study Group Foundation is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Spine Surgeon Clinic
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of cervical deformity- must meet one or more of the following criteria:
Exclusion Criteria:
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
Procedure: Surgical intervention
Surgical interventions will be patient specified by treating surgeon.
Pain Numeric rating scale (NRS) - Headaches
Self-reported pain in Head where 0=no pain/10=severe pain
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
EAT-10
Measures swallowing difficulties as reported by the patient.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2019 (actual). Primary completion is estimated for Dec 2027, 100 months after the start.
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International Spine Study Group Foundation