Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2033-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity

NCT01588054

Cervical Deformity Kyphosis Scoliosis

COMPLETED

Evaluation of Symphony™ Posterior Cervical System for Surgical Treatment of Adult Cervical Deformity

NCT04912674

Cervical Deformity

RECRUITING

Cervical I/F Cage for Anterior Cervical Fusion

NCT00215293

Cervical Intervertebral Disc Degeneration

COMPLETED PHASE3

Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers

NCT04041583

Cervical Fusion

RECRUITING

Posterior Cervical Fixation Study

NCT04770571

Degenerative Disc Disease Craniocervical Injuries Cervical Radiculopathy +6 more

ENROLLING_BY_INVITATION

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Deformity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Surgical intervention

Intervention Type PROCEDURE

Surgical interventions will be patient specified by treating surgeon.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgical intervention

Surgical interventions will be patient specified by treating surgeon.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ≥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)
* C2-C7 SVA \> 4cm
* McGregor's slope \> 20 degrees or CBVA \> 25 degrees
* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years