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

Cervical Deformity Clinical Trial

— PCD 2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194996
• Other study ID #: 2131
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: July 31, 2033

Study information

• Verified date: March 2024
• Source: International Spine Study Group Foundation
• Contact: Christine Baldus, MS
• Phone: 6184444130
• Email: baldusc[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2033
• Est. primary completion date: December 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Deformity
• Congenital Abnormalities

Intervention

Procedure:
• Surgical intervention
Surgical interventions will be patient specified by treating surgeon.

Locations

Country	Name	City	State
United States	University of Michigan, Department of Neurosurgery	Ann Arbor	Michigan
United States	Johns Hopkins University, Department of Neurological Surgery	Baltimore	Maryland
United States	University of Virginia	Charlottesville	Virginia
United States	Rush University, Department of Neurosurgery	Chicago	Illinois
United States	Medical City Spine Hospital - Southwest Scoliosis Institute	Dallas	Texas
United States	Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center	Denver	Colorado
United States	Duke University Health System	Durham	North Carolina
United States	University of Kansas Medical Center, Department of Orthopedic Surgery	Kansas City	Kansas
United States	Shiley Center for Orthopaedic Research and Education at Scripps Clinic	La Jolla	California
United States	Leatherman Spine Center, Department of Orthopedic Surgery	Louisville	Kentucky
United States	Columbia University Medical Center	New York	New York
United States	Hospital for Special Surgery, Department of Orthopedic Surgery	New York	New York
United States	New York University, Department of Orthopedic Surgery	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of California Davis, Department of Orthopedic Surgery	Sacramento	California
United States	Washington University, Department of Orthopedic Surgery	Saint Louis	Missouri
United States	University of California-San Francisco Medical Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
International Spine Study Group Foundation	DePuy Synthes, Orthofix Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Numeric rating scale (NRS) - Headaches	Self-reported pain in Head where 0=no pain/10=severe pain	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	Pain Numeric rating scale (NRS) - Neck	Self-reported pain in Neck where 0=no pain/10=severe pain	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	Pain Numeric rating scale (NRS) - Upper extremity	Self-reported pain in Arms where 0=no pain/10=severe pain	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	Pain Numeric rating scale (NRS) - Lower extremity	Self-reported pain in Legs where 0=no pain/10=severe pain	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	Pain Numeric rating scale (NRS) - Back	Self-reported pain in Back where 0=no pain/10=severe pain	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	Neck Disability Index (NDI)	Patient reported neck disability tool	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	Veterans RAND 12 Item Health Survey (VR-12)	Patient reported outcome	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety	Computer adaptive PROs	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Depression	Computer adaptive PROs	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference	Computer adaptive PROs	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function	Computer adaptive PROs	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (Role)	Computer adaptive PROs	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)	Computer adaptive PROs	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	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.	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Primary	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.	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Secondary	EAT-10	Measures swallowing difficulties as reported by the patient.	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Secondary	Voice Handicap Index (VHI-10)	Measures voice handicap as reported by the patient.	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Secondary	Adverse evnts	Any adverse events occurring & meeting study established reporting criteria	3 months and 1, 2, 5 & 10 year post treatment
Secondary	Edmonton Frail Scale	Frailty scale from 0 to 17 where the higher the score the more frail the patient	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Secondary	CHSF Frail Scale	Clinical Frailty Scale from 1 to 9 where the higher the score, the more frail the patient	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up
Secondary	Dynamometer Hand Grip Strength test	With patient seated, patient will squeeze dynamometer as hard as he/she can with each hand.	Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up