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| Name | Class |
|---|---|
| DePuy Synthes | INDUSTRY |
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Multi-center, prospective, non-randomized study to evaluate Symphonyâ„¢ Posterior Cervical System in the setting of surgical treatment of adult cervical deformity.
Specific Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operative | Inclusion Criteria:
Exclusion Criteria:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symphony OCT System | Device | Surgical intervention will be patient specified by treating surgeon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Numeric rating scale (NRS) - Headaches | Self reported pain in Head where 0=no pain/10=severe pain | 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 | 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 | 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 | 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 | Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up |
| Neck Disability Index (NDI) | Patient reported neck disability tool | 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 | Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| EAT-10 | Measures swallowing difficulties as reported by the patient. | 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. |
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Inclusion Criteria:
≥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
Exclusion Criteria:
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Adult cervical deformity patients from spine surgeon clinic
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| Name | Affiliation | Role |
|---|---|---|
| Justin Smith, MD, PhD | University of Virginia | Principal Investigator |
| Christopher Shaffrey, MD | Duke University | Principal Investigator |
| Shay Bess, MD | Denver Int'l Spine Center, Rocky Mountain Hospital for Children & Presbyterian St. Luke's MC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis | Sacramento | California | 95817 | United States | ||
| Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center |
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| Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety | Computer adaptive PROs | 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 | 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 | 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 | 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 | 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 | 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 | 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. | Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up |
| 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 | 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 | 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 | 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. | Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up |
| Denver |
| Colorado |
| 80128 |
| United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15219 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| ID | Term |
|---|---|
| D007738 | Kyphosis |
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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