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

Browse trials for

• Kyphosis 132
• Scoliosis 660

Keywords

• Cervical deformity
• Kyphosis
• Scoliosis

Kyphosis

132 studies on the registry are indexed under Kyphosis; 31 are open to participants now.

This study's planned enrollment of 100 is above the median of 62 across 45 observational studies indexed under Kyphosis.

Lead sponsor

International Spine Study Group Foundation is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Study population

Groups and cohorts

• Operative

  Inclusion Criteria: 1. ≥18 years old at time of treatment 2. 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: 1. Loss of cervical lordosis (≤ 0° cervical lordosis C2-7) 2. ≥ 5° of kyphosis across any 1 or 2 cervical segments 3. ≥ 10° of cervical scoliosis 4. C2-C7 SVA ≥ 4cm 5. T1 Slope minus Cervical Lordosis ≥ 20° 6. Grade I or greater Spondylolisthesis at any segment C1-T1 7. Horizontal Gaze ≤ 0 or ≥ 11 3. Plan for surgical correction of cervical deformity in the next 6 months 4. Willing to provide consent and complete study forms at baseline and follow-up intervals Exclusion Criteria: 1. Active spine tumor or infection 2. Deformity due to acute trauma 3. Unwilling to provide consent or to complete study forms 4. Prisoner 5. Pregnant or immediate plans to get pregnant

  Device: Symphony OCT System

Interventions

• DeviceSymphony OCT System

  Surgical intervention will be patient specified by treating surgeon.

Primary outcomes

1. Pain Numeric rating scale (NRS) - Headaches

   Self reported pain in Head where 0=no pain/10=severe pain

   Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

2. Pain Numeric rating scale (NRS) - Neck

   Self-reported pain in Neck where 0=no pain/10=severe pain

   Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

3. 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 6 weeks, 6 months, and 1 & 2 year follow-up

4. 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 6 weeks, 6 months, and 1 & 2 year follow-up

5. Pain Numeric rating scale (NRS) - Back

   Self-reported pain in Back where 0=no pain/10=severe pain

   Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

6. Neck Disability Index (NDI)

   Patient reported neck disability tool

   Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

7. Veterans RAND 12 Item Health Survey (VR-12)

   Patient reported outcome

   Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

8. Patient-Reported Outcome Measurement Information System (PROMIS) - Anxiety

   Computer adaptive PROs

   Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

9. Patient-Reported Outcome Measurement Information System (PROMIS) - Depression

   Computer adaptive PROs

   Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

10. Patient-Reported Outcome Measurement Information System (PROMIS) - Pain Interference

    Computer adaptive PROs

    Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

11. Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function

    Computer adaptive PROs

    Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

12. Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (Role)

    Computer adaptive PROs

    Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

13. Patient-Reported Outcome Measurement Information System (PROMIS) - Social Satisfaction (DSA)

    Computer adaptive PROs

    Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

14. 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 6 weeks, 6 months, and 1 & 2 year follow-up

15. 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 6 weeks, 6 months, and 1 & 2 year follow-up

Secondary outcomes

1. EAT-10

   Measures swallowing difficulties as reported by the patient.

   Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

2. Voice Handicap Index (VHI-10)

   Measures voice handicap as reported by the patient.

   Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

3. Adverse events

   Any adverse events that occur during study participation \& meeting study established reporting criteria

   Time frame: 6 weeks, 1 year, and 2 years

4. 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 6 weeks, 6 months, and 1 & 2 year follow-up

5. CHSA 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 6 weeks, 6 months, and 1 & 2 year follow-up

6. Dynamometer Hand Grip Strength test

   With patient seated, patient will squeeze the dynamometer as hard as he/she can with each hand.

   Time frame: Change from Preop to 6 weeks, 6 months, and 1 & 2 year follow-up

Individual participant data

Plan to share: No