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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInternational Spine Study Group Foundation

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old at time of treatment

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

Disqualifiers

Active spine tumor or infection

Deformity due to acute trauma

Unwilling to provide consent or to complete study forms

Prisoner

Trial population

Spine Surgeon Clinic

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Surgical intervention

    Procedure/Surgery

    Surgical interventions will be patient specified by treating surgeon.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Operative1 intervention

Trial outcomes

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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 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 3 months, 6 months and 1, 2, 5 & 10 year follow-up

Secondary outcomes

1

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
2

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
3

Adverse evnts

Any adverse events occurring \& meeting study established reporting criteria

Time frame
3 months and 1, 2, 5 & 10 year post treatment
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 3 months, 6 months and 1, 2, 5 & 10 year follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

International Spine Study Group Foundation

Lead sponsor

DePuy Synthes

Collaborator

Orthofix Inc.

Collaborator