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

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 design

Treatments tested in this trial

  • Surgical intervention

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

International Spine Study Group Foundation

Lead sponsor

DePuy Synthes

Collaborator

Orthofix Inc.

Collaborator