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

Conditions

• Cervical Deformity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Surgical intervention — PROCEDURE
  Surgical interventions will be patient specified by treating surgeon.

Study Details

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

Key Dates

Start date

Aug 1, 2019

Status verified

Feb 2026

Primary completion

Dec 31, 2027

Completion

Jul 31, 2030

Study Design

Enrollment

200 participants (estimated)

Arms

• Arm: Operative
  Inclusion criteria: 1. ≥18 years old at time of treatment 2. Diagnosis of cervical deformity- must meet one or more of the following criteria: * C2-C7 sagittal kyphosis (Cobb \> 15o) * T1S-CL \> 35o * Segmental cervical kyphosis \> 10o between any 2 vertebra between C2-T1 or \> 15o across any 3 vertebra between C2-T1 * Cervical scoliosis \> 10o (Cobb angle must include end vertebra within the cervical spine) * C2-C7 SVA \> 4cm * McGregor's slope \> 20 degrees or CBVA \> 25 degrees 3. Plan for surgical correction of cervical deformity in the next 6 months

Primary Outcome Measure

Pain Numeric rating scale (NRS) - Headaches [ Time Frame: Change from Preop to 3 months, 6 months and 1, 2, 5 & 10 year follow-up ]

Central Contacts

• Christine Baldus, MS
  6184444130
  [email protected]
• Ray Pinteric
  [email protected]

Locations (16)

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