Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System

Zimmer Biomet

Status: Completed

Conditions: Spinal Deformity

Treatments: Procedure: Surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT01220505

CS-058

Details and patient eligibility

About

The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity Correction System.

Full description

The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System & Trivium 3D Spinal Deformity Correction System. We have extended the study tol collect further outcomes data at the 12 month time point.

Enrollment: 66 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 200 subjects at 10 clinical centers.
• All subjects undergoing spinal fusion surgery between the levels of T1- Ilium (Thoracic 1 to Ilium)
• All subjects are skeletally mature with spinal deformity.
• Risser score must be ≥ 3.
• Subjects or their representative must be willing and able to give informed consent and assent (if applicable).
• Subjects who do not meet any of the following contraindications: spinal infection or inflammation, morbid obesity, mental illness, alcoholism, drug abuse, pregnancy, metal sensitivity, foreign body sensitivity, patients with inadequate tissue coverage over the operative site, open wounds local to the operative area, any case not described in the specific indications

Exclusion criteria

• Any subject who does not meet the inclusion criteria