NCT03062657

An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7. The information obtained from this clinical investigation will be used to support the post market surveillance for a PMA supplement for the PRESTIGE LP™ Cervical Disc implanted at two contiguous levels.

Conditions

• Cervical Degenerative Disc Disease
• Radiculopathy
• Myelopathy

Interventions

Type	Name	Description
DEVICE	PRESTIGE LP™ Cervical Disc	The PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels.

Timeline

• Start date: 2018-06-06
• Primary completion: 2023-01-27
• Completion: 2023-01-27
• First posted: 2017-02-23
• Last updated: 2024-04-05
• Results posted: 2024-03-21

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study