NCT02075554

Study of an Expandable Interbody Device for the Lumbar Spine

Efficacy and Safety of Expandable Spacer in the Treatment of Degenerative Disc Disease Using the Minimally Invasive Transforaminal Lumbar Interbody Fusion Surgical Approach

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Globus Medical Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from patients in this 2 year follow-up clinical study.

Detailed description

Patients will be followed-up at 3weeks, 6 weeks, 3 months, 6 months, 12 and 24 months with X-rays and questionnaires to determine their satisfaction, healing, fusion and return to work status

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
DEVICE	CALIBER	Expandable interbody spacer

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-11-01
• Completion: 2017-02-01
• First posted: 2014-03-03
• Last updated: 2021-02-03
• Results posted: 2021-02-03

Locations

2 sites across 1 country: United States