NCT02852187

Single Center Study Comparing MOBIS II ST vs MOBIS PEEK

Prospective, Randomized, Data Registry Study of MOBIS II Structural Titanium (ST) Interbody Cage Compared to MOBIS Peek Cage for the Treatment of Spondylolisthesis and Degenerative Disc Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Signus Medizintechnik GmbH · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

Prospective randomized clinical study comparing SIGNUS MOBIS PEEK vs SIGNUS MOBIS II ST in patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1

Detailed description

The protocol includes skeletally mature patients both male and female, 18 to 89 years old, with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients may also have up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patient should have completed at least six (6) months of non-operative treatment. Patients may have had a previous non-fusion surgery at the involved spinal level(s) and will be followed clinically up to two years.

Conditions

• Lumbar Disc Disease

Interventions

Type	Name	Description
DEVICE	SIGNUS MOBIS PEEK Cage	Lumbar Interbody Fusion
DEVICE	SIGNUS MOBIS II ST Cage	Lumbar Interbody Fusion

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2016-08-02
• Last updated: 2020-03-19

Locations

1 site across 1 country: United States