Single Center Study Comparing MOBIS II ST vs MOBIS PEEK

Withdrawn before enrolling · Not applicable

Conditions studied: Lumbar Disc Disease

In brief

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

Key facts

Study ID

NCT02852187

Run by

Signus Medizintechnik GmbH

People needed

0

Starts

2016-07-01

Expected to finish

2018-11-01

Last updated by the study team

2020-03-19

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient has symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1.
• The patient has documented conservative (non-operative) treatment for at least 6 months.
• The patient has a VAS back pain of ≥ 60 mm.
• The patient has an ODI ≥ 40%.
• The patient is at least 18 years of age and skeletally mature.
• The general condition of the patient is appropriate for surgery, as evaluated by the Investigator.
• The patient is willing and able to comply with study requirements.
• The patient has agreed to participate in the study.

You may not qualify if…

• The patient has undergone any prior spinal fusion surgery at the proposed treatment level(s).
• The patient has osteoporosis or severe osteopenia as determined by the Investigator. A clinical SCORE calculator may be utilized for females over 40 years of age.
• The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s).
• The patient has diffuse multilevel neoplastic disease such that no adjacent normal segments exist for engagement or instrumentation.
• The patient has an active infection.
• The patient is pregnant or is planning on becoming pregnant in the next two years.
• The patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues.
• The patient has a known allergy to polyether ether ketone (PEEK), stainless steel or tantalum/titanium.
• The patient is currently enrolled in an investigational spine study.
• The patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease.
• The patient has symptomatic fibrous arachnoiditis

Where it is running

• Upstate Orthopedics — East Syracuse, New York, United States

Full record on ClinicalTrials.gov

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