Loading clinical trials...

Single Center Study Comparing MOBIS II ST vs MOBIS PEEK | Clinical Trials | Clareo Health

WITHDRAWNNA

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

NCT02852187•Signus Medizintechnik GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 89 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. The patient has undergone any prior spinal fusion surgery at the proposed treatment level(s).
•2. 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.
•3. The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s).
•4. The patient has diffuse multilevel neoplastic disease such that no adjacent normal segments exist for engagement or instrumentation.
•5. The patient has an active infection.
•6. The patient is pregnant or is planning on becoming pregnant in the next two years.
•7. The patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues.
•8. The patient has a known allergy to polyether ether ketone (PEEK), stainless steel or tantalum/titanium.
•9. The patient is currently enrolled in an investigational spine study.
•10. The patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease.
+1 more criteria

Locations (1)

Upstate Orthopedics

East Syracuse, New York, United States

Key Dates

Start Date

July 1, 2016

Primary Completion Date

November 1, 2018

Completion Date

November 1, 2018

Last Updated

March 19, 2020

Conditions

Lumbar Disc Disease

Interventions

SIGNUS MOBIS PEEK Cage

DEVICE

SIGNUS MOBIS II ST Cage

DEVICE

Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis

NCT04641039

Lumbar Disc Disease

View study

COMPLETED

Advanced XLIF Monitoring Pilot Study

NCT02192112

Degenerative Lumbar Disc Disease

View study

COMPLETED

Study of the Long-Term Outcomes of Posterior Spinal Fixation With the Karma Device

NCT04984213

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Single Center Study Comparing MOBIS II ST vs MOBIS PEEK

Inclusion Criteria

Exclusion Criteria

Postoperative Scar in the Control Excess of Mobility Induced by Annulus Removal on Inserting a Lumbar Disc Prosthesis

Advanced XLIF Monitoring Pilot Study

Study of the Long-Term Outcomes of Posterior Spinal Fixation With the Karma Device

Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease

Effects of Kinesio Taping on Pain, Endurance, Proprioception, Mobility and Disability in Lumbar Disc Herniation

The Six-Minute Walking Test (6MWT) as a Measure of Functional Impairment in Lumbar Degenerate Disc Disease.