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Single Center Study Comparing MOBIS II ST vs MOBIS PEEK (MOBIS_US)

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ClinicalTrials.gov Identifier: NCT02852187
Recruitment Status : Terminated (Lack of recruitement)
First Posted : August 2, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Signus Medizintechnik GmbH

Brief 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

Condition or disease Intervention/treatment Phase
Lumbar Disc Disease Device: SIGNUS MOBIS PEEK Cage Device: SIGNUS MOBIS II ST Cage Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MOBIS PEEK
Transforaminal Lumbar Interbody Fusion (TLIF) with the SIGNUS MOBIS PEEK Cage
Device: SIGNUS MOBIS PEEK Cage
Lumbar Interbody Fusion

Active Comparator: MOBIS II ST
Transforaminal Lumbar Interbody Fusion (TLIF) with the SIGNUS MOBIS II ST Cage
Device: SIGNUS MOBIS II ST Cage
Lumbar Interbody Fusion




Primary Outcome Measures :
  1. Fusion rates [ Time Frame: 24 Months ]
    Lumbar fusion demonstrated by radiographic evidence based on plain radiographs, and CT Scans


Secondary Outcome Measures :
  1. Subsidence [ Time Frame: 24 Months ]
    disc height demonstrated by radiographic evidence based on plain radiographs, and CT Scans

  2. Patient Reported Outcomes: Visual Analog Scale (VAS) [ Time Frame: Through 24 Months ]
    Comparison of pre-operative to post-operative evaluations

  3. Patient Reported Outcomes: Oswestry Disability Index [ Time Frame: Through 24 Months ]
    Comparison of pre-operative to post-operative evaluations

  4. Patient Reported Outcomes: Evaluations of Quality of Life (QOL) by the EQ-5D-5L [ Time Frame: Through 24 Months ]
    Comparison of pre-operative to post-operative evaluations



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  11. The patient has symptomatic fibrous arachnoiditis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852187


Locations
United States, New York
Upstate Orthopedics
East Syracuse, New York, United States, 13057
Sponsors and Collaborators
Signus Medizintechnik GmbH
Investigators
Principal Investigator: William F. Lavelle, MD Upstate Orthopedics

Responsible Party: Signus Medizintechnik GmbH
ClinicalTrials.gov Identifier: NCT02852187     History of Changes
Other Study ID Numbers: 01MOBIS_US
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Signus Medizintechnik GmbH:
Intervertebral Disc Degeneration
Lumbar Spinal Disease