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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Lumbar Disc Disease
• Intervention / Treatment: Device: SIGNUS MOBIS PEEK Cage; Device: SIGNUS MOBIS II ST Cage

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • East Syracuse, New York, United States, 13057
      • Upstate Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion rates	Lumbar fusion demonstrated by radiographic evidence based on plain radiographs, and CT Scans	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subsidence	disc height demonstrated by radiographic evidence based on plain radiographs, and CT Scans	24 Months
Patient Reported Outcomes: Visual Analog Scale (VAS)	Comparison of pre-operative to post-operative evaluations	Through 24 Months
Patient Reported Outcomes: Oswestry Disability Index	Comparison of pre-operative to post-operative evaluations	Through 24 Months
Patient Reported Outcomes: Evaluations of Quality of Life (QOL) by the EQ-5D-5L	Comparison of pre-operative to post-operative evaluations	Through 24 Months

Collaborators and Investigators

• Sponsor: Signus Medizintechnik GmbH
• Investigators: Principal Investigator: William F. Lavelle, MD, Upstate Orthopedics

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): November 1, 2018
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: July 18, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (ESTIMATE): August 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Intervertebral Disc Degeneration; Lumbar Spinal Disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: 01MOBIS_US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO