Lumbar Disc DiseaseMOBIS_USNCT02852187
Single Center Study Comparing MOBIS II ST vs MOBIS PEEK
A study testing SIGNUS MOBIS PEEK Cage and SIGNUS MOBIS II ST Cage in people with Lumbar Disc Disease, run by Signus Medizintechnik GmbH at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Lumbar Disc Disease
- What is being tested?
- SIGNUS MOBIS PEEK Cage and SIGNUS MOBIS II ST Cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- SIGNUS MOBIS PEEK Cage, SIGNUS MOBIS II ST Cage
- Keywords
- Intervertebral Disc Degeneration, Lumbar Spinal Disease
- Medical subject headings
- Intervertebral disc disease, Intervertebral Disc Degeneration, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIGNUS MOBIS PEEK CageDevice
Lumbar Interbody Fusion
SIGNUS MOBIS II ST CageDevice
Lumbar Interbody Fusion
| Study group | Role | What they receive |
|---|---|---|
| MOBIS PEEK | Active comparator | Transforaminal Lumbar Interbody Fusion (TLIF) with the SIGNUS MOBIS PEEK Cage Receives: Device: SIGNUS MOBIS PEEK Cage |
| MOBIS II ST | Active comparator | Transforaminal Lumbar Interbody Fusion (TLIF) with the SIGNUS MOBIS II ST Cage Receives: Device: SIGNUS MOBIS II ST Cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion rates
Lumbar fusion demonstrated by radiographic evidence based on plain radiographs, and CT Scans
Measured: 24 Months
Secondary outcomes (4)
Subsidence
disc height demonstrated by radiographic evidence based on plain radiographs, and CT Scans
Measured: 24 Months
Patient Reported Outcomes: Visual Analog Scale (VAS)
Comparison of pre-operative to post-operative evaluations
Measured: Through 24 Months
Patient Reported Outcomes: Oswestry Disability Index
Comparison of pre-operative to post-operative evaluations
Measured: 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
Measured: Through 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2018
- Study completionNov 2018
Why it stopped: Lack of recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Signus Medizintechnik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William F. Lavelle, MD, Principal investigator, Upstate Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02852187
- Sponsor's protocol ID
- 01MOBIS_US
- Acronym
- MOBIS_US
- Status last verified
- Mar 2020
- First submitted
- 18 Jul 2016
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02852187
- Acronym / sponsor ID
- MOBIS_US / 01MOBIS_US
- Conditions
- Lumbar Disc Disease
- Keywords
- Intervertebral Disc Degeneration, Lumbar Spinal Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of recruitement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Signus Medizintechnik GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 2 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOBIS PEEK | Active comparator | Device: SIGNUS MOBIS PEEK CageTransforaminal Lumbar Interbody Fusion (TLIF) with the SIGNUS MOBIS PEEK Cage |
| MOBIS II ST | Active comparator | Device: SIGNUS MOBIS II ST CageTransforaminal Lumbar Interbody Fusion (TLIF) with the SIGNUS MOBIS II ST Cage |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIGNUS MOBIS PEEK CageLumbar Interbody Fusion | Device | MOBIS PEEK |
| SIGNUS MOBIS II ST CageLumbar Interbody Fusion | Device | MOBIS II ST |
Primary outcome
Fusion rates
Time frame: 24 Months
Lumbar fusion demonstrated by radiographic evidence based on plain radiographs, and CT Scans
4 secondary outcomes
Subsidence
Time frame: 24 Months
Patient Reported Outcomes: Visual Analog Scale (VAS)
Time frame: Through 24 Months
Patient Reported Outcomes: Oswestry Disability Index
Time frame: Through 24 Months
Patient Reported Outcomes: Evaluations of Quality of Life (QOL) by the EQ-5D-5L
Time frame: Through 24 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William F. Lavelle, MD principal investigator
Upstate Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIGNUS MOBIS PEEK Cage and SIGNUS MOBIS II ST Cage in people with Lumbar Disc Disease, run by Signus Medizintechnik GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion rates (time frame: 24 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.