Spine SurgeryBalanCNCT02551302
"Efficacy of Hybrid Systems ("Topping Off") Versus Rigid Spinal Fusion in Lumbar Fusion Surgery: A Dual-center, Prospective, Randomized Pilot Study ("CD Horizon BalanC")"
A study testing Solera™ Medtronic and CD HORIZON BalanC™ Medtronic in people with Spine Surgery, run by University of Cologne.
Trial summary
Effectiveness of hybrid systems ("topping off") compared to rigid spondylodesis in fusion surgery of the lumbar spine: A prospective, randomized, bicentric pilot study ("CD HORIZON BalanC™) Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Spine Surgery
- What is being tested?
- Solera™ Medtronic and CD HORIZON BalanC™ Medtronic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Dec 2017
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Legal capacity
- Age ≥ 30 years
- Indication for monosegmental lumbar spine fusion (PLIF or "topping-off ") L2-S1 with osteochondrosis Modic grades I-III [20][21][22] or spondylolisthesis Meyerding grades I-III.
- Radiologic signs of degeneration in the adjacent segment of the intended fusion without signs of instability
Who cannot join
- Motor deficit
- Cauda equina syndrome
- Previous surgical intervention of the lumbar spine
- Relevant peripheral neuropathy
- Acute denervation subsequent to a radiculopathy
- Scoliosis with Cobb angle greater than 25°
Show all 31Show fewer
- Spondylolisthesis > Meyerding grade III
- Radiologic signs of degeneration in the adjacent segment of the intended fusion with signs of instability (for definition, see inclusion criteria)
- No radiologic signs of degeneration in the adjacent segment of the intended fusion (for definition, see inclusion criteria)
- Radiologic signs of degeneration in the adjacent segment of the intended fusion with >Fujiwara grade II [15] or >Pfirrmann grade IV [14]
- Signs of instability in any lumbar spine segment other than that undergoing fusion
- General contraindication for elective lumbar spine surgery
- Pathologic fracture
- Osteoporosis with pathologic fracture
- Active systemic infection
- Rheumatic disease
- Disease of bone metabolism (e.g. Paget's Disease)
- Bone metastasis
- Local infection focus lumbar spine
- Seizure disorder
- Chronic ischemia Fontaine classification IIb-IV
- Severe heart insufficiency (NYHA III-IV)
- Blood coagulation disorder or blood thinning therapy
- Cortisone intake more than one month in the last 12 months before randomization
- Simultaneous participation in another clinical trial in the 30 days before randomization
- Known allergy or intolerance to the implants
- Dependency on investigator
- Lack of familiarity with the German language
- Placement in an institution by governmental or juridical advice
- Absent legal capacity
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Effectiveness of hybrid systems ("topping off") compared to rigid spondylodesis in fusion surgery of the lumbar spine: A prospective, randomized, bicentric pilot study ("CD HORIZON BalanC™)
Read the detailed description
Posterior spondylodesis and monosegmental intervertebral cage plus flexible spondylodesis of the superiorly adjacent segment (CD HORIZON BalanC™ Manufacturer: Medtronic)
Control:
Posterior spondylodesis and monosegmental intervertebral cage
- Conditions
- Spine Surgery
- Being tested
- Solera™ Medtronic, CD HORIZON BalanC™ Medtronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solera™ MedtronicDevice
The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Solera™ Medtronic
CD HORIZON BalanC™ MedtronicDevice
The intervention group will receive a hybrid system with a PLIF and a flexible pedicle screw system above the fusion. Surgery will be performed with the following devices:
CD HORIZON BalanC™ Medtronic
| Study group | Role | What they receive |
|---|---|---|
| PLIF | Other | The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Receives: Device: Solera™ Medtronic |
| Hybrid system (PLIF + flexible pedicle screw system above the | Other | The intervention group will receive a hybrid system with a PLIF and a flexible pedicle screw system above the fusion. Receives: Device: CD HORIZON BalanC™ Medtronic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the subscores of physical pain and physical function in the ODI Questionaire
Measured: Baseline to 6 month
Secondary outcomes (1)
MCS and individual dimensions and subscales of the SF-36™
Measured: 60 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Dr. Jan Siewe, University of Cologne
- Investigators
- Jan Siewe, Dr.med., Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551302
- Sponsor's protocol ID
- Ortho-6-2015
- Acronym
- BalanC
- Status last verified
- Sep 2015
- First submitted
- 15 Sep 2015
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Efficacy of Hybrid Systems ("Topping Off") Versus Rigid Spinal Fusion in Lumbar Fusion Surgery: A Dual-center, Prospective, Randomized Pilot Study ("CD Horizon BalanC")"
- ClinicalTrials.gov ID
- NCT02551302
- Acronym / sponsor ID
- BalanC / Ortho-6-2015
- Conditions
- Spine Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Sep 2015 (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.
Effectiveness of hybrid systems ("topping off") compared to rigid spondylodesis in fusion surgery of the lumbar spine: A prospective, randomized, bicentric pilot study ("CD HORIZON BalanC™)
Detailed description
Posterior spondylodesis and monosegmental intervertebral cage plus flexible spondylodesis of the superiorly adjacent segment (CD HORIZON BalanC™ Manufacturer: Medtronic)
Control:
Posterior spondylodesis and monosegmental intervertebral cage
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLIF | Other | Device: Solera™ MedtronicThe control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). |
| Hybrid system (PLIF + flexible pedicle screw system above the | Other | Device: CD HORIZON BalanC™ MedtronicThe intervention group will receive a hybrid system with a PLIF and a flexible pedicle screw system above the fusion. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent
- Legal capacity
- Age ≥ 30 years
- Indication for monosegmental lumbar spine fusion (PLIF or "topping-off ") L2-S1 with osteochondrosis Modic grades I-III [20][21][22] or spondylolisthesis Meyerding grades I-III.
- Radiologic signs of degeneration in the adjacent segment of the intended fusion without signs of instability
Key exclusion criteria (31 listed)
- Motor deficit
- Cauda equina syndrome
- Previous surgical intervention of the lumbar spine
- Relevant peripheral neuropathy
- Acute denervation subsequent to a radiculopathy
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 |
|---|---|---|
| Solera™ MedtronicThe control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Solera™ Medtronic | Device | PLIF |
| CD HORIZON BalanC™ MedtronicThe intervention group will receive a hybrid system with a PLIF and a flexible pedicle screw system above the fusion. Surgery will be performed with the following devices: CD HORIZON BalanC™ Medtronic | Device | Hybrid system (PLIF + flexible pedicle screw system above the |
Primary outcome
Changes in the subscores of physical pain and physical function in the ODI Questionaire
Time frame: Baseline to 6 month
1 secondary outcome
MCS and individual dimensions and subscales of the SF-36™
Time frame: 60 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
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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.
Jan Siewe, Dr.med. principal investigator
University Hospital of Cologne
Questions about this trial
What is this clinical trial studying?
A study testing Solera™ Medtronic and CD HORIZON BalanC™ Medtronic in people with Spine Surgery, run by University of Cologne.
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 5 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 16 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Siewe, Dr.med. (+49(0)221-478-87294, jan.siewe@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the subscores of physical pain and physical function in the ODI Questionaire (time frame: Baseline to 6 month). 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 16 Sep 2015.