SpondylolisthesisTopping-offNCT01224379
Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine
A study testing Topping off system and monosegmental PLIF in people with Spondylolisthesis and Erosive Osteochondrosis in L2-S1, run by University of Cologne at 1 site in Germany.
Trial summary
Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome? Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Spondylolisthesis, Erosive Osteochondrosis in L2-S1
- What is being tested?
- Topping off system and monosegmental PLIF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Oct 2012
- 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
- Male or female >30 years of age
- Lumbar spine pathology with indication for monosegmental PLIF
- Radiological signs of a degeneration of the adjacent segment without instability
Who cannot join
- 1. Radiological signs of existing instability of the adjacent segment 2. Normal endplates and no disc desiccation in MRI in the adjacent seg-ment 3. Previous surgery of the lumbar spine
- -
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Cologne, Department of Orthopedics& traumasurgery
Cologne, 50931
Jan Siewe, Dr., +49-221-478-87294, studienzentrum-ortho-unfall@uk-koeln.de
Jan Siewe, Dr.
About this study
Official title: Clinical Trial of the Efficacy of Hybrid Systems(Topping Off)in Comparison to the Conventional Spondylodesis in Fusion-surgery in the Lumbal Spine: a Prospective, Randomised Study
Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome?
Read the detailed description
Primary efficacy endpoint:
The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).
Key secondary endpoint(s):
- Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36
- Individual dimensions of the Oswestry Disability Index (ODI)
- Time until radiological adjacent instability and comparison to the clinical outcome
- Capacity of work at the time of surgery and after surgery, time until return to work
Assessment of safety:
- Treatment complication in control and intervention groups (SAE-management)
- A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias
- Being tested
- Topping off system, monosegmental PLIF
- Keywords
- Lumbar spine, fusion, adjacent instability, topping-off.
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topping off systemDevice
Also called Topping off
The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).
monosegmental PLIFDevice
The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)
| Study group | Role | What they receive |
|---|---|---|
| Arm1: "topping off" system | Other | The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion). Receives: Device: Topping off system |
| Arm 2: monosegmental PLIF | Other | The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis) Receives: Device: monosegmental PLIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF36
Primary efficacy endpoint:
The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).
Measured: 6 Month
Secondary outcomes (5)
1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36
- Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36 follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline
Measured: 6 weeks
Safety
Assessment of safety:
- Treatment complication in control and intervention groups (SAE-management)
- A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias
Measured: all time
Individual dimensions of the Oswestry Disability Index (ODI)
Individual dimensions of the Oswestry Disability Index (ODI) follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline
Measured: 6weeks
Time until radiological adjacent instability and comparison to the clinical outcome
Time until radiological adjacent instability and comparison to the clinical outcome follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline
Measured: 6 weeks
Capacity of work at the time of surgery and after surgery, time until return to work
Capacity of work at the time of surgery and after surgery, time until return to work follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionJul 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpondylolisthesisStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Investigators
- Jan Siewe, Dr., Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224379
- Sponsor's protocol ID
- Uni-Köln-1223
- Other IDs
- Uni-Köln-1223
- Acronym
- Topping-off
- Status last verified
- Sep 2010
- First submitted
- 19 Oct 2010
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Siewe J, Otto C, Knoell P, Koriller M, Stein G, Kaulhausen T, Eysel P, Zarghooni K, Franklin J, Sobottke R. Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2011 Oct 18;12:239. doi: 10.1186/1471-2474-12-239.
PubMed 22008088
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of the Efficacy of Hybrid Systems(Topping Off)in Comparison to the Conventional Spondylodesis in Fusion-surgery in the Lumbal Spine: a Prospective, Randomised Study
- ClinicalTrials.gov ID
- NCT01224379
- Acronym / sponsor ID
- Topping-off / Uni-Köln-1223
- Keywords
- Lumbar spine, fusion, adjacent instability, topping-off.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 20 Oct 2010 (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.
Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome?
Detailed description
Primary efficacy endpoint:
The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).
Key secondary endpoint(s):
- Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36
- Individual dimensions of the Oswestry Disability Index (ODI)
- Time until radiological adjacent instability and comparison to the clinical outcome
- Capacity of work at the time of surgery and after surgery, time until return to work
Assessment of safety:
- Treatment complication in control and intervention groups (SAE-management)
- A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1: "topping off" system | Other | Device: Topping off systemThe intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion). |
| Arm 2: monosegmental PLIF | Other | Device: monosegmental PLIFThe control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female >30 years of age
- Lumbar spine pathology with indication for monosegmental PLIF
- Radiological signs of a degeneration of the adjacent segment without instability
Key exclusion criteria (2 listed)
- 1. Radiological signs of existing instability of the adjacent segment 2. Normal endplates and no disc desiccation in MRI in the adjacent seg-ment 3. Previous surgery of the lumbar spine
- -
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 |
|---|---|---|
| Topping off systemAlso: Topping offThe intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion). | Device | Arm1: "topping off" system |
| monosegmental PLIFThe control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis) | Device | Arm 2: monosegmental PLIF |
Primary outcome
SF36
Time frame: 6 Month
Primary efficacy endpoint: The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).
5 secondary outcomes
1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36
Time frame: 6 weeks
Safety
Time frame: all time
Individual dimensions of the Oswestry Disability Index (ODI)
Time frame: 6weeks
Time until radiological adjacent instability and comparison to the clinical outcome
Time frame: 6 weeks
Capacity of work at the time of surgery and after surgery, time until return to work
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
- Derived from this study: PubMed 22008088Siewe J, Otto C, Knoell P, Koriller M, Stein G, Kaulhausen T, Eysel P, Zarghooni K, Franklin J, Sobottke R. Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2011 Oct 18;12:239. doi: 10.1186/1471-2474-12-239.
- Related InfoLink provided by the sponsor.
Related trials for Spondylolisthesis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
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. principal investigator
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topping off system and monosegmental PLIF in people with Spondylolisthesis and Erosive Osteochondrosis in L2-S1, run by University of Cologne at 1 site in Germany.
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 3 inclusion and 2 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 20 Oct 2010. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Siewe, Dr. (+49-221-478-87294, studienzentrum-ortho-unfall@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF36 (time frame: 6 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01224379, which also lists 1 linked publication.
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 20 Oct 2010.