Degeneration of Lumbar Intervertebral DiscDYNORFUSENCT01365754
Dynamic Stabilization Versus Fusion
A study testing standard and new in people with Degeneration of Lumbar Intervertebral Disc, run by Technical University of Munich at 1 site in Germany.
Trial summary
The purpose of this study is to compare posterior dynamic stabilization with fusion in the treatment of lumbar degenerative disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degeneration of Lumbar Intervertebral Disc
- What is being tested?
- standard and new
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Mono- or bisegmental symptomatic lumbar degenerative disease with or without stenosis
- Indication for fusion with (i) spondylolisthesis of at least 5mm or segmental vertebral motion of at least 3mm or 10º on flexion/extension radiographs, (ii) predominant low back pain in combination with Modic changes
- Failure of adequate conservative measures for more than 3 months
- Correctly signed informed consent form
Who cannot join
- Olisthesis more than grade I, spondylolisthesis vera, spondylolysis without olisthesis or spinal deformity (i.e. scoliosis of more than 20°, sagittal imbalance)
- Significant comorbidity impeding with surgical success (e.g. osteoporosis, rheumatoid arthritis, mental illness)
- Previous fusion or stabilization surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Posterior Dynamic Stabilization Versus Fusion in the Treatment of Lumbar Degenerative Disease
The purpose of this study is to compare posterior dynamic stabilization with fusion in the treatment of lumbar degenerative disease.
Read the detailed description
Two strategies for treatment of degenerative lumbar instability are in frequent clinical use: fusion versus dynamic stabilization. Up to now it is not clear whether fusion (Gold-standard) or the non-fusion technique is superior. Nevertheless some data are available that dynamic stabilization as a less invasive technique can achieve similar or better results concerning patient satisfaction and re-OP rate compared with fusion as the standard therapy.
- Being tested
- standard, new
- Keywords
- Lumbar degenerative disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardProcedure or surgery
fusion
newProcedure or surgery
dynamic stabilization
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | A - Fusion Receives: Procedure: standard |
| B | Active comparator | B - Dynamic (new) Receives: Procedure: new |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention
Measured: 2 years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degeneration of Lumbar Intervertebral DiscStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365754
- Sponsor's protocol ID
- DYN-1009-MEY-0000-I
- Acronym
- DYNORFUSE
- Status last verified
- Sep 2018
- First submitted
- 1 Jun 2011
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Dynamic Stabilization Versus Fusion in the Treatment of Lumbar Degenerative Disease
- ClinicalTrials.gov ID
- NCT01365754
- Acronym / sponsor ID
- DYNORFUSE / DYN-1009-MEY-0000-I
- Keywords
- Lumbar degenerative disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 3 Jun 2011 (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.
The purpose of this study is to compare posterior dynamic stabilization with fusion in the treatment of lumbar degenerative disease.
Detailed description
Two strategies for treatment of degenerative lumbar instability are in frequent clinical use: fusion versus dynamic stabilization. Up to now it is not clear whether fusion (Gold-standard) or the non-fusion technique is superior. Nevertheless some data are available that dynamic stabilization as a less invasive technique can achieve similar or better results concerning patient satisfaction and re-OP rate compared with fusion as the standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: standardA - Fusion |
| B | Active comparator | Procedure: newB - Dynamic (new) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- Mono- or bisegmental symptomatic lumbar degenerative disease with or without stenosis
- Indication for fusion with (i) spondylolisthesis of at least 5mm or segmental vertebral motion of at least 3mm or 10º on flexion/extension radiographs, (ii) predominant low back pain in combination with Modic changes
- Failure of adequate conservative measures for more than 3 months
- Correctly signed informed consent form
Key exclusion criteria (3 listed)
- Olisthesis more than grade I, spondylolisthesis vera, spondylolysis without olisthesis or spinal deformity (i.e. scoliosis of more than 20°, sagittal imbalance)
- Significant comorbidity impeding with surgical success (e.g. osteoporosis, rheumatoid arthritis, mental illness)
- Previous fusion or stabilization surgery
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 |
|---|---|---|
| standardfusion | Procedure or surgery | A |
| newdynamic stabilization | Procedure or surgery | B |
Primary outcome
Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention
Time frame: 2 years after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard and new in people with Degeneration of Lumbar Intervertebral Disc, run by Technical University of Munich 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 12 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention (time frame: 2 years after intervention). 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 12 Sep 2018; AzTrials last refreshed its copy on 29 Oct 2026.