Spine SurgeryNCT03404232
Radiological and Clinical Efficacy of a Hybrid Spinal Implant ("Topping Off"): a Mono-center, Prospective Clinical Trial
A study testing Dynesys DTO device (Zimmer Spine, Inc.) in people with Spine Surgery, run by University Hospital, Aachen at 1 site in Germany.
Trial summary
The study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical outcome and radiological alteration in a single-center prospective setting. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Spine Surgery
- What is being tested?
- Dynesys DTO device (Zimmer Spine, Inc.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2012to 31 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Legal capacity
- Age ≥ 18 years
- Indication for monosegmental lumbar spine fusion (PLIF or "topping-off ") L2-S1 with osteochondrosis Modic grades I-III 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 or >Pfirrmann grade IV
- 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
1 site in 1 country.
About this study
Official title: The Use of the DTO Hybrid Dynamic Device: a Clinical Outcome- and Radiological-based Prospective Clinical Trial
The study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical outcome and radiological alteration in a single-center prospective setting.
Read the detailed description
Posterior spondylodesis and monosegmental intervertebral cage plus flexible instrumentation of the superiorly adjacent segment (Dynesys DTO).
Planned follow-up visits up to 48 months with documentation of health-related outcome measurement instruments and radiological control of possible segment alteration and device-related complication.
- Conditions
- Spine Surgery
- Being tested
- Dynesys DTO device (Zimmer Spine, Inc.)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynesys DTO device (Zimmer Spine, Inc.)Device
All patients receive posterior hybrid instrumentation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | patients with their first surgical intervention at the lumbar spine receive the Dynesys DTO device (Zimmer Spine, Inc.). Receives: Device: Dynesys DTO device (Zimmer Spine, Inc.) |
| Group 2 | Active comparator | patients with a previous surgical decompression but non-fusion procedure after lumbar spinal stenosis surgery receive the Dynesys DTO device (Zimmer Spine, Inc.). Receives: Device: Dynesys DTO device (Zimmer Spine, Inc.) |
| Group 3 | Active comparator | patients with the medical history of PLIF-/TLIF-technique and later onset of symptomatic ASD within the superior adjacent segment receive the Dynesys DTO device (Zimmer Spine, Inc.). Receives: Device: Dynesys DTO device (Zimmer Spine, Inc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the health-related outcome measurement instruments (ODI)
Measured: 24-48 months
Changes in the health-related outcome measurement instruments (COMI)
Measured: 24-48 months
Changes in the health-related outcome measurement instruments (SF-36)
Measured: 24-48 months
Radiological outcomes
Radiological changes within the adjacent segment
Measured: 24-48 months
Secondary outcomes (2)
Device complication (breakage, loosening, etc.)
Complication regarding the device
Measured: 24 - 48 months
Patient-related complication
general and surgical complication
Measured: 24- 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Jan 2012
- Primary completion31 Dec 2016
- Study completion31 Dec 2017
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 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All patients requiring lumbar spinal surgery by the use of a hybrid spinal implant (DTO): (1) patients with their first surgical intervention at the lumbar spine, (2) patients with a previous surgical decompression but non-fusion procedure after LSS and (3) patients with medical history of PLIF-/TLIF-technique and later onset of symptomatic ASD within the superior adjacent segment.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Aachen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Herren, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404232
- Sponsor's protocol ID
- UKKuUKA001
- Status last verified
- Jan 2018
- First submitted
- 5 Jan 2018
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herren C, Sobottke R, Pishnamaz M, Scheyerer MJ, Bredow J, Westermann L, Berger EM, Oikonomidis S, Eysel P, Siewe J. The use of the DTO hybrid dynamic device: a clinical outcome- and radiological-based prospective clinical trial. BMC Musculoskelet Disord. 2018 Jun 21;19(1):199. doi: 10.1186/s12891-018-2103-x.
PubMed 30016956
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the DTO Hybrid Dynamic Device: a Clinical Outcome- and Radiological-based Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT03404232
- Acronym / sponsor ID
- UKKuUKA001
- Conditions
- Spine Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, AachenUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 19 Jan 2018 (actual)
- 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 study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical outcome and radiological alteration in a single-center prospective setting.
Detailed description
Posterior spondylodesis and monosegmental intervertebral cage plus flexible instrumentation of the superiorly adjacent segment (Dynesys DTO).
Planned follow-up visits up to 48 months with documentation of health-related outcome measurement instruments and radiological control of possible segment alteration and device-related complication.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All patients requiring lumbar spinal surgery by the use of a hybrid spinal implant (DTO): (1) patients with their first surgical intervention at the lumbar spine, (2) patients with a previous surgical decompression but non-fusion procedure after LSS and (3) patients with medical history of PLIF-/TLIF-technique and later onset of symptomatic ASD within the superior adjacent segment.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: Dynesys DTO device (Zimmer Spine, Inc.)patients with their first surgical intervention at the lumbar spine receive the Dynesys DTO device (Zimmer Spine, Inc.). |
| Group 2 | Active comparator | Device: Dynesys DTO device (Zimmer Spine, Inc.)patients with a previous surgical decompression but non-fusion procedure after lumbar spinal stenosis surgery receive the Dynesys DTO device (Zimmer Spine, Inc.). |
| Group 3 | Active comparator | Device: Dynesys DTO device (Zimmer Spine, Inc.)patients with the medical history of PLIF-/TLIF-technique and later onset of symptomatic ASD within the superior adjacent segment receive the Dynesys DTO device (Zimmer Spine, Inc.). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent
- Legal capacity
- Age ≥ 18 years
- Indication for monosegmental lumbar spine fusion (PLIF or "topping-off ") L2-S1 with osteochondrosis Modic grades I-III 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 |
|---|---|---|
| Dynesys DTO device (Zimmer Spine, Inc.)All patients receive posterior hybrid instrumentation. | Device | Group 1, Group 2, Group 3 |
Primary outcome
Changes in the health-related outcome measurement instruments (ODI)
Time frame: 24-48 months
Changes in the health-related outcome measurement instruments (COMI)
Time frame: 24-48 months
Changes in the health-related outcome measurement instruments (SF-36)
Time frame: 24-48 months
Radiological outcomes
Time frame: 24-48 months
Radiological changes within the adjacent segment
2 secondary outcomes
Device complication (breakage, loosening, etc.)
Time frame: 24 - 48 months
Patient-related complication
Time frame: 24- 48 months
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 19 Jan 2018.
- Derived from this study: PubMed 30016956Herren C, Sobottke R, Pishnamaz M, Scheyerer MJ, Bredow J, Westermann L, Berger EM, Oikonomidis S, Eysel P, Siewe J. The use of the DTO hybrid dynamic device: a clinical outcome- and radiological-based prospective clinical trial. BMC Musculoskelet Disord. 2018 Jun 21;19(1):199. doi: 10.1186/s12891-018-2103-x.
- 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.
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 Dynesys DTO device (Zimmer Spine, Inc.) in people with Spine Surgery, run by University Hospital, Aachen 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 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: finished, as of the sponsor's last update on 19 Jan 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?
Changes in the health-related outcome measurement instruments (ODI) (time frame: 24-48 months). The study lists 4 primary outcomes in all. 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 NCT03404232, 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 19 Jan 2018.