Vertebral FusionNCT03063008
Transforaminal Lumbar Interbody Fusion in PEEK Oblique Cages With and Without Titanium Coating
A study testing PEEK and TiPEEK in people with Vertebral Fusion, run by Mohammad ARAB MOTLAGH.
Trial summary
Clinical outcome with regard to oswestry disability index and lumbar fusion rate after implantation of titanium coated PEEK cage and common PEEK cage Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Fusion
- What is being tested?
- PEEK and TiPEEK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 16 Jan 2012to 1 Dec 2013
- 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
- Persistence of
- low back pain,
- sciatica and
- spinal claudication after conservative treatment attributed to L3 to L5 lumbar segments.
Who cannot join
- previous lumbar spinal surgery
- body mass index >35 kg/m²
About this study
Official title: "Randomized Evaluation of Bone Ingrowth After Intervertebral Body Fusion With Either MectaLIF® PEEK or MectaLIF® TiPEEK Oblique"
Clinical outcome with regard to oswestry disability index and lumbar fusion rate after implantation of titanium coated PEEK cage and common PEEK cage
Read the detailed description
Cages made of polyetheretherketone (PEEK) and titanium materials reliably produce successful fusion rates and good clinical outcomes. However, there is a paucity of studies that have assessed the optimal material of cage systems. The primary objective of this study was to compare the Oswestry Disability Index (ODI) after instrumented transforaminal lumbar interbody fusion (TLIF) using either titanium-coated polyetheretherketone (TiPEEK) or common PEEK cages. Secondary objectives were to assess differences in fusion rates and differences in pain and in quality of life between these groups.
- Conditions
- Vertebral Fusion
- Being tested
- PEEK, TiPEEK
- Keywords
- Lumbar spine; Fusion; Titanium; PEEK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEKDevice
Procedure/Surgery:
TLIF fusion with common PEEK cages.
TiPEEKDevice
Procedure/Surgery:
TLIF fusion with titanium coated PEEK cages.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar fusion with PEEK cage | Other | Control arm Receives: Device: PEEK |
| Lumbar fusion with TiPEEK cage | Other | Study arm Receives: Device: TiPEEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome assessed by Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK
Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK
Measured: 12 months
Secondary outcomes (1)
Fusion result
Fusion rate after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start16 Jan 2012
- Primary completion1 Sep 2013
- Study completion1 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral FusionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammad ARAB MOTLAGH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad ARAB MOTLAGH, Johann Wolfgang Goethe University Hospital
- Investigators
- Mohammad Arabmotlagh, MD, PhD, Study director, Department of Orthopedic Surgery, University Hospital Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063008
- Sponsor's protocol ID
- TiPEEK Cage
- Status last verified
- Feb 2017
- First submitted
- 16 Feb 2017
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Randomized Evaluation of Bone Ingrowth After Intervertebral Body Fusion With Either MectaLIF® PEEK or MectaLIF® TiPEEK Oblique"
- ClinicalTrials.gov ID
- NCT03063008
- Acronym / sponsor ID
- TiPEEK Cage
- Conditions
- Vertebral Fusion
- Keywords
- Lumbar spine; Fusion; Titanium; PEEK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mohammad ARAB MOTLAGHUniversity, hospital or other
- Study start
- 16 Jan 2012 (actual)
- Primary completion
- 1 Sep 2013 (actual)
- Study completion
- 1 Dec 2013 (actual)
- First posted
- 24 Feb 2017 (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.
Clinical outcome with regard to oswestry disability index and lumbar fusion rate after implantation of titanium coated PEEK cage and common PEEK cage
Detailed description
Cages made of polyetheretherketone (PEEK) and titanium materials reliably produce successful fusion rates and good clinical outcomes. However, there is a paucity of studies that have assessed the optimal material of cage systems. The primary objective of this study was to compare the Oswestry Disability Index (ODI) after instrumented transforaminal lumbar interbody fusion (TLIF) using either titanium-coated polyetheretherketone (TiPEEK) or common PEEK cages. Secondary objectives were to assess differences in fusion rates and differences in pain and in quality of life between these groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar fusion with PEEK cage | Other | Device: PEEKControl arm |
| Lumbar fusion with TiPEEK cage | Other | Device: TiPEEKStudy arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persistence of
- low back pain,
- sciatica and
- spinal claudication after conservative treatment attributed to L3 to L5 lumbar segments.
Key exclusion criteria (2 listed)
- previous lumbar spinal surgery
- body mass index >35 kg/m²
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 |
|---|---|---|
| PEEKProcedure/Surgery: TLIF fusion with common PEEK cages. | Device | Lumbar fusion with PEEK cage |
| TiPEEKProcedure/Surgery: TLIF fusion with titanium coated PEEK cages. | Device | Lumbar fusion with TiPEEK cage |
Primary outcome
Clinical outcome assessed by Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK
Time frame: 12 months
Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK
1 secondary outcome
Fusion result
Time frame: 12 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 24 Feb 2017.
- 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.
Mohammad Arabmotlagh, MD, PhD study director
Department of Orthopedic Surgery, University Hospital Frankfurt
Questions about this trial
What is this clinical trial studying?
A study testing PEEK and TiPEEK in people with Vertebral Fusion, run by Mohammad ARAB MOTLAGH.
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 4 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: finished, as of the sponsor's last update on 24 Feb 2017. 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?
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?
Clinical outcome assessed by Oswestry Disability Index (ODI) after instrumented transforaminal lumbar fusion with TiPEEK or common PEEK (time frame: 12 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 24 Feb 2017.