Cervical Disc DegenerationPhase 1/2PalcageNCT01607775
In-house Produced PMMA- Versus PEEK-cages
A Phase 1/2 study testing Implantation of a PEEK-cage and PMMA-cage in people with Cervical Disc Degeneration and Cervical Stenosis, run by Universitätsmedizin Mannheim.
Trial summary
Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Disc Degeneration, Cervical Stenosis
- What is being tested?
- Implantation of a PEEK-cage and PMMA-cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Feb 2012
- Phase
- Phase 1/2
- 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
- virgin spines
- no emergency operation
- age above 18
- sufficient knowledge of the German language
- indication for anterior cervical discectomy and fusion
- absence of concomitant spinal disease
Who cannot join
- prior cervical surgery
- indications other than ACDF
- concomitant neoplastic, metabolic, severe general or infectious disease
About this study
Official title: Clinical Characterization of In-house Produced PMMA-cages in Patients With Cervical Pathology
Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. As control, a commercially available PEEK-cage was used, patients were randomized using minimization randomization, controlling for age and bone mineral densitiy. The investigators hypothesize that the newly developed cage has similar clinical and radiological qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.
- Conditions
- Cervical Disc Degeneration, Cervical Stenosis
- Being tested
- Implantation of a PEEK-cage, PMMA-cage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a PEEK-cageDevice
A commercially avaliable cuboid cervical cage will be implantet
PMMA-cageDevice
The in-house produced cervical cage will be implanted
| Study group | Role | What they receive |
|---|---|---|
| PEEK-cage | Active comparator | Patients will receive a PEEK-cage Receives: Device: Implantation of a PEEK-cage |
| PMMA-cage | Experimental | Not described Receives: Device: PMMA-cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome (NDI)
NDI (Neck disability index) will be measured prior to surgery and 12 months after surgery. A difference of 20% between both groups is considered to be clinically significant, which is proposed for the experimental implant (PMMA-cage).
Measured: 12 months postoperative
Secondary outcomes (1)
Clinical outcome (VAS-neck), Subsidence
- VAS-neck will be measured prior to surgery and 12 months after surgery. A difference of 20% between both groups is considered to be clinically significant, which is proposed for the experimental implant (PMMA-cage).
- Cage Subsidence will be measured using lateral radiographs prior to surgery and 12 months after surgery. Due to an improved cage design, significantly less subsidence is proposed for the experimental implant (PMMA-cage).
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startFeb 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc DegenerationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Barth, MD, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607775
- Sponsor's protocol ID
- 2007-256M-MA
- Acronym
- Palcage
- Status last verified
- Jun 2012
- First submitted
- 22 May 2012
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characterization of In-house Produced PMMA-cages in Patients With Cervical Pathology
- ClinicalTrials.gov ID
- NCT01607775
- Acronym / sponsor ID
- Palcage / 2007-256M-MA
- Conditions
- Cervical Disc Degeneration, Cervical Stenosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 May 2012 (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.
Subsidence of cervical cages is a common problem. For the study, a new polyacrylmethacrylate cage was designed and prospectively implanted in patients with a mono- or bilevel cervical pathology. As control, a commercially available PEEK-cage was used, patients were randomized using minimization randomization, controlling for age and bone mineral densitiy. The investigators hypothesize that the newly developed cage has similar clinical and radiological qualities compared to the PEEK-cage, but at a much more favourable cost-performance ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK-cage | Active comparator | Device: Implantation of a PEEK-cagePatients will receive a PEEK-cage |
| PMMA-cage | Experimental | Device: PMMA-cage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- virgin spines
- no emergency operation
- age above 18
- sufficient knowledge of the German language
- indication for anterior cervical discectomy and fusion
Key exclusion criteria (3 listed)
- prior cervical surgery
- indications other than ACDF
- concomitant neoplastic, metabolic, severe general or infectious disease
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 |
|---|---|---|
| Implantation of a PEEK-cageA commercially avaliable cuboid cervical cage will be implantet | Device | PEEK-cage |
| PMMA-cageThe in-house produced cervical cage will be implanted | Device | PMMA-cage |
Primary outcome
Clinical outcome (NDI)
Time frame: 12 months postoperative
NDI (Neck disability index) will be measured prior to surgery and 12 months after surgery. A difference of 20% between both groups is considered to be clinically significant, which is proposed for the experimental implant (PMMA-cage).
1 secondary outcome
Clinical outcome (VAS-neck), Subsidence
Time frame: 12 months postoperative
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 5 Jun 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Implantation of a PEEK-cage and PMMA-cage in people with Cervical Disc Degeneration and Cervical Stenosis, run by Universitätsmedizin Mannheim.
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 6 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 5 Jun 2012. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (NDI) (time frame: 12 months postoperative). 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 5 Jun 2012.