Intervertebral Disc DisplacementNCT02936739
Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Prosthesis Rotaio (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse
A study testing Anterior cervical discectomy with prosthetic disc replacement / ESP. and Anterior cervical discectomy with prosthetic disc replacement / Rotaio. in people with Intervertebral Disc Displacement, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc prosthetic devices with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Intervertebral Disc Displacement
- What is being tested?
- Anterior cervical discectomy with prosthetic disc replacement / ESP. and Anterior cervical discectomy with prosthetic disc replacement / Rotaio.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Jun 2019
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Indication for monosegmental anterior cervical discectomy with implantation of a disc prosthesis
Who cannot join
- Radiologic signs of extensive bone degeneration in the affected segment
- Necessity of implantation of a device smaller in height than 5 mm (as predicted with teh use of the Vertaplan (TM) software
- Transversal spine cord lesion
- Cervical myelopathy
- Preceding surgery on the cervical spine
- Traumatic lesions of the cervical spine
Show all 24Show fewer
- Radiographic instability in the affected segment: flexion / extension: shift sagittal plane> 3.5 mm or 20% and rotation in the sagittal plane > 20 °, OR in static X-ray examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width and relative sagittal plane angulation > 11º
- signs of instability (Olisthesis) in another segment of the cervical spine
- Active systemic infection
- diseases of the rheumatic type and all autoimmune diseases
- bone metabolic diseases (for example, Paget's disease)
- skeletal metastases
- infections in the cervical spine
- Neurological seizure disorders or other serious neurological disease with risk of falls
- Severe heart failure (NYHA III-IV)
- Bleeding disorders or clopidogrel / coumarins - treatment
- Systemic use of corticosteroids for more than a month in the last 12 months
- Pregnancy
- Legally incompetent patient
- Lactation
- Deformity, anomalies, not fully developed skeleton
- Local tumor disease
- Pre-existing neurologic abnormalities or other shortcomings, such as a Parkinson's disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy
- Drug / drug or alcohol dependence
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Uniklinikum Dresden
Dresden, 01307
Bernhard Rieger, Dr., bernhard.rieger@uniklinikum-dresden.de
About this study
This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc prosthetic devices with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.
- Conditions
- Intervertebral Disc Displacement
- Being tested
- Anterior cervical discectomy with prosthetic disc replacement / ESP., Anterior cervical discectomy with prosthetic disc replacement / Rotaio.
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior cervical discectomy with prosthetic disc replacement / ESP.Device
Anterior cervical discectomy, with the use of the ESP prosthesis (Manufacturer: FH orthopedics, Mulhouse, France) for the disc replacement.
Anterior cervical discectomy with prosthetic disc replacement / Rotaio.Device
Anterior cervical discectomy, with the use of the Rotaio prosthesis (Manufacturer: Signus Med, Alzenau, Germany) for the disc replacement.
| Study group | Role | What they receive |
|---|---|---|
| Elastic spine pad | Experimental | Patients, who receive Elastic Spine Pad (TM) as cervical disc prosthesis after ventral discectomy. Receives: Device: Anterior cervical discectomy with prosthetic disc replacement / ESP. |
| Rotaio | Active comparator | Patients, who receive Rotaio (TM) as cervical disc prosthesis after ventral discectomy. Receives: Device: Anterior cervical discectomy with prosthetic disc replacement / Rotaio. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck disability index compared to baseline
Measured: 6 weeks, 3, 6, 12 and 24 months postoperative
Secondary outcomes (21)
Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline
Measured: 6 weeks, 3, 6, 12 and 24 months postoperative
Change in EuroQOL (EQ-5D) compared to baseline
Measured: 6 weeks, 3, 6, 12 and 24 months postoperative
Change in Core Outcome Measure Index (COMI) compared to baseline
Measured: 6 weeks, 3, 6, 12 and 24 months postoperative
Change in flexion and extension radiographs compared to baseline
Measured: 6 weeks, 3, 6 and 12 months postoperative
Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline
Measured: 6 weeks, 3, 6 and 12 months postoperative
Change in consumption of analgetics compared to baseline
The change in analgetics consumption will be assessed on a scale of increase - stable - reduction.
Measured: 6 weeks, 3, 6, 12 and 24 months postoperative
Return to work
Measured: 6 weeks postoperative
Return to work
Measured: 3 months postoperative
Return to work
Measured: 6 months postoperative
Return to work
Measured: 12 months postoperative
Return to work
Measured: 24 months postoperative
Mortality
Measured: 6 weeks postoperative
Mortality
Measured: 3 months postoperative
Mortality
Measured: 6 months postoperative
Mortality
Measured: 12 months postoperative
Mortality
Measured: 24 months postoperative
Adverse effects
Measured: 6 weeks postoperative
Adverse effects
Measured: 3 months postoperative
Adverse effects
Measured: 6 months postoperative
Adverse effects
Measured: 12 months postoperative
Adverse effects
Measured: 24 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DisplacementStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936739
- Sponsor's protocol ID
- NCH_ESPvsRotaio
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Prosthesis Rotaio (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse
- ClinicalTrials.gov ID
- NCT02936739
- Acronym / sponsor ID
- NCH_ESPvsRotaio
- Conditions
- Intervertebral Disc Displacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 18 Oct 2016 (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.
This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc prosthetic devices with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastic spine pad | Experimental | Device: Anterior cervical discectomy with prosthetic disc replacement / ESP.Patients, who receive Elastic Spine Pad (TM) as cervical disc prosthesis after ventral discectomy. |
| Rotaio | Active comparator | Device: Anterior cervical discectomy with prosthetic disc replacement / Rotaio.Patients, who receive Rotaio (TM) as cervical disc prosthesis after ventral discectomy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Indication for monosegmental anterior cervical discectomy with implantation of a disc prosthesis
Key exclusion criteria (24 listed)
- Radiologic signs of extensive bone degeneration in the affected segment
- Necessity of implantation of a device smaller in height than 5 mm (as predicted with teh use of the Vertaplan (TM) software
- Transversal spine cord lesion
- Cervical myelopathy
- Preceding surgery on the cervical 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 |
|---|---|---|
| Anterior cervical discectomy with prosthetic disc replacement / ESP.Anterior cervical discectomy, with the use of the ESP prosthesis (Manufacturer: FH orthopedics, Mulhouse, France) for the disc replacement. | Device | Elastic spine pad |
| Anterior cervical discectomy with prosthetic disc replacement / Rotaio.Anterior cervical discectomy, with the use of the Rotaio prosthesis (Manufacturer: Signus Med, Alzenau, Germany) for the disc replacement. | Device | Rotaio |
Primary outcome
Change in Neck disability index compared to baseline
Time frame: 6 weeks, 3, 6, 12 and 24 months postoperative
21 secondary outcomes
Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline
Time frame: 6 weeks, 3, 6, 12 and 24 months postoperative
Change in EuroQOL (EQ-5D) compared to baseline
Time frame: 6 weeks, 3, 6, 12 and 24 months postoperative
Change in Core Outcome Measure Index (COMI) compared to baseline
Time frame: 6 weeks, 3, 6, 12 and 24 months postoperative
Change in flexion and extension radiographs compared to baseline
Time frame: 6 weeks, 3, 6 and 12 months postoperative
Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline
Time frame: 6 weeks, 3, 6 and 12 months postoperative
Change in consumption of analgetics compared to baseline
Time frame: 6 weeks, 3, 6, 12 and 24 months postoperative
Return to work
Time frame: 6 weeks postoperative
Return to work
Time frame: 3 months postoperative
Return to work
Time frame: 6 months postoperative
Return to work
Time frame: 12 months postoperative
Return to work
Time frame: 24 months postoperative
Mortality
Time frame: 6 weeks postoperative
Mortality
Time frame: 3 months postoperative
Mortality
Time frame: 6 months postoperative
Mortality
Time frame: 12 months postoperative
Mortality
Time frame: 24 months postoperative
Adverse effects
Time frame: 6 weeks postoperative
Adverse effects
Time frame: 3 months postoperative
Adverse effects
Time frame: 6 months postoperative
Adverse effects
Time frame: 12 months postoperative
Adverse effects
Time frame: 24 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior cervical discectomy with prosthetic disc replacement / ESP. and Anterior cervical discectomy with prosthetic disc replacement / Rotaio. in people with Intervertebral Disc Displacement, run by Technische Universität Dresden 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 1 inclusion and 24 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 18 Oct 2016. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neck disability index compared to baseline (time frame: 6 weeks, 3, 6, 12 and 24 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 18 Oct 2016.