Multilevel Cervical Spinal StenosisMISDCSNCT01988259
Head-neck Coordination Analysis After Minimally Invasive Surgery in the Dorsal Cervical Spine
A study testing Bilateral approach for Laminoplasty, Unilateral approach for laminoplasty and Subperiosteal approach for foraminotomy in people with Multilevel Cervical Spinal Stenosis and Single Brachial Radiculopathy, run by Schoen Klinik Hamburg Eilbek at 1 site in Germany.
Trial summary
To proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an apparatus to examine head-neck-coordination was constructed. Two different surgical techniques will be compared: Laminoplasty: open approach vs minimally invasive surgery (MIS)-approach; Foraminotomy: open approach vs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multilevel Cervical Spinal Stenosis, Single Brachial Radiculopathy
- What is being tested?
- Bilateral approach for Laminoplasty, Unilateral approach for laminoplasty and Subperiosteal approach for foraminotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Dec 2015
- 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
- radicular or myelopathic compression syndrome in the cervical spine
Who cannot join
- neurological diseases with influence on the neuromuscular function
- previous surgery on the cervical spine
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Schoen Klinik Hamburg Eilbek
Hamburg, Free and Hanseatic City of Hamburg, 22081
Ralph Kothe, MD, 0049 40 2092 ext. 7001, rkothe@Schoen-Kliniken.de
Alexander Gude, MD, 0049 40 2092 ext. 7068, agude@Schoen-Kliniken.de
About this study
Official title: Comparison of Open vs Minimally Invasive Dorsal Approaches for Foraminotomy and Laminoplasty in the Cervical Spine Through Performance of Head-neck-coordination Analysis
To proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an apparatus to examine head-neck-coordination was constructed.
Two different surgical techniques will be compared:
Laminoplasty: open approach vs minimally invasive surgery (MIS)-approach; Foraminotomy: open approach vs MIS-approach. Each patient will be tested before surgery, postoperative as well as 3 and 12 month follow-up.
Hypothesis is that patients after MIS-approaches perform better in their head-neck-coordination as patients with open approaches.
- Being tested
- Bilateral approach for Laminoplasty, Unilateral approach for laminoplasty, Subperiosteal approach for foraminotomy, Transmuscular approach for foraminotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral approach for LaminoplastyProcedure or surgery
Open bilateral approach for laminoplasty in multilevel cervical spinal stenosis
Unilateral approach for laminoplastyProcedure or surgery
Unilateral minimally invasive approach for laminoplasty in multilevel cervical spinal stenosis.
Subperiosteal approach for foraminotomyProcedure or surgery
Unilateral subperiostal approach for single level foraminotomy
Transmuscular approach for foraminotomyProcedure or surgery
Unilateral transmuscular approach for single level foraminotomy
| Study group | Role | What they receive |
|---|---|---|
| Bilateral approach for laminoplasty | Active comparator | Open approach for laminoplasty Receives: Procedure: Bilateral approach for Laminoplasty |
| Unilateral approach for laminoplasty | Active comparator | Minimally invasive approach for laminoplasty Receives: Procedure: Unilateral approach for laminoplasty |
| Subperiosteal approach for foraminotomy | Active comparator | Open approach for foraminotomy Receives: Procedure: Subperiosteal approach for foraminotomy |
| Transmuscular approach for foraminotomy | Active comparator | Minimally invasive approach for foraminotomy Receives: Procedure: Transmuscular approach for foraminotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of head-neck-coordination after surgery of the dorsal cervical spine
The primary outcomes of this study are the motor control performance measures assessed using force and position controlled tasks. In addition to motor control performance, secondary outcome measures of patient-oriented outcome measures (e.g. pain, disability, etc.) will be collected.
Performance measures will consist of the following tasks:
- Head-Neck Position Tracking - Rotation and Flexion/Extension
- Head-Neck Force Tracking - Flexion, Extension and Lateral Bending Left/Right
During the tracking task, a time-varying target (input signal) will be displayed. The participant will be asked to track the specified target by controlling his/her head-neck angle (position tracking) or moment (force tracking). The head position or force during these trials will represent the output signal for the motor control system. These signals will be collected and analyzed in the time and frequency domain to assess error in head-neck motor control.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multilevel Cervical Spinal StenosisStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schoen Klinik Hamburg Eilbek
- Sponsor type
- University, hospital or other
- Collaborators
- Jacek Cholewicki PhD, MSU Center for Orthopedic Research
- Responsible party
- Principal investigator, Ralph Kothe, PD Dr. med., Schoen Klinik Hamburg Eilbek
- Investigators
- Ralph Kothe, MD, Principal investigator, Spine Unit @ Schoen Klinik Hamburg Eilbek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988259
- Sponsor's protocol ID
- MISDCS
- Acronym
- MISDCS
- Status last verified
- May 2015
- First submitted
- 13 Nov 2013
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Open vs Minimally Invasive Dorsal Approaches for Foraminotomy and Laminoplasty in the Cervical Spine Through Performance of Head-neck-coordination Analysis
- ClinicalTrials.gov ID
- NCT01988259
- Acronym / sponsor ID
- MISDCS / MISDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Schoen Klinik Hamburg EilbekUniversity, hospital or other
- Collaborators
- Jacek Cholewicki PhD, MSU Center for Orthopedic Research
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 20 Nov 2013 (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.
To proof patients' benefit of minimally invasive surgery in the dorsal cervical spine an apparatus to examine head-neck-coordination was constructed.
Two different surgical techniques will be compared:
Laminoplasty: open approach vs minimally invasive surgery (MIS)-approach; Foraminotomy: open approach vs MIS-approach. Each patient will be tested before surgery, postoperative as well as 3 and 12 month follow-up.
Hypothesis is that patients after MIS-approaches perform better in their head-neck-coordination as patients with open approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bilateral approach for laminoplasty | Active comparator | Procedure: Bilateral approach for LaminoplastyOpen approach for laminoplasty |
| Unilateral approach for laminoplasty | Active comparator | Procedure: Unilateral approach for laminoplastyMinimally invasive approach for laminoplasty |
| Subperiosteal approach for foraminotomy | Active comparator | Procedure: Subperiosteal approach for foraminotomyOpen approach for foraminotomy |
| Transmuscular approach for foraminotomy | Active comparator | Procedure: Transmuscular approach for foraminotomyMinimally invasive approach for foraminotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- radicular or myelopathic compression syndrome in the cervical spine
Key exclusion criteria (2 listed)
- neurological diseases with influence on the neuromuscular function
- previous 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 |
|---|---|---|
| Bilateral approach for LaminoplastyOpen bilateral approach for laminoplasty in multilevel cervical spinal stenosis | Procedure or surgery | Bilateral approach for laminoplasty |
| Unilateral approach for laminoplastyUnilateral minimally invasive approach for laminoplasty in multilevel cervical spinal stenosis. | Procedure or surgery | Unilateral approach for laminoplasty |
| Subperiosteal approach for foraminotomyUnilateral subperiostal approach for single level foraminotomy | Procedure or surgery | Subperiosteal approach for foraminotomy |
| Transmuscular approach for foraminotomyUnilateral transmuscular approach for single level foraminotomy | Procedure or surgery | Transmuscular approach for foraminotomy |
Primary outcome
Performance of head-neck-coordination after surgery of the dorsal cervical spine
Time frame: one year
The primary outcomes of this study are the motor control performance measures assessed using force and position controlled tasks. In addition to motor control performance, secondary outcome measures of patient-oriented outcome measures (e.g. pain, disability, etc.) will be collected. Performance measures will consist of the following tasks: * Head-Neck Position Tracking - Rotation and Flexion/Extension * Head-Neck Force Tracking - Flexion, Extension and Lateral Bending Left/Right During the tracking task, a time-varying target (input signal) will be displayed. The participant will be asked to track the specified target by controlling his/her head-neck angle (position tracking) or moment (force tracking). The head position or force during these trials will represent the output signal for the motor control system. These signals will be collected and analyzed in the time and frequency domain to assess error in head-neck motor control.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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.
Ralph Kothe, MD principal investigator
Spine Unit @ Schoen Klinik Hamburg Eilbek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral approach for Laminoplasty, Unilateral approach for laminoplasty and Subperiosteal approach for foraminotomy in people with Multilevel Cervical Spinal Stenosis and Single Brachial Radiculopathy, run by Schoen Klinik Hamburg Eilbek 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 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: status not confirmed, as of the sponsor's last update on 22 May 2015. 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?
Contact Ralph Kothe, MD (0049 40 2092 ext. 7001, rkothe@Schoen-Kliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of head-neck-coordination after surgery of the dorsal cervical spine (time frame: one year). 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 22 May 2015.