Multilevel Cervical Spinal Stenosis Clinical Trial
— MISDCSOfficial title:
Comparison of Open vs Minimally Invasive Dorsal Approaches for Foraminotomy and Laminoplasty in the Cervical Spine Through Performance of Head-neck-coordination Analysis
| NCT number | NCT01988259 |
| Other study ID # | MISDCS |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | November 13, 2013 |
| Last updated | May 21, 2015 |
| Start date | September 2013 |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - radicular or myelopathic compression syndrome in the cervical spine Exclusion Criteria: - neurological diseases with influence on the neuromuscular function - previous surgery on the cervical spine |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Schoen Klinik Hamburg Eilbek | Hamburg |
| Lead Sponsor | Collaborator |
|---|---|
| Schoen Klinik Hamburg Eilbek | Jacek Cholewicki PhD, MSU Center for Orthopedic Research |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
one year | No |