Head-neck Coordination Analysis After Minimally Invasive Surgery in the Dorsal Cervical Spine (MISDCS)
Recruitment status was: Recruiting
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.
|Multilevel Cervical Spinal Stenosis Single Brachial Radiculopathy||Procedure: Bilateral approach for Laminoplasty Procedure: Unilateral approach for laminoplasty Procedure: Subperiosteal approach for foraminotomy Procedure: Transmuscular approach for foraminotomy|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- 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.
|Study Start Date:||September 2013|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Bilateral approach for laminoplasty
Open approach for laminoplasty
Procedure: Bilateral approach for Laminoplasty
Open bilateral approach for laminoplasty in multilevel cervical spinal stenosis
Active Comparator: Unilateral approach for laminoplasty
Minimally invasive approach for laminoplasty
Procedure: Unilateral approach for laminoplasty
Unilateral minimally invasive approach for laminoplasty in multilevel cervical spinal stenosis.
Active Comparator: Subperiosteal approach for foraminotomy
Open approach for foraminotomy
Procedure: Subperiosteal approach for foraminotomy
Unilateral subperiostal approach for single level foraminotomy
Active Comparator: Transmuscular approach for foraminotomy
Minimally invasive approach for foraminotomy
Procedure: Transmuscular approach for foraminotomy
Unilateral transmuscular approach for single level foraminotomy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01988259
|Contact: Ralph Kothe, MD||0049 40 2092 ext 7001||rkothe@Schoen-Kliniken.de|
|Contact: Alexander Gude, MD||0049 40 2092 ext 7068||agude@Schoen-Kliniken.de|
|Schoen Klinik Hamburg Eilbek||Recruiting|
|Hamburg, Germany, 22081|
|Contact: Ralph Kothe, MD 0049 40 2092 ext 7001 rkothe@Schoen-Kliniken.de|
|Contact: Alexander Gude, MD 0049 40 2092 ext 7068 agude@Schoen-Kliniken.de|
|Principal Investigator: Ralph Kothe, MD|
|Principal Investigator:||Ralph Kothe, MD||Spine Unit @ Schoen Klinik Hamburg Eilbek|