Head-neck Coordination Analysis After Minimally Invasive Surgery in the Dorsal Cervical Spine

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Open vs Minimally Invasive Dorsal Approaches for Foraminotomy and Laminoplasty in the Cervical Spine Through Performance of Head-neck-coordination Analysis

Conditions
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Multilevel Cervical Spinal Stenosis, Single Brachial Radiculopathy

Intervention / Treatment
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* Procedure: Bilateral approach for Laminoplasty
* Procedure: Unilateral approach for laminoplasty
* Procedure: Subperiosteal approach for foraminotomy
* Procedure: Transmuscular approach for foraminotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bilateral approach for laminoplasty<br>Open approach for laminoplasty | Procedure: Bilateral approach for Laminoplasty<br>* Open bilateral approach for laminoplasty in multilevel cervical spinal stenosis<br>|
| Active Comparator: Unilateral approach for laminoplasty<br>Minimally invasive approach for laminoplasty | Procedure: Unilateral approach for laminoplasty<br>* Unilateral minimally invasive approach for laminoplasty in multilevel cervical spinal stenosis.<br>|
| Active Comparator: Subperiosteal approach for foraminotomy<br>Open approach for foraminotomy | Procedure: Subperiosteal approach for foraminotomy<br>* Unilateral subperiostal approach for single level foraminotomy<br>|
| Active Comparator: Transmuscular approach for foraminotomy<br>Minimally invasive approach for foraminotomy | Procedure: Transmuscular approach for foraminotomy<br>* Unilateral transmuscular approach for single level foraminotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |