search
Back to results

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

Primary Purpose

Multilevel Cervical Spinal Stenosis, Single Brachial Radiculopathy

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Bilateral approach for Laminoplasty
Unilateral approach for laminoplasty
Subperiosteal approach for foraminotomy
Transmuscular approach for foraminotomy
Sponsored by
Schoen Klinik Hamburg Eilbek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multilevel Cervical Spinal Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Schoen Klinik Hamburg EilbekRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Bilateral approach for laminoplasty

Unilateral approach for laminoplasty

Subperiosteal approach for foraminotomy

Transmuscular approach for foraminotomy

Arm Description

Open approach for laminoplasty

Minimally invasive approach for laminoplasty

Open approach for foraminotomy

Minimally invasive approach for foraminotomy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 13, 2013
Last Updated
May 21, 2015
Sponsor
Schoen Klinik Hamburg Eilbek
Collaborators
Jacek Cholewicki PhD, MSU Center for Orthopedic Research
search

1. Study Identification

Unique Protocol Identification Number
NCT01988259
Brief Title
Head-neck Coordination Analysis After Minimally Invasive Surgery in the Dorsal Cervical Spine
Acronym
MISDCS
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Schoen Klinik Hamburg Eilbek
Collaborators
Jacek Cholewicki PhD, MSU Center for Orthopedic Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multilevel Cervical Spinal Stenosis, Single Brachial Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bilateral approach for laminoplasty
Arm Type
Active Comparator
Arm Description
Open approach for laminoplasty
Arm Title
Unilateral approach for laminoplasty
Arm Type
Active Comparator
Arm Description
Minimally invasive approach for laminoplasty
Arm Title
Subperiosteal approach for foraminotomy
Arm Type
Active Comparator
Arm Description
Open approach for foraminotomy
Arm Title
Transmuscular approach for foraminotomy
Arm Type
Active Comparator
Arm Description
Minimally invasive approach for foraminotomy
Intervention Type
Procedure
Intervention Name(s)
Bilateral approach for Laminoplasty
Intervention Description
Open bilateral approach for laminoplasty in multilevel cervical spinal stenosis
Intervention Type
Procedure
Intervention Name(s)
Unilateral approach for laminoplasty
Intervention Description
Unilateral minimally invasive approach for laminoplasty in multilevel cervical spinal stenosis.
Intervention Type
Procedure
Intervention Name(s)
Subperiosteal approach for foraminotomy
Intervention Description
Unilateral subperiostal approach for single level foraminotomy
Intervention Type
Procedure
Intervention Name(s)
Transmuscular approach for foraminotomy
Intervention Description
Unilateral transmuscular approach for single level foraminotomy
Primary Outcome Measure Information:
Title
Performance of head-neck-coordination after surgery of the dorsal cervical spine
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ralph Kothe, MD
Phone
0049 40 2092
Ext
7001
Email
rkothe@Schoen-Kliniken.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Gude, MD
Phone
0049 40 2092
Ext
7068
Email
agude@Schoen-Kliniken.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph Kothe, MD
Organizational Affiliation
Spine Unit @ Schoen Klinik Hamburg Eilbek
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schoen Klinik Hamburg Eilbek
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph Kothe, MD
Phone
0049 40 2092
Ext
7001
Email
rkothe@Schoen-Kliniken.de
First Name & Middle Initial & Last Name & Degree
Alexander Gude, MD
Phone
0049 40 2092
Ext
7068
Email
agude@Schoen-Kliniken.de
First Name & Middle Initial & Last Name & Degree
Ralph Kothe, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs