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

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.

Study Overview

• Status: Unknown
• Conditions: Multilevel Cervical Spinal Stenosis; Single Brachial Radiculopathy
• Intervention / Treatment: Procedure: Bilateral approach for Laminoplasty; Procedure: Unilateral approach for laminoplasty; Procedure: Subperiosteal approach for foraminotomy; Procedure: Transmuscular approach for foraminotomy

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22081
    • Recruiting
    • Schoen Klinik Hamburg Eilbek
    • Contact: Ralph Kothe, MD; Phone Number: 7001 0049 40 2092; Email: rkothe@Schoen-Kliniken.de
    • Contact: Alexander Gude, MD; Phone Number: 7068 0049 40 2092; Email: agude@Schoen-Kliniken.de
    • Principal Investigator: Ralph Kothe, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Schoen Klinik Hamburg Eilbek
• Collaborators: Jacek Cholewicki PhD; MSU Center for Orthopedic Research
• Investigators: Principal Investigator: Ralph Kothe, MD, Spine Unit @ Schoen Klinik Hamburg Eilbek

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: November 13, 2013
• First Submitted That Met QC Criteria: November 13, 2013
• First Posted (Estimate): November 20, 2013

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Bone Diseases; Radiculopathy; Spinal Stenosis
• Other Study ID Numbers: MISDCS