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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Schoen Klinik Hamburg Eilbek
Sponsor:
Collaborators:
Jacek Cholewicki PhD
MSU Center for Orthopedic Research
Information provided by (Responsible Party):
Ralph Kothe, PD Dr. med., Schoen Klinik Hamburg Eilbek
ClinicalTrials.gov Identifier:
NCT01988259
First received: November 13, 2013
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
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 Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Schoen Klinik Hamburg Eilbek:

Primary Outcome Measures:
  • Performance of head-neck-coordination after surgery of the dorsal cervical spine [ Time Frame: one year ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 100
Study Start Date: September 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988259

Contacts
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

Locations
Germany
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         
Sponsors and Collaborators
Schoen Klinik Hamburg Eilbek
Jacek Cholewicki PhD
MSU Center for Orthopedic Research
Investigators
Principal Investigator: Ralph Kothe, MD Spine Unit @ Schoen Klinik Hamburg Eilbek
  More Information

No publications provided

Responsible Party: Ralph Kothe, PD Dr. med., Head of Spine Surgery, Schoen Klinik Hamburg Eilbek
ClinicalTrials.gov Identifier: NCT01988259     History of Changes
Other Study ID Numbers: MISDCS
Study First Received: November 13, 2013
Last Updated: December 17, 2013
Health Authority: Germany: Medical Association Hamburg

Additional relevant MeSH terms:
Spinal Stenosis
Radiculopathy
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 28, 2014