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

NCT01988259 | Unknown

• 1 other identifier: MISDCS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Multilevel Cervical Spinal Stenosis; Single Brachial Radiculopathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Bilateral approach for laminoplasty

ACTIVE COMPARATOR

Open approach for laminoplasty

Procedure: Bilateral approach for Laminoplasty

Unilateral approach for laminoplasty

ACTIVE COMPARATOR

Minimally invasive approach for laminoplasty

Procedure: Unilateral approach for laminoplasty

Subperiosteal approach for foraminotomy

ACTIVE COMPARATOR

Open approach for foraminotomy

Procedure: Subperiosteal approach for foraminotomy

Transmuscular approach for foraminotomy

ACTIVE COMPARATOR

Minimally invasive approach for foraminotomy

Procedure: Transmuscular approach for foraminotomy

Interventions

Bilateral approach for Laminoplasty PROCEDURE

Open bilateral approach for laminoplasty in multilevel cervical spinal stenosis

Bilateral approach for laminoplasty

Unilateral approach for laminoplasty PROCEDURE

Unilateral minimally invasive approach for laminoplasty in multilevel cervical spinal stenosis.

Unilateral approach for laminoplasty

Subperiosteal approach for foraminotomy PROCEDURE

Unilateral subperiostal approach for single level foraminotomy

Subperiosteal approach for foraminotomy

Transmuscular approach for foraminotomy PROCEDURE

Unilateral transmuscular approach for single level foraminotomy

Transmuscular approach for foraminotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• radicular or myelopathic compression syndrome in the cervical spine

You may not qualify if:

• neurological diseases with influence on the neuromuscular function
• previous surgery on the cervical spine

Sponsors & Collaborators

• Schoen Klinik Hamburg Eilbek: lead
• Jacek Cholewicki PhD: collaborator
• MSU Center for Orthopedic Research: collaborator

Study Sites (1)

Schoen Klinik Hamburg Eilbek

Hamburg, Hamburg, 22081, Germany

RECRUITING

MeSH Terms

Interventions

Laminoplasty; Foraminotomy

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Ralph Kothe, MD

  Spine Unit @ Schoen Klinik Hamburg Eilbek

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralph Kothe, MD

CONTACT

0049 40 2092; rkothe@Schoen-Kliniken.de

Alexander Gude, MD

CONTACT

0049 40 2092; agude@Schoen-Kliniken.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Spine Surgery

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 20, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

DE (1)