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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01988259

Acronym

MISDCS

Enrollment

100

Registered

2013-11-20

Start date

2013-09-30

Completion date

Unknown

Last updated

2015-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multilevel Cervical Spinal Stenosis, Single Brachial Radiculopathy

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.

Interventions

PROCEDUREBilateral approach for Laminoplasty

Open bilateral approach for laminoplasty in multilevel cervical spinal stenosis

PROCEDUREUnilateral approach for laminoplasty

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

PROCEDURESubperiosteal approach for foraminotomy

Unilateral subperiostal approach for single level foraminotomy

PROCEDURETransmuscular approach for foraminotomy

Unilateral transmuscular approach for single level foraminotomy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Performance of head-neck-coordination after surgery of the dorsal cervical spine	one year	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.

Countries

Germany

Contacts

Primary ContactRalph Kothe, MD

rkothe@Schoen-Kliniken.de0049 40 2092

Backup ContactAlexander Gude, MD

agude@Schoen-Kliniken.de0049 40 2092

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026