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

Not Applicable

• Conditions: Single Brachial Radiculopathy; Multilevel Cervical Spinal Stenosis
• Interventions: Procedure: Bilateral approach for Laminoplasty; Procedure: Subperiosteal approach for foraminotomy; Procedure: Unilateral approach for laminoplasty; Procedure: Transmuscular approach for foraminotomy

• Registration Number: NCT01988259
• Lead Sponsor: Schoen Klinik Hamburg Eilbek

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-13
• Study First Posted: 2013-11-20
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral approach for laminoplasty	Bilateral approach for Laminoplasty	Open approach for laminoplasty
Subperiosteal approach for foraminotomy	Subperiosteal approach for foraminotomy	Open approach for foraminotomy
Unilateral approach for laminoplasty	Unilateral approach for laminoplasty	Minimally invasive approach for laminoplasty
Transmuscular approach for foraminotomy	Transmuscular approach for foraminotomy	Minimally invasive approach for foraminotomy

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Schoen Klinik Hamburg Eilbek; 🇩🇪 Hamburg, Germany