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

NCT ID: NCT01988259

Last Updated: 2015-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Brief Summary

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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

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Conditions

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Multilevel Cervical Spinal Stenosis Single Brachial Radiculopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bilateral approach for laminoplasty

Open approach for laminoplasty

Group Type ACTIVE_COMPARATOR

Bilateral approach for Laminoplasty

Intervention Type PROCEDURE

Open bilateral approach for laminoplasty in multilevel cervical spinal stenosis

Unilateral approach for laminoplasty

Minimally invasive approach for laminoplasty

Group Type ACTIVE_COMPARATOR

Unilateral approach for laminoplasty

Intervention Type PROCEDURE

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

Subperiosteal approach for foraminotomy

Open approach for foraminotomy

Group Type ACTIVE_COMPARATOR

Subperiosteal approach for foraminotomy

Intervention Type PROCEDURE

Unilateral subperiostal approach for single level foraminotomy

Transmuscular approach for foraminotomy

Minimally invasive approach for foraminotomy

Group Type ACTIVE_COMPARATOR

Transmuscular approach for foraminotomy

Intervention Type PROCEDURE

Unilateral transmuscular approach for single level foraminotomy

Interventions

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Bilateral approach for Laminoplasty

Open bilateral approach for laminoplasty in multilevel cervical spinal stenosis

Intervention Type PROCEDURE

Unilateral approach for laminoplasty

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

Intervention Type PROCEDURE

Subperiosteal approach for foraminotomy

Unilateral subperiostal approach for single level foraminotomy

Intervention Type PROCEDURE

Transmuscular approach for foraminotomy

Unilateral transmuscular approach for single level foraminotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jacek Cholewicki PhD

UNKNOWN

Sponsor Role collaborator

MSU Center for Orthopedic Research

UNKNOWN

Sponsor Role collaborator

Schoen Klinik Hamburg Eilbek

OTHER

Sponsor Role lead

Responsible Party

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Ralph Kothe, PD Dr. med.

Head of Spine Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ralph Kothe, MD

Role: PRINCIPAL_INVESTIGATOR

Spine Unit @ Schoen Klinik Hamburg Eilbek

Locations

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Schoen Klinik Hamburg Eilbek

Hamburg, City state of Hamburg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ralph Kothe, MD

Role: CONTACT

0049 40 2092 ext. 7001

Alexander Gude, MD

Role: CONTACT

0049 40 2092 ext. 7068

Facility Contacts

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Ralph Kothe, MD

Role: primary

0049 40 2092 ext. 7001

Alexander Gude, MD

Role: backup

0049 40 2092 ext. 7068

Other Identifiers

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MISDCS

Identifier Type: -

Identifier Source: org_study_id

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